The FDA tracks complaints and problems with LASIK through its MedWatch program. LASIK facilities fail to report LASIK complications and complaints, and patients are not informed that they may file a voluntary report. For years, most LASIK complications were never reported to the FDA. LASIK problems continue to be grossly under-reported. In May 2008, the FDA put a link to the MedWatch online reporting form on the FDA LASIK website. Read a sample of MedWatch reports contained in the FDA Maude database below.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3370439
I had lasik eye surgery at lasik plus and my life hasn't been the same since. Suicidal and etc now.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3354582
Lasik surgery left me with double vision in one eye and the two eyes don't align, so i have triple vision. F/u surgery reduced this somewhat, so that the extra images are like ghost images, and i usually only notice 2 of them. Because i have large pupils and they did not increase the size of the flap to account for it, i get "edge" effects from the flap. This results in light diffraction. The effect is similar to looking through gauze. In bright conditions it can be quite pretty (my lawn sparkles like diamonds after the rain) but impairs my vision significantly (it's hard to see anything else while dazzled by a million diamonds) and impairs my ability to drive. Every point of light is a starburst coming from a bright "buckyball", and there's the ghost images of them to deal with also. The effects are often so bright that it is exquisitely painful. Polarized glasses help somewhat, but can't be worn at night or in other low light conditions. In dim lighting, the gauze effect can make it difficult to focus on things, a walk through the woods becomes a walk through shades of green that i can't determine the distance to. Date of event is approximate. (b)(6).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3360490
I had all laser lasik 8 months ago from lasikplus. Lasikplus glossed over the risks and recovery and did not provide accurate or thorough pre-lasik education. I was told the following: recovery period is 1-3 months with temporary starbursts that go away and temporary vision fluctuations that go away, the rate of under correction is 5%, cornea ectasia was briefly discussed with me and dismissed as a rare complication. This messaging is flawed: the flap cut by lasik never heals - this was not even mentioned to me. The true recovery period is much longer than 3 months, a realistic time-table was not provided to me. Starbursts were marketed to me as temporary but the reality is that they can be permanent and are not curable. Dry eye was not explained to me. There is no cure for dry eye. The 5% under-correction rate is misleading in that it is only a part of the story. The other part is that you could be overcorrected, or with an induced astigmatism, or with eyes that are not the same prescription as each other - none of which was discussed with me. I was not adequately pre-screened for dry eye nor was i educated about dry eye pre-operatively. My pupil size was not discussed with me and its potential impact on vision was not reviewed with me. My near vision - reading vision - was not evaluated pre-operatively. The lasik manufacturer's literature was not provided to me. I was not consulted with regarding my other options such as prk, lasek, contact lenses, or glasses. I was not consulted with on my personal goals and reasons for having lasik to ensure that these were in-line with what is possible with lasik. I now have fluctuating side blur on the temporal side of one eye. I have dry eye and am now on expensive therapies with a dry eye specialist. I have starbursts in low light/ darkness on light sources. These are annoying and disturbing to my vision. I have an astigmatism in one eye. I never had any of these problems prior to lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3370307
Surgeon reported that a pt was not satisfied with surgery results and is complaining that they see badly in the dark with opened pupil (8. 7-8. 8 mm). Entries in medical record indicate pt refused to use cholinergic eye drops. Surgeon also reporting pt has also complained about dry eye, however pt was recommended to use eye drops but refused any treatment. It was indicated that the surgeon detected anisometropia during the pt's last visit, however the pt refused an additional correction offered by the clinic specialists. The surgeon also reported pt is now having suicidal thoughts. This report references the left eye. The right eye, of the same pt, will be reported separately. Additional information has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3313897
I wish to report 21 post lasik/prk pts who developed a previously unreported, severely disabling and possibly permanent complication of the massive corneal nerve fiber axotomies performed during these procedures: it is an especially intense unrelenting form of neuropathic trigeminal pain including in many, painful photosensitivity. This pain had persisted 2 to 15 years at the time of the initial consultation. Because the suicide provoking intensity and unrelenting nature of the pain is masked by the typically normal appearance of these eyes and sometimes a significant delay in their onset, these symptoms have been dismissed as exaggerated or imagined. To my knowledge, this complication has not been previously reported. Despite my paper having been vetted by two neuroscientist-clinician experts on neuropathic pain, the paper was summarily rejected by the journal of the academy of ophthalmology and journal of cataract and refractive surgery. In both cases it appeared that the reviewers were surgeons who currently perform this procedure. My suggestion that one of the reviewers be an expert in neuropathic pain was ignored by both journals. Because of my concern that these rejections may have been motivated by self-interest, i have posted the paper on the website of my nonprofit (b)(6) eye pain. The paper can be accessed from the (b)(6). However, i would like to send you a pdf for your records and will do so if you will send me the appropriate email address where you can receive it. Mine is (b)(6).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3233918
I had lasik refractive surgery and 2. 5 months later started experiencing bright flashing lights in my left eye. I went back to the doctor whom performed my lasik procedure and was told that my symptoms were not related to my laser surgery. He referred me to a retinal specialist whom i saw the same day. The retinal specialist examined my eye and found two tears in my retina. He then performed surgery that day. I was told that the retinal tears were common with people like me who were nearsighted. I'm only (b)(6) and my nearsightedness prior to lasik was not on the severe side.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3229873
Had lasik eye procedure, performed at lasik plus in (b)(6). After one year, i have experienced chronic dry eye syndrome, to the point that my eyes are constantly red and dry and may require further surgery to correct this problem. Lasik eye surgery follow up dates: 1 week, 2 weeks, 3 weeks, one month, 3 months.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3209163
Had lasik surgery with the allegretto system and now i have severe dry eye disease. No treatment is working and it is costing my family tons of money that i am on the verge of not wanting to live anymore, help.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3202328
I had lasik surgery at (b)(6), that the surgeon said was successful. When i returned the next day for follow-up, i was told everything went well. A week later at a subsequent follow-up, i complained that i could not see out of my left eye. The nurse, (b)(6), said to me that the vision was probably overcorrected, and i would need surgery again. When the doctor came in, she said there was no overcorrection; i just needed time to heal. A month later, i complained about the same problem, and was told again that i just needed to heal. I was charged (b)(6) for temporary glasses to use until my eye healed. Two months later, at the next follow-up, i said again that vision was blurry out of my left eye, but again i was told that the surgery was successful and that i just took longer to heal than normal. I was scheduled for another follow-up 6 months later. I began to experience starburst, halos, double-vision, blurred vision, and severe headaches. I made an appointment with an ophthalmologist on (b)(6) 2013, who advised that because the corrected vision was so different in each eye -1 in the right, -4. 75 in the left, i would need glasses again to alleviate the symptoms and to see clearly.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3164508
I had lasik on both eyes in 2005 and developed cataracts in both eyes in 2011. I had cataract surgery in both eyes in 2013 as my vision was deteriorating rapidly. After both surgeries were complete, i was unable to see close up clearly and became extremely farsighted. I had to have a third surgery to implant a second lens in my left eye to correct the power. My doctor told me that this inability for an accurate measurement for iol after lasik was common. I am currently recuperating from this third surgery and am hoping for improved vision. I used the same doctor for both procedures. He was up front with me regarding the lasik as a potential cause of my cataracts. Dates of use: (b)(6) 2005. Reason for use: myopia.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2321288
I am a physician in [redacted]. I was evaluated and felt to be a good candidate for LASIK surgery in both eyes, with adequate corneal thickness. Within 2 years, I started noticing significant deterioration of my vision. I have been part of contact lens clinical studies, multiple refractions, and currently wear piggyback contacts in each eye in order to cope during the day. I am unable to drive at night and unable to wear glasses that will help to any degree. I have had to cut back my hours practicing as a physician as the reading and driving required are often prohibitive to me. I am now being evaluated for corneal transplant in both eyes. As a physician, I am appalled that this surgery was offered with this complication as a known outcome even for good candidates and am consistently appalled that it is advertised the way it is. I believe LASIK should be withdrawn.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2247854
I had LASIK surgery on [redacted] 2010. The doctor explained to me that I would have dry eyes for up to 6 months after the procedure. It has now been about 18 months since the surgery, and I still have chronic dry eyes. I put lubricant eye drops in my eyes at least a few times a day. When I reported this to the doctor at my 12-month check-up, her response was that I've probably always had chronic dry eye and I just notice it more now. I have never had a problem with dry eyes until after this surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2264099
Post-LASIK ectasia. I had LASIK surgery in 2004. My vision was excellent for 4 years. Then I began to notice that the sight in my left eye was beginning to degrade. Finally in 2010, I needed to get glasses again. At the end of 2010, I became concerned at how fast my glasses were no longer strong enough. I was needing a new prescription around every six months, but this time, I noticed a problem just two months after my last new pair of glasses. My eye doctor suggested that I might have keratoconus and referred me to an ophthalmologist, who confirmed that I was likely experiencing post-LASIK ectasia, not keratoconus. I have since gotten hard contacts, as my vision can no longer be fully corrected with glasses. My insurance refused to pay for them, so I had to pay [redacted] out of pocket for them. Just in the couple of months that have gone by in the fitting process, it appears that my left eye has degraded even more. I am very concerned that I will eventually need a corneal transplant. [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2274714
[Reported by manufacturer, Technolas Perfect Vision] A pt reported undergoing LASIK in both eyes in 2006 to treat nearsightedness (approx -4. 75 d). Postoperatively the pt reports having 20/20 vision, but the pt is dissatisfied because of continuing problems with halos, ghosting, dry eyes, and induced astigmatism. In addition, the pt reports experiencing poor night vision, loss of contrast, and loss of sharpness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2280331
I had LASIK surgery at the LASIK Saddleback clinic. I still need to wear glasses regularly and to drive and I now suffer from chronic dry eye. I have been taking Restasis ever since.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2280291
Lasik surgery followed by continuing glare and halo problems since the surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2281654
Dr. [redacted] performed a failed LASIK surgery. Symptoms resulting from operation include dry eye, blurry vision, reduced vision, poor night vision, unable to wear contacts or correct vision with glasses. [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2285523
I had LASIK on both eyes in [redacted] 2010. Since then, I have spent [redacted] and spent countless hours at the doctor. My left eye is almost as good as it was prior to LASIK. My right eye on the other hand is no where near where it was prior to LASIK. My vision is blurry. I can not read 20/20 on the eye chart. I am lucky that I can still see out of my right eye. I reported to my LASIK doctor that I was having problems and he dismissed me. This has devastated myself and my family. I was told prior to the surgery that I would be able to return to normal after about one day post op. That is so not true. I am currently on over the counter eye drops, Restasis, Pred Forte and Combigan. My current IOP is in the 20's as a result of the steroids and the glaucoma med. I have had steroid induced glaucoma as well as three incidences of DLK -Sands of the Sahara-. When I told Dr.[redacted] of [redacted] that I was having trouble seeing he told me I must have health issues and to see a doctor. After seeing every kind of doctor under the sun; chiropractor, family doctor and a psychiatrist, I got a second opinion from a different ophthalmologist who diagnosed me with DLK and started me on the steroid and returned me back to Dr.[redacted]. After many more months of poor vision, I consulted with a third ophthalmology office who concluded that after not having my pressure checked and being on steroids non stop, I was a steroid responder. This doctor told me to discontinue the steroids and return to Dr.[redacted] for f/u. Ten months op and I am still seeing Dr.[redacted] with no improvement in my vision. He never performed an enhancement but he did lift the flap and irrigate it at one point.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2302183
I had LASIK surgery a year ago that has given me severe dry eyes. I have to use eye drops every 15 minutes and my eyes still hurt every day and they get worse throughout the day. By evening, I can barely keep my eyes open. I even have to use drops throughout the night when I sleep. A lift that was normal with glasses is now horrible without glasses. It's not good that these doctors are not checking tear production before surgery but dry eye is the number one complaint after surgery. The doctors make you feel so comfortable with the procedure saying you will be fine that side effect are very rare. Now after the surgery, my eyes are terrible dry, my Dr. decides to do a tear test and says here are some eye drops, there is no cure for dry eye. I can say this has been the worst decision of my life and my family has to suffer with me. I'm very young [redacted] and have to live with this the rest of my life. Something needs to be done about this. Drs shouldn't be able to butcher peoples' eyes at such ease. They should have to be able to do tear production test before the procedure. Now that I know what dry eye is, I can remember times before the procedure where I had some mild dry eye. I know if the doctor had checked for it she would have seen it. I can't say it enough: something needs to be done. On top of all that research for dry eye relief is moving at a snail's pace. We really need to step it up. Thousands of dry eye patients out here need help, relief and comfort. Bilateral custom wave front LASIK [redacted] 2010. [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2306830
I had LASIK and about a couple of weeks afterwards I noticed when I looked on the horizon, it would pulsate, as I would say. None of the doctors knew what the matter was. Months later my vision would pulsate when I was at a conference or seminar and I'd look way down at the presentor. Several months later it would be across the room until finally my eye started to cross. Then it got closer and now anything past 3 - 4 ft, my eye will cross. I have to live with one eye shut. I have to drive with one eye shut as I can not function. I don't have a product. I'm just wanting to report LASIK has ruined my life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2312470
[Reported by manufacturer, AMO, VISX laser]. The clinic reported that a laser vision correction pt presented with severe dry eye at the post op exam. The pt indicated having blurry vision and burning. The pt was implanted with lacrimal punctate plugs but complained of epiphora and irrigation from the plugs. The upper plugs were removed. The pt expressed dissatisfaction with the results and is upset with the delayed recovery. Artificial tears were prescribed for the dry eye and the pt is continuing to be monitored. The pt's uncorrected visual acuity is 20/25-1 in the right eye and 20/50 in the left eye. Best corrected visual acuity is 20/20 in the right eye and 20/25 in the left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2326817
Pt describes progressive worsening of night time blinding by oncoming auto-headlights which show a stellated refractile pattern. Blinding light instantly corrected after oncoming auto passes. No delayed sight in night. No true night blindness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2329769
Lasik surgery to left eye. Prior vision 20/20-2 in the left eye. Prior dry eye due to medications. Told he was a candidate for LASIK mono vision. Surgery done on left eye. Vision now 20/400, pain, severe dryness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2338616
The clinic reported that a laser vision correction pt presented at the 5 day post-op examination with an overcorrection in both eyes and a loss of best corrected visual acuity (BCVA). The pt's BCVA in the right eye is 20/40 and the BCVA in the left eye is 20/30.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2334675
Nurse reports laser is unstable, and a patient that underwent surgery for 2 diopters of myopia resulted in 9 diopters of hypermetropia postoperatively. Further information has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2334676
Nurse reports a patient that had preoperative myopia was hyper corrected by 1 diopter postoperatively, and that the patient also shows central island. Further information has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2334939
I had LASIK in [redacted] 2011, I was having flashing lights in my right field of vision and went to the ER and then to eye specialist and was diagnosed with posterior vitreous detachment. I am now having other problems in my right eye reduced vision, swollen optic nerve, and irregular color vision between two eyes, and possible epiretina membrane. I am waiting for more test results to come back. I do believe I maybe having these issues due to having LASIK.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2344264
I had LASIK surgery. I have been having dry eye with pain in the right eye. Sometimes the pain is really bad and other it is tolerate. I just want no one to go through this kind of daily pain. Drs should have to give more info on the side effects of this procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2348880
An AMO medical monitor reviewed the pt charts and indicated that he and the treating doctor were not able to determine the reason for the decentered ablations. The customer did not report this issue to AMO when it occurred and did not request field service for the equipment or clinical support. A review of our service records reveals that the equipment was serviced about 6 weeks after the event for an unrelated issue. All pertinent info available to AMO has been submitted. Should new info that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2345348
Bilateral LASIK with Wavelight 400 excimer laser. Uncomplicated treatment and permanent night vision blur, not responsive to miotics not spectacles with anti-glare coating. No significant refractive error, not a large pupil. Debilitating night vision, cannot drive at night. Significant wavefront errors on wavefront mapping. Low spherical aberrations, but high coma and trefoil wavefront aberrations following wavelight custom adjusted treatment. Pre op refraction: OD -2. 75 - 0. 75 x 169 OS - 2. 75 - 0. 75 x 17 scotopic pupil: OD 7. 98 OS 7. 67 post op refraction: OD plano - 0. 44 x 140 OS plano - 0. 21 x 45 uncorrected VA: OD 20/20, OS 20/15. [Reported by manufacturer, not by patient. The patient most certainly does have large pupils based on this information].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2240760
Please help me. My vision has been permanently damaged and there are no resources to help me. This procedure has robbed me of happiness and the ability to participate in the hobbies and activities I was engaged in prior to having LASIK. My poor vision also impacts my ability to perform my job as a [redacted]. There is no way to describe what it is like living with vision like mine. My life is falling apart because of this completely unnecessary procedure... (continued)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2247854
I had LASIK surgery on [redacted] 2010. The doctor explained to me that I would have dry eyes for up to 6 months after the procedure. It has now been about 18 months since the surgery, and I still have chronic dry eyes. I put lubricant eye drops in my eyes at least a few times a day. When I reported this to the doctor at my 12-month check-up, her response was that I've probably always had chronic dry eye and I just notice it more now. I have never had a problem with dry eyes until after this surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2220440
CustomVue IntraLase: Had Lasik in [redacted] 2008 with refractive error of +7.25 in right eye and +5.25 in left eye. Had good initial vision, but had halos and starbursts at night. Year later, right eye regressed had enhancement. Helped a little. In 2011, right eye and left eye have slipped. I was told I would be able to wear contacts post Lasik, but am unable to be fit with them. Eye exams are difficult due to the glares off of the Snellen chart. What was supposed to make my life more convenient has done the opposite. Had surgery in [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2215666
I had lasik done in 2002 by [redacted]. I have had night time vision problems. Now I have eye pain from a problem flap.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2190642
I had Lasik at [redacted], surgery performed by dr [redacted]. After the first surgery on [redacted] 2001, a week later, things went blurry and night vision problems. After nearly 3 months later, an enhancement was performed; however, problems still persisted, and made it worse. Post op care was very poor, the operating surgeon, Dr. [redacted], did not even have the courtesy to see me afterwards. Now 10 yrs later, I suffer from Lasik ectasia/keratoconus.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2190688
Botched lasik surgery leads to halos, starbursts, dry eye, pain, depression, suicidal thoughts, and discomfort.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2175167
I had LASIK eye surgery done by Dr. [redacted] in [redacted] in [redacted] 2005. I had 20/15 vision after the surgery, and I was thrilled. About five years later, I developed blurry vision and now have a lot of trouble with my eyes. I have developed an astigmatism, and I have been having a lot of trouble getting this corrected. I have been to four eye doctors over the last six months.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2169488
A patient reports experiencing serious injuries to both eyes after LASIK surgery. The injuries were reported to have been caused by improper treatment entry by the laser technician. The patient stated pre-op bcva was -5 in both eyes with contact lenses. At one day post-op, the patient stated vision was very poor. The surgeon's examination showed both eyes were -13. The surgeon stated to the patient that the technician entered the incorrect treatment plan for both eyes. The patient sought another surgeon's opinion and was told the corneas were too thin for further treatments, she had astigmatism and aberrations. The patient has declined to provide further information on advice from her attorney.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2176660
Manufacturer Narrative
Field service on the equipment was not required. The amo clinical development manager (cdm) and the amo medical monitor reviewed the pt charts. The medical monitor recommended against further treatment and indicated that the pt's pre-op charts are suggestive of keratoconus. The clinic indicated that they would not perform any further treatment on this pt. No further info is available.
Event Description
The customer initially contacted amo with advice on performing an enhancement on a pt. The clinic reported that the pt treated for laser vision correction presented at a 5 month post operative exam with a 2 line loss of best corrected visual acuity (bcva) in the right eye (od). The pt's pre-op bcva was 20/20 od and the pt's post-op is currently 20/30 bcva od.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2163552
I had LASIK and now have ectasia. My vision changes every six months.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2153237
Had LASIK surgery in 1997 and 1998 from [redacted] eye center in [redacted]. I was very near sighted [redacted]. I needed two enhancements for a total of three surgeries. I have experienced dry eyes and gradual near sightedness. My optometrist has diagnosed me with ectasia as a result of my surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2145741
I had LASIK surgery in 2001. This was the worst decision I have ever made. My eyes became severely red, dry and irritated. I have seen over 9 eye doctors since 2001, have tried every available eye drop, over the counter and prescribed available. I take multiple vitamins to try and maintain the little eye health I have left. From inserting plugs constantly into my eyes, to having them removed because the water would drain down my face all day, I now have scar tissue on my right upper plug that makes this eye have a mucus film drain from it constantly. This procedure should be stopped now before anyone else has to deal with the constant struggles of everyday life after LASIK surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2143863
[redacted] LASIK surgery in [redacted]. Corrected to 20/20 right after surgery but gradually declined to about -1 diopters within the first yr. Currently -5. 5 in left eye and -3. 5 in right eye. Have had continual visual shifting with frequent prescription changes due to "post LASIK corneal instability. " have had to be fitted with hybrid contact lenses. Referred to neuroopthomologist due to frequent changes in vision. No evidence currently of neurological etiology. All structural post LASIK.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2095463
Reported 5/15/2011: I had two LASIK eye surgeries in 1998, using a VISX star laser. The surgery was done to correct myopia and astigmatism. The surgery was performed twice on each eye; once in [redacted by FDA] and once in [redacted by FDA]. I knew going in that I would need two surgeries because of the extent of my myopia (approximately -12. 50 and -13. 50). Initially, my vision was good following the second surgery. However, my vision has deteriorated in subsequent years and continues to get worse. I have starbursts, halos, glare, and ghost images at night. Neither contacts nor glasses have been able to help these problems. I have recently begun seeing double images, starbursts, and glare sometimes during the day. I don't know what the future holds for my eyes, but I am worried that the deterioration will continue. There seems to be no solution. No one seems to understand the impact that this loss of vision has had on my life. My eye doctor talks as if I should be grateful because using the eye chart I can see around -. 05 in both eyes with a slight astigmatism. However, the crazy images I see have led me to be depressed to the point of considering suicide at times. I have not received a good explanation for why my vision is deteriorating. Three parties were involved in these events: my O.D. , the surgeon, and the center where the surgery was performed. All of my follow up has been with my O.D. Who recommended the surgery and set everything up. I believe they all had my best interest at heart. I report this event not to point fingers at anyone, but to warn others that this surgery has serious risks. I do not want anyone else to go through what I am going through every day, probably for the rest of my life. Dates of use: [redacted by FDA] 1998.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2048252
Lasik surgery that caused decreased night vision and decreased night depth perception. Read that enlarged pupils may be cause. I was never advised this could be a problem with LASIK surgery although eye doctors had told me I have enlarged pupils. Eye doctors also advised that I was a good candidate for LASIK surgery and my vision since is 20/15 and has maybe changed to 20/20. My vision before was 20/450.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2045913
Severe dry eyes night vision problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2016323
Had LASIK surgery done. I was told I was a good candidate, that I would have close to 20/20 vision, and that my focal point of sight would be about 14 inches from my eyes. They did mention complications, but told me that the possibility of having them was remote and had me sign a disclaimer waiving any possibility of holding them responsible if I had problems. My following check up showed my vision was not 20/20 and I was told my vision was better than they thought it would be. I was seeing as well as I did with my glasses, and I needed a stronger prescription when I went in. I now have severely dry eyes causing my eyes not only to be dry, but my nose now constantly runs. I not only see halos, but if I'm looking at a person sitting with their back to a window I can't see them- it's like they are sitting in a fog. My night vision is terrible, so much I don't drive at night unless I have to and only if I'm familiar with the route. I can't see anything up close and need reading glasses, and my point of focus is about 18 inches from my face, making the needlework I love to do extremely hard and tiring. I also see starbursts from any light source at night.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2013465
Approximately 4-6 months after I had lasik surgery I developed severe dry eye, starburst vision -more severe at night-, and decreased vision clarity. The dry eye and decreased vision clarity is intermittent, but the starburst is constant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2016330
After having LASIK done, my eyesight has continued to deteriorate. I should never have been a candidate for the surgery due to my high prescription, and overly large pupils. Even the doctor said "your eyes were the worse I've ever done" right after he finished. Glasses cannot correct my blurry vision due to my eyesight being so unstable. I've had to give up reading for longer than ten minutes because I get headaches trying to focus, driving at night in unfamiliar areas due to such bad vision in low light, working on a computer for any extended length of time. I could go on and on. I have all the complications everyone else does. My eyes continuously water. Halos, aberrations, unstable vision, pain, distortion. Why are we still allowing this surgery to be performed. I hope the FDA does its job, and yanks the approval for this butchering. How many others have to end up like this before they get it? I am applying for disability because I can't see well enough to work anymore. I'm only [redacted by FDA]. What do I do now?
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2019933
I had LASIK surgery on [redacted by FDA] 2007. The surgery was performed within 4 hrs of my initial visit. I have not had clear vision since the day of surgery. My problems include dry eyes, halos, starbursts, no contrast ability, lack of peripheal vision, extreme sensitivity to light, and now bilateral cataracts. I was told at every visit that these complications would resolve over time. Of anything, my symptoms have become worse. I faced an unk amount of surgeries to remove the cataracts and I am concerned about the instability of my corneas, which have been damaged and will at some point require corneal transplantation. At the time of my surgery, I was earning in excess of [redacted by FDA] per yr. Due to my declining visual ability and debilitating depression, I am on [redacted by FDA], wherein I receive a monthly stipend of [redacted by FDA]. I have attempted suicide more than 5 times since my LASIK.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2021735
I had LASIK surgery in [redacted by FDA] 2006 and I have been struggling with complications since. Before my surgery I was assured I had < 1% chance of having GASH or any other long term complications. I noted this on my consent form. Prior to the surgery I told the surgeon I have a very low tolerance for a bad outcome and GASH. He repeatedly told me "pupil size is not a good predictor of poor post LASIK night vision. " he assured me that as a "compatriot" he would take good care of me and that I "would do fine. " Immediately following surgery, I developed dry eye which is worsening. I developed all the GASH symptoms even though I was told I had < 1% chance of having any long term complications. The possibility of dry eye was never discussed with me. The only complications we discussed were GASH because I initiated. After complaining about dry eye my surgeon told me I had dry eye before surgery. I thought this was a contraindication for LASIK. Other contraindications for LASIK: pre-existing dry eye, occupation -computer programmer-, large pupils, high correction, astigmatism, medications, long term contact lens use and possibly cataracts. I have been seeing the surgeon the entire time for follow ups, GASH, dryness and cataracts with no resolution in sight. This has severely impacted my life to the point where my 3 yr relationship with my fiance ended. I am finding it very difficult to concentrate/work and I have become depressed as nothing helps and the Drs are stumped.
Editor's note: GASH stands for glare (or ghosting), arcing (or astigmatism), starbursts, and halos. Emphasis added.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2023576
Bilateral LASIK surgery to correct myopia and laser used was off center causing uneven cornea surfaces and warping of the cornea. Astigmatism, and dry eyes requiring prescription strength medication to correct. Note: on day of my surgery, the laser machine was sitting on a pallet jack. I did not see this but my husband did. He inquired about it and was told by one of Dr. [redacted by FDA] staff members, [redacted by FDA], that it was ok sitting on the pallet jack. They left it there so they could load and unload it onto a truck to take to their other locations. [redacted by FDA] told my husband that the laser machine constantly calibrated itself. Dr. [redacted by FDA] [redacted by FDA] 2010. Dr. [redacted by FDA] [redacted by FDA] 2010, Dr. [redacted by FDA] [redacted by FDA] 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1963737
After having LASIK eye surgery, corneal ectasia has occurred, with decrease in vision prescription and starbursts and halo that make night vision extremely difficult.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1964033
I had wave front LASIK in [redacted] 2010. My vision was corrected to 20/20 in right eye and to 20/25 in left eye after surgery. Immediately after surgery vision in my left eye got blurred. I am 9 months post op as of now, the vision in my left eye still same blurred. On top of it, two months after the surgery, I started developing floaters in both eyes. They just getting worse since then. Floaters extremely distracting during the day time, and on all bright backgrounds. Blurred vision in my left eye constantly distracting me while night driving. Since I can read 20/25 I am considered LASIK success. This is no way how doctor can come up with such statements, I am suspecting that a lot of LASIK "success" info is just simply misapprehended to public. I would like to get back to my glasses but no such way.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1951935
Lasik procedure resulted in torn cornea and additional corneal surgery and chronic severe dry eye syndrome. Also experiencing halos and starbursts at night. Performed at [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1951972
Had LASIK surgery in 2007 in both eyes. Left eye problems include massive starbursts at night, halos, dry eye, eye callous, ctk, folds, skin ingrowth near flap, pterygium. Right eye problems severe dry eye, halos, glare, minor starbursts. Lasik re do surgeries [redacted] 2007, [redacted] 2007 and [redacted] 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1950873
Five years post LASIK surgery began progressive and severe night vision, I do not drive at night except in a well lit city. Had bilateral LASIK 2002, at the time no problems. I receive annual eye exams. Last exam [redacted] 2010. [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1951117
Dr. [redacted] performed LASIK procedure on me on [redacted] 2000. Eyes after six-years went bad because of thin corneas due to surgery. Would like to communicate to avoid this with other pts in future. Lasik procedure done by dr. [redacted] m. D. With nidek ec-5000 excimer laser. Resulted in loss of correctional sight. Diagnosed with LASIK induced thinning of corneas keratoconus.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1950663
Had LASIK eye correction surgery in 2003. Vision started to deteriorate a few years later requiring glasses. Left eye started to require high astigmatism correction -5- that I couldn't tolerate because of dizziness. In 2009, was diagnosed with ectasia of the left cornea for which I started wearing rigid gas permeable contact in the left eye with glasses for correction of the right eye. Had corneal collagen cross linking in [redacted] because it has not been approved by the fda in the usa. Now having severe night vision problems including double vision and halos. [redacted].
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1950680
I had LASIK in [redacted] 2010, and it has been the worse thing I have ever done! I have dry eyes and depression and back anxiety and I was never told the side effects or what bad could happen like retinal detachment due to the ring they use for suction! why didn't you guys do anything soon about LASIK a long time ago when people were having problems then? just do something about it! I have bad anxiety attacks and depression due to it now! LASIK! I do not approve of it!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1944031
The LASIK procedure has left me with very little sight in the right eye and an on going and progressively worsening left eye problems. Scar tissue seems to have developed in the right eye over six years and as previously mentioned is doing the same in the left eye. I'm told by every ophthalmologist eye surgeon that there is no remedy.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1944059
I had intralase LASIK surgery two years ago. I now suffer from severe dry eyes and it is only getting worse. My dr has run out of options to help. I have been on restasis, inserted plugs, use steroid drops and artificial tears, use oral supplements biotears fish oil, and even wear moisturizing goggles at night. No relief! I can't get more than a few hours of sleep each night and now suffer from depression. My life has been destroyed by the butcher dr that is completely unsympathetic and in a mad rush to get his next victim. Noteworthy: during the procedure, the dr said that my eyes were "bubbling" and had to stop for about 45 minutes to allow them to settle. It was 45 minutes of torment severe burning. He then completed the procedure. Perhaps something went wrong and the reason my eyes have been damaged. Dates of use: [redacted]2008. Diagnosis or reason for use: to correct -1. 5 nearsightedness. (b)(4).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1942173
I underwent LASIK with the visx star 4 laser with intralase. Now I have substantial night vision disability that is getting progressively worse. I was never a good candidate for the procedure. The fda's only contraindication for the procedure is not to leave a corneal residual bed less than 250 microns. I started with a 500 micron cornea and had a -8. 00 diopter correction that left about a 280 micron corneal bed. The treating surgeon and 2nd opinion don't even want to try an enhancement via LASIK but via [redacted] which risks corneal haze because of the thinness of the cornea. My preop pupil size was 8mm. With the correction needed and my pupil size, my night vision disability was guaranteed. The visx laser is only approved for an optical treatment zone of 6mm with an 8mm blend. The surgeons make you sign a huge consent form that guards them against litigation but they otherwise truly fail to inform the pt of their risks. The fda must have more stringent criteria for the indications of this procedure. This is an elective procedure but truly a medical procedure. This is being treated like a cosmetic procedure. There are too many eye disorders that are being created by overindicating high risk pts. The public needs to be protected. I am a physician and surgeon. I know that it does not matter what you post on your web site with regard to risks. Even a relatively safe procedure can be risky if performed on the wrong pt. Pt selection is crucial. The criteria for undergoing LASIK needs to be more stringent with regard to pt selection. Moreover, the fda is too focused on visual acuity with regard to evaluating success. There are many more facets to good vision than acuity. Contrast sensitivity at night and night vision are important aspect of overall vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1905783
Had LASIK eye surgery on [redacted], 2010. Now cannot see to do any of my daily tasks. Near and mid-vision are gone. I only see far away. Was only told I would need readers for the computer. Local doctor can't believe how farsighted they made me. I am preparing to commit suicide after I get me affairs in order for my children. Only those who have gone through this nightmare understand the guilt and shame. You spend thousands of dollars and have no recourse whatsoever when the outcome is bad. It is a great scam for the LASIK centers. Where on earth could you buy a product and then not have any recourse if it does not work??? Please put a stop to this before others die or ruin their lives!!! Please listen to us!!!
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1908898
Prior to LASIK surgery, I never had a problem with dry eyes. They explained that any risks associated with LASIK eye surgery is very rare, although I believe I did sign a consent related to this. Now, post-LASIK and 7 months later, my left eye is continuously blurry. I see stars around car lights and halos at night. Some days are so bad, I can't see anything clearly at all. The doctors at Nationwide have told me that I have "dry eyes", and that part of my cornea is "sloughing off" due to the dryness, in the cornea. This sloughing is causing a film over my left eye, and therefore prescription glasses wouldn't even help. The right eye is also dry, but not as bad as the left. I also have headaches frequently, which I never did before the surgery. They are now telling me I have to use eye drops every 30 minutes to 1 hour on a daily basis, and that it should get better. What I'm reading though is that this could be permanent, and this really scares me.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1916830
I had LASIK twice now. The first time on [redacted] 2010. As a result of LASIK, I had the following complications: overcorrection which caused me constant strain and pain -severe loss of near sight due to overcorrection -extreme starbursts and halos at night -loss of vision in dim settings which also caused my eyes to strain -daily pain and discomfort and pressure in brow area -constant blood shot eyes. I underwent the enhancement on [redacted] 2010. While it seem to have helped with some issues, I still have: daily strain -severe starbursts and halos at night -loss of vision in dim settings. This still causes my eyes to strain and I feel daily pressure in my brow area. I also feel pain in my left eye. It is difficult to drive at dusk and night. My pupils are very large and I was never informed about pupil size. Nor were my eyes ever dilated. I know this is a problem as most of my issues are at night and in dim lighting. LASIK is not safe.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1919702
Exact date not in front of me, but my wife had a LASIK procedure done in [redacted] 2009 at the [redacted] laser eye center in [redacted] by Dr [redacted]. Within hours after the procedure, she experienced extreme discomfort and it was painful to open her eyes and had difficulty sleeping due to pain. The pain was primarily a sensation of extreme dry eyes with burning. The pain improved slightly after one month, but the dry eye sensation was still severe. Over the last year, the discomfort of dry eye has shifted to photophobia or extreme sensitivity to light. Over the last year, she finds extended reading, computer work, and even going outside on a bright day intolerable. She wears sunglasses almost constantly, even indoors and at night since normal lighting makes her very uncomfortable. She has been diagnosed with corneal neuralgia which is a form of complex regional pain syndrome -assumed that this nerve disorder developed secondary to the LASIK procedure. She has a degree in biomedical engineering and was working for several years prior to the procedure. She has been unable to work since the procedure since her primary function was using spreadsheets or programming on a computer. This has been devastating to our life and we are currently under the care of pain mgmt with little to no improvement. She has developed secondary anxiety and depression due to the fact that she can no longer perform the job she used to do nor enjoy most of the activities she previously took part in -reading, movies, TV, outdoors.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1917771
For the last couple of years and has progressively gotten worse, I have bad night vision. When I had my LASIK done for free -through local TV station 1/2 hr live special-, I have had issues with night driving or halos. However, after I had the surgery, it was corrected. Now, about 8 years later, it has progressively gotten worse to the point, I hate to drive at night or even look at my TV when it is light lettering and a dark background. It is completely 100% worse than it was when I first got the LASIK surgery. I was picked for the television episode because out of all the 5 or 6 people interviewed, I was the "easiest" to do and the outcome would be great for them to promote their product. This was done through LASIK. It is becoming unbearable and a nuisance.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1916554
Had LASIK correction of my extreme near sightedness [redacted] 2004, contact strength were negative 11. 0. This resulted in star bursts and halos making night time driving very difficult to do. The halos and starburst have not gone away matter of fact they are worse now. Spring 2010, I experienced posterior vitreous gel detachment in the right eye, the MD stated that was directly caused by the LASIK that I had done on my eyes. The floaters in my line of sight in my right eye are interfering with my life. They never go away, they constantly move about. I am an RN and find that the star burst, halos, floaters -and now double images at times- are making my job difficult. At home I rarely pick up a book, nor watch TV, nor use my computer due to the discomfort I feel, the straining I do in order to try to focus clearly, which I can't achieve. By the way, I forgot to mention the constant state of dryness of both eyes, it feels like something is in them all the time. I would never ever have done this to myself if I would have been properly informed of the potential side effects and complications post LASIK, I would have happily continued to wear my contacts and glasses the rest of my life. Now I have doubts as to what is going to happen with my vision especially since one MD stated that I will have retinal detachment with probably blinding in my future. I tell everyone that I hear talking about maybe getting LASIK done to not do it!! It is not worth the damage that they do to a person.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1878198
I had LASIK at [redacted] eye Ctr in [redacted]. At one month post-op, there was an epithelial ingrowth in my right eye. He continued to try and remove it four times without any luck. He also performed an enhancement during this time, which resulted in a 1. 25 hyperopia and a 1. 25 astigmatism. I believe I was the victim of malpractice. I had to ask to be sent to a specialist. The specialist has been able to reduce the amount of farsightedness and astigmatism. I am still having trouble with the epithelial ingrowth. I suffer from nighttime starbursts, halos, decreased vision in low light, and severe higher order aberrations. I have been experiencing anxiety and the feeling of hopelessness. It tears me up inside when my [redacted] daughter talks about her daddy's boo-boo on his eye. I believe my doctor, [redacted] reported my LASIK outcome as successful. I was not informed in a meaningful way of the risk/outcomes that were to follow. I now have fear of anyone getting near my face. I find it extremely hard to drive at night due to massive starbursts. I also see numerous moons and all other objects. Lasik has been the worst thing that has ever happened to me. I regret it every moment of every day. Please take this into deep consideration and put a stop to the LASIK industry so that no one else has to go through what I and thousands of other are going through. I consider my case to be a very adverse outcome. I believe most people do not know or have not taken the time to file a Medwatch. Just Google it, and you will see that there are thousands of people out there and that the % of bad outcomes is much higher than reported.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1887552
After custom Intra-lase on both eyes to correct myopia, I suffer from double vision -diplopia- due to exotropia. Before surgery, because I was slightly overcorrected with my contact lenses, I did not suffer from double vision or exotropia. The doctors who screened me for LASIK failed to check for this or notice the problem, and now, I suffer from severe daily pain, eye strain, and double vision. Prism lense and vision therapy have thus far not been able to treat the problem successfully. I also suffer from ghosting which impairs reading and computer work, and night vision problems, including large halos, starbursts, etc. These were not present a few months after surgery, but have gradually become worse starting at about six months after the LASIK and continuing to the present. Finally, I suffer from dry eye. Collectively, this has been painful, debilitating, frustrating, and traumatic. My faith in the country, in humanity, in doctors has suffered a blow. Many doctors just want to protect LASIK, they don't want to help me. I have quit one job due to the condition and I am struggling to finish a PhD program. I may not be able to continue in the profession I have been trying for half of my life to enter -scholar of literature-. I suffer from anxiety, depression, and my life isn't the same. Please help regulate this industry which needs it so badly.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1843552
Bilateral Intralase LASIK performed in [redacted] 2010, using the VISX CustomVue system. Pre surgery prescription OD -3. 14 ds -0. 32dc, OS -3. 12ds -0. 66dc. Prior to surgery, no dry eye conditions, excellent corrected low light vision, no appearance of floaters, no history of chronic headaches, no history of suicidal thoughts. Three months post surgery complications - pain in the right eye accompanied by headaches, dry eyes, appearance of many dark floaters, starbursts and halos around bright light sources -in both low and moderate lighting conditions-, reduced contrast sensitivity - reduced ability to see well in low lighting-, induced astigmatism. These conditions result in reduced ability to drive at night, reduced ability to concentrate while on the job, reduced ability to participate in activities and everyday tasks in low light settings; increased sensitivity to bright light, increased depression, increased anxiety.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1842497
Event Date 01/15/2010. I had custom LASIK surgery [redacted] 2010. I was high prescription -8.5 near-sighted with astigmatism. Prior dry-eye issues, but not extreme. Very active. A 15-year vegetarian. Since surgery, I have never seen clearly again. It is scary to drive at night since I cannot see street signs or turns until it's too late to turn or completely miss the turn, and I have almost caused 4 car accidents. I experience double vision, blurry vision, weird focusing problems with movement or near-to-far, headaches, and dry eyes all the time. My left eye - I can see, but it is inferior to contacts, only with good light when not experiencing the other problems. My right eye - has never been clear. The right is always blurry near or far and, I experience more problems with double vision and dryness etc. I have gone back several times for examination as to my blurriness, etc and am told there is nothing they can find. It has been almost a year now with no resolution. I continue to use eye drops -their suggestion- often which do not give any real relief to the problems I experience and Advil doesn't help the headaches as they are caused by weird focusing issues that make me dizzy and tired. When in crowds of people I feel self-conscience since I cannot see, especially at an evening event. When going to [redacted] or shopping I cannot see [redacted] labels until walking down the aisle. When I'm tired or my eyes feel dry, it's much worse and can last for a constant of several days. I have tried taking more vitamin A, Zinc, Omega 3 and Omega 6, protein, but all have not significantly improved anything. Overall, I wish I never had the surgery. I have all the problems of contacts, but feel that I will never see clearly again for the rest of my life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1834674
Had LASIK surgery in 2008. Now suffer from chronic dry eyes. This condition has caused blurriness and irritation, along with extreme dryness in the eyes. I had to have eye plugs inserted into my eyes to help alleviate some of the dryness from my eyes. At one point I thought I would no longer be able to perform my job due to having extreme eye pain. I now have plugs in my eyes and that seems to be helping to some degree, but I still must use medication on a daily basis and continue to put moisture drops in my eyes during the day to alleviate some of the dryness. I really wish I could go back in time. The doctor never explain any of this to me and told me it was a simple procedure and even encourage me to get it done.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1828643
Event Date 05/01/2010. Had custom intralase LASIK performed on both eyes in May. Since have had severe dry eye, halos, floaters, starbursts, and light sensitivity. I wore contacts for years and my eyes never bothered me before. Now I am in constant pain. I have never had depression before and since LASIK have fallen into a deep depression. My physician downplayed the side effects saying they were uncommon, occuring less than 1% of the time, with the newer lasers and if I had custom LASIK, the change of side effects would be even less.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1823500
I had LASIK surgery on both eyes and immediately had severe dry eyes, halos, ghosting, double vision and headaches. I have spent the past six years with over 11 doctors with minimal relief. In the interim, I developed a cataract in one eye due to steroids used as a potential solution for my problems. The cataract healing process took almost one year and has left my eye in much worse condition. I now am left with only one third of my eye that I can only occasionally see out of properly. This is like a film over my eye that gets much worse with high humidity. My current condition finds me waking 5-6 times per night to 'un-stick' my eyes with specialized eye lubricant. I have found no lubricant that has worked well and am constantly searching for an answer. I am also developing a new pain in my left eye deep within. The reason for this is unk at this point.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1817589
Event Date 01/18/2008. Refractive surgery performed for mild myopia by [redacted] eye institute, [redacted]. Since this procedure, I have experienced severe dry eyes, requiring daily drops and night halos from headlights/street lights that limit evening driving. Sunlight glare is also extremely painful, and I must wear dark sunglasses now. The correction from the surgery reversed almost immediately,- started within 1 week- and according to my optometrist, 2 years later, I have regressed 25% and 40% from [redacted] back to my original prescription. I advised [redacted] from the first exam that I train horses and am in a dusty arena daily, and I drive at night with a 40 ft horse trailer to shows in [redacted]. They said their procedure rarely caused problems. Less than 1% they said, and I was an excellent candidate with little correction. Everything would be fine, and I wouldn't need contacts anymore. It is difficult to train horses with the dust in the arena, and wear contacts or glasses. At my last appointment, in [redacted] 2010, their response was to give me a script for Restasis at a cost [redacted], which I cannot afford, and said only another procedure would correct the halo problems. They said halos are from uncorrected astigmatism. I refused to have my eyes re-corrected again with LASIK in [redacted], and asked for a partial refund. They agreed, but then never followed through, and have ignored all of my written communications with them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1824683
Laser-assisted in-situ keratomileusis -LASIK- surgery was performed on both eyes in 1996, when first approved by the FDA. Since then, I have suffered multiple side effects such as dry eyes, star bursts, diminished night vision resulting in inability to drive at night, loss of LASIK correction, among others. About 10 years ago, both eyes suffered tears and holes in the retina, requiring laser surgery. Since 04/2009, I've undergone two cataract surgeries on my right eye; an initial surgery and repeat surgery to replace the IOL. On [redacted] 2010, I suffered a complete retinal detachment resulting in blindness in the right eye. After emergency surgery in the hospital under general anesthesia, the vision is slowly recovering.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1781740
I want the FDA to know that LASIK has ruined my life. I only wish that the FDA had prevented this before I jumped head first into it. I have tried on numerous occasions to contact people and let them know what kind of business this LASIK surgery has turned into. It is corrupt. I can guarantee that if the true results of a properly done satisfaction survey was done, it cannot be 95%. It would probably be in the 75-80% range. You get no where when you complain about a bad outcome with this surgery, because they can't fix you. What this surgery has turned into is shameful. It falls under a system that I have named "spreading the blame". This is a common political protectant that a lot of corrupt practices use in hospitals, medical practices, and larger firms that are allowing people to get away with wrongdoing. It works like this, everyone is to blame for the wrongdoing, but you can't get your hands around no one to blame. As in LASIK, it was approved by the FDA, laser companies make faulty equipment, doctors are performing it, state medical boards rarely act, and you are caught in the middle crying "help", but there is no police to call to. The FDA doesn't police doctors, state medical boards have regulations they have to follow, laser companies say it's user error, your doctor says it takes time to heal and if you do sue, you signed the consent form before you went in, which leaves you injured and no help available. This is how it works plain and simple. Why do you think that all the injured pts' complaints sound so similar? we call to get help from the FDA who we think are in place to prevent this type of practice, but we continue to get nowhere. Please listen to what I have said.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766925
Had lasik surgery - now see the star bursts, double vision out of one eye, was corrected with an enhancement from triple vision. The lasik surgery has made my vision irrepairable and almost totally debilitating at times. Unless there is perfect light, no fluorescent lighting, i cannot read. Have tried prisms in glasses to reflect lighting and this did not work. The lasik destroyed my vision - it used to be correctable with glasses/contacts - now nothing helps me see. Lasik specialists just shrug their shoulders - oh well.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1657876
I had LASIK procedure performed on [redacted] 2007 on both eyes. I was astigmatic and suffered from myopia. After undergoing topography, my doctor confirmed I was fit to undergo LASIK procedure. Initially, all seemed fine and I was convinced my surgery was a true success. Unfortunately, I started losing vision on my right eye 3 months after the seemingly successful procedure. All along I never missed any appointment with my doctor and he assured me I was fine and need no worry as what I was experiencing was normal and a reflect of my brain. Unfortunately the condition continued to deteriorate and 2 yr after undergoing the procedure, my doctor claimed I suffered from keratokonus. I sought second and third opinion from other specialist and both have concluded I suffer from post-LASIK corneal ectasia. I returned to my doctor who advised me to undergo cornea cross linking in order to stop further progression of ectasia. I believe I am a victim of misinformation and unnecessary surgery which has rendered my right eye technically blind. I am hoping there is a way I can restore my vision to return to normal life. I regret going for the LASIK procedure and believe this technology is not safe and cannot be guaranteed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1662665
Custom wavefront lasik both eyes. Initial outcome: remarkable improvement in vision. Deterioration noted after 3-4 days. Problem with multiple images immediately following procedure, esp. At night. Dry eye. Distinct difference in prescription between left and right eyes after surgery. Right eye was retreated after 9 months and is now near sighted only. Dr. Advised against retreat on left eye -for fear of same outcome?- when i look at the moon or a traffic light i see 5 images. The additional images are in the same positions in both eyes. This leads me to believe something was wrong with the equipment or setup -visx- several wavescans have been attempted by 3 doctors/machines since surgery on the right eye with no success.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1633058
Had lasik eye surgery. Was not aware of the real impact of dry eye syndrome. After 6, doctor said i would recover to 'pre lasik condition'. It's been over a year. My eyes are very, very slightly better. I'm buying [redacted] of drops and lube a year to keep my eyes moist. Every hour i'm putting in a drop because of the pain. Doctor has no response to correct this and does not take accountability. We need to make this more aware and find cause.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1633068
Post lasik dry eye - loss of tear production due to cornea nerve damage. This is a severe dry eye condition and serious and permanently debilitating illness. I suffer every day as a result of this condition. I feel i have been deceived by dr [redacted] and dr [redacted] of the [redacted] eye care institute, [redacted]. They minimized the risks to lasik and are completely unable to fix the problem they created. Lasik permanently damaged my corneal nerves and i am unable to produce tears. This procedure should be removed from the market immediately.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1631819
Laser assisted in-situ keratomileusis - visx customvue customized corneal lasik post-op problems persisting to the present - [redacted] 2010-: -persistent eye pain in left eye -persistent dry eye unrelieved by drops, including restasis -unintended induced monovision from undercorrection of dominant eye. -fluctuating acuity/unstable refraction in both eyes, worse in left eye -persistent light sensitivity in both eyes -ghosting, double vision, monocular diplopia -glare, arcs, starbursts, haloes, night vision problems, nocturnal glare -loss of contrast sensitivity -increased floaters -general misery from eye problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1630776
My left eye had bad cornea scarring and i need a cornea transplant which costs [redacted] that i don't have. I have to close my left eye while i see with my right one or the bad sight overlaps with my right eye. I now have one good eye. And glasses don't help. Contacts hurt after 4 hours in my left eye, so i can't wear them all day. Also my left eye is 20/100 with double vision and very bad light streaks at night. I just want my left eye taken out; it bothers me when i try to see with my other 20/30 right eye. I got laid off two months ago, and it probably will be harder with one eye to keep any decent job. I had four operations -enhancements- that caused trauma to my left eye and started [redacted] simplex which caused damage to my left eye. The place where i had operations will not help me at all with money because they say i can't prove that the lasers caused the virus. I am very mad, but can't do anything about it. By the way, i did not have [redacted] before the operation.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1621611
Lasik surgery, 7-10 years ago unable to fully correct vision corneas too. Didn't know this till after procedure. Had a spontaneous detached retina that required surgery with gas bubble and a second lazer procedure. Still do not have vision in left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1621621
Complications from lasik surgery in 2005. Prior to surgery in 2004, I was diagnosed with an autoimmune disease - thyroid eye disease. I was treated with radiation therapy in 2004 to control inflammation in eyes. I was told I was a candidate for surgery with worse case senario being I may have to wear glasses or contacts to get 20/20 vision. Vision deteriorated over time and I had 2 refloat procedures to try to improve the situation. I had 12 sutures placed in my left eye on the second refloat procedure, to help hold the flap in place. My vision post lasik is 20/200 in my left eye and 20/70 in my right eye. Glasses do not correct the problem and contacts are not an option because I am intolerant to them. I spent 6 months with a lens specialist at the (b) (6) with no success. Due to the lasik surgery, I suffer from vision loss, double vision, halos, irregular astigmatism, anasometropia and dry eye syndrome. I lost my job of 16 years due to the complications.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1621653
In (b) (6) 2004, I underwent the lasik procedure. In 2008, I discovered that I had developed the lasik-related complication known as ectasia -aka, iatrogenic keratoconus or secondary keratoconus-. This has had a significant negative impact on my vision, well-being, and quality of life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1614841
Lasik surgery. Dry eyes, no intermediate vision, history of 2 corneal erosion in right eye post surgery. Stromal puncture to correct. Eyes are very dry. Lasik plus.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1599978
Had lasik surgery on both eyes on the same day. Post-operatively, I have had to have a corneal transplant in one eye and I am legally blind in the other eye. I now need a second cornea transplant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1595170
I had lasik done 5 years ago, i was a -6. 5 in both eyes with astigmatism in one eye. I had worn contact lens for 33 years. I began having difficulty seeing up close, i thought lasik would help me, so i would only have to use glasses for reading. My dr tried to under correct one eye so i could see up close without glasses. I could not adjust to my vision being off, i went back for a redo and did both eyes again to get me to 20/20. I never could see 20/20. At dusk i cannot see, difficult to drive and see in dim light. Halos around light also. If i had realized or read about these problems from others, i would not have had this procedure. My husband had his eyes done at the same time and he has been pleased. I have 4 other children that are near sighted one with a prescription of -12. 5 and -13. 00. I would never encourage any of my children to have this procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1595185
Developed dry-eye syndrome requiring ongoing use of restasis eye drops. Eyes are extremely sensitive to make-up. Distance vision is blurry when my eyes get dry.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1593115
After 11 months. I have dry eye, halos, starburts, pain. I cannot work because of this. I have been to 7 doctors all have different answers and nothing has worked. I am upset with the way lasik is put forth. My doctor made it sound like this stuff will not happen to you it only happens to 1% of the people and you have healthy eyes, so you have nothing to worry about. I told him over and over, i am on a computer all day i cannot have dry eye and he told me it would be short term.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1590946
Had lasik surgery in right eye. I'm almost blind in the "corrected" eye and am told by doctor that the situation is irreversible and will likely get worse.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1588686
No dry eye experienced or diagnosed prior to lasik surgery. Immediate and lasting severe dry eye, with pain, irritation, redness after surgery. Continuous discomfort. Must wear eye goggles to use oven, clothes dryer, must use no fan or heat in car. Must stay out of moving and/or heated air and any dust or smoke, including rooms with a fireplace. No relief from drops, lubricant or steroid, or restasis. No relief from punctal plugs. No eye makeup or lotions can be used anywhere near eyes. Numerous returns to surgeon's office. Seen by another doctor each time. No relief.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1585825
The surgeon reported an over-correction in a pt treated for lasik vision correction. Further pt details have been requested but have not been received. The clinic is reluctant to provide additional info.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1600413
Adverse event: overcorrection. An optometrist reports a patient with an overcorrection following lasik surgery. During a follow-up call with the optometrist who is authorized to speak for the surgeon, it was related that the surgeon did not feel the laser contributed to the reported overcorrection. The log file review discovered the laser technician inadvertently entered the incorrect treatment for this patient. The surgeon stated he did not wish to discuss the matter further.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1600414
Adverse events: induced astigmatism. Decrease in bcva. Malfunction: system error message. A surgeon reported they received a secondary energy error that interrupted a surgical procedure in progress at 29% completion. The system was rebooted to resolve this error. Upon rebooting they then received an error 8: scanner defective message when they tried to arm the laser. The facility rebooted again, but this did not resolve the error when trying to arm. A monthly scanner test was performed and then another reboot was attempted. The issue then resolved and they were able to complete the surgery. Additional information was received. At three weeks following surgery this patient had induced astigmatism in the left eye (reported as an overcorrection of the astigmatic component) and a decrease of six lines of bcva. At this the postoperative refractions are reported as being unstable which could be due to some underlying edema and corneal surface changes; the patient may need some additional time to heal. At 4 weeks post op the bcva improved to 20/30, a 2 line decrease. The surgeon discussed the patient's details with alcon's medical monitor. After discussion of outcome and postoperative stage, the surgeon notified alcon that he felt the patient was not harmed or injured, the decrease in bcva was temporary and he expected the patient to heal.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1600416
Adverse events: induced astigmatism. Decreased bcva. A surgeon reports a pt with an asymmetric lasik treatment in the right eye; the superior part of the corneal ablation seems to be flatter in comparison to the inferior per the pt's topography. The surgeon indicated this pt was not harmed or injured, but wanted to send in pt records for a review and feedback. Pt records were received and reviewed. Pre-operative topography showed some irregularity or symmetry in the topographical profiles. This observation was shared with the surgeon during a f/u discussion. The surgeon acknowledged the pre-operative irregularity, but found that to be normal. The pt also experienced a decrease in bcva and induced astigmatism post-operatively; however, the surgeon again stated there were no concern of harm or injury for this pt, the decrease in bcva was temporary and individual pt response to the treatment may have been a factor in this case. Although requested, no add'l pt records were provided.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1604740
A surgeon reports one patient who is overcorrected in the right eye following lasik surgery and is exhibiting a decrease in bcva. The surgeon stated he doesn't fell the eye is stable yet and will wait to consider a retreatment. The safety and effectiveness of this laser system has not been established for patient's with previous corneal or intraocular surgery. (this would include rk surgery). Additional information has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1584200
I had lasik surgery in (b) (6) 2003. My doctor was (b) (6) in (b) (6). I had halos the first few days, and they slowly went away by the end of the first week. Then after about a month, i started getting halos again. This time, the halos were more like smeared light. In one eye, it is smeared one way, and in the other eye, it is smeared the other way. With both eyes open, all lights look like they have big smeared "x"s over them. Also, when looking at certain kinds of lights, like traffic lights. I see double and triple lights. The visual artifacts kept getting worse for a period of 6 months and then stabilized. I also started seeing large starbursts over bright lights like headlights. To this day i still have severe visual artifacts, especially indoors and at night. During this time, my doctor insisted that my eyes were "perfect". I tried to show him a picture of what i was seeing but he told me that i was exaggerating and said that i was a "perfectionist". He treated my issues as if they were dry eyes and put plugs in my tear ducts at every visit. This did not help with the halos and starbursts; however. I believe this might have made them worse.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1584204
I have debilitating complications from lasik surgery. Severe and constant eye pain, severe dry eye, my eyes now have severe reactions to wind, air, heat or air conditioning, and i can not wear makeup as the dust/fumes create pain and tearing. I am unable to spend prolonged time at a computer screen or read without suffering eye pain. I am unable to work outside the home because of these issues. My life has been changed for the worse due to the surgery. I suffer from fibromyalgia-and did at the time of the surgery-and most like undiagnosed dry eye. The potential complications of the surgery were not made clear, and there was surely not sufficient screening considering my pre-existing conditions. The whole process in the doctor office was unlike a manufacturing production line atmosphere. From the interview to the actual process, it was unlike any other surgery. Very production/through put oriented at all levels.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1584301
Following laser surgery for correction of nearsightedness, pt immediately began to see double when reading or doing other close-up work. A second laser surgery was done on the left eye on (b) (6) 2002, but the double vision problem was not corrected. Pt declined further laser surgeries. Eye tests indicate pt's vision is fine, albeit with some double-sightedness. If the pt reads a book for a while before the eye test, the results are greatly reduced, however, as the double vision in more severe. This double vision is not the result of poor tracking between the two eyes; each eye independently sees double, with the right eye being more extreme. The doctor who did the laser surgery could find no reason for the double vision, although one of his assistants told the pt there was more astigmatism present following the laser surgery than before. Several years later, another doctor said the problem was dry eye and could be corrected with tear duct plugs. Pt allowed temporary plugs to be placed in the tear ducts, but they did not stay long enough to see if there was any benefit. Use of artificial tears does not clear up the double vision. As a result of this complication of the laser surgery, pt has difficulty reading for relatively long periods, and can do so only be gradually squinting more and more at the page and trying to ignore the shadows of the double images.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1580950
Approx three to four months after receiving lasik surgery on my eyes, i developed blepharospasms in both eyes. It took many months and visits to a wide range of doctors, including the doctor who performed the lasik surgery, before the condition was diagnosed. Since then, i have been receiving botox injections every 12 weeks to halt the eye spasms. Without the botox injections, most activities were perilous as i never knew when my eyes would spasm shut and stay shut for many seconds, until i opened them manually.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1580953
Typical event problems getting progressively worse -i. E. Severe dry eyes-. Becoming more difficult to drive without sunglasses in daytime and bad glare, halo, etc. At night. Also, have what was diagnosed as a cataract forming on left eye. Surgery was done (b) (6) 1998, at the (b) (6) eye institute by dr (b) (6) and cost (b) (4). I was told i would have to wear a contact lense in left eye at 1. 50 magnification or wear reading glasses. I wore the soft contact lense for almost one year and then changed to reading glasses and currently, cannot find an eyeglass lense that helps correct what is also needed for distance. Date of last eye exam was (b) (6) 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1580957
I had lasik surgery on one eye. On the second day postop, i developed a condition called diffuse lamellar keratitis. Treatment was started of hourly steroid drops and other eye drops. A few days later, the flap had to be lifted again and the eye flushed out to remove this debris. It is a month later, and i still have the condition greatly affecting my vision. Sometimes impossible to see clearly. This is a much more prominent side effect of lasik than is being reported! it is a dirty little secret that is not disclosed prior to surgery!! this condition has the potential of permanently scarring the cornea and causing blindness. Please investigate and insist all cases must be reported!!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1581149
Lasik surgery: as a result, i have double vision in my upper left and upper right gaze. This was brought to the attention of the doctors at the laurel eye clinic, but i was told double vision was not a result of the lasik surgery. My health care doctor sent me to a neurologist, who sent me to an neuro-ophthalmologist. I had two mri's and was told by the neuro-ophthalmologist the double vision was caused by the lasik surgery. At my last eye appointment, (b) (6) 2010, the upper left gaze double vision is worsening but still, the doctor did not acknowledge it could be from the lasik surgery. He tested me to see if the double vision is progressing and it is. Still, the doctor's only comment about it was, "i understand how frustrating it must be. ".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1581149
Lasik surgery: as a result, i have double vision in my upper left and upper right gaze. This was brought to the attention of the doctors at the laurel eye clinic, but i was told double vision was not a result of the lasik surgery. My health care doctor sent me to a neurologist, who sent me to an neuro-ophthalmologist. I had two mri's and was told by the neuro-ophthalmologist the double vision was caused by the lasik surgery. At my last eye appointment, (b) (6) 2010, the upper left gaze double vision is worsening but still, the doctor did not acknowledge it could be from the lasik surgery. He tested me to see if the double vision is progressing and it is. Still, the doctor's only comment about it was, "i understand how frustrating it must be. ".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578295
I had lasik performed on both eyes by a dr at the facility in 2002. I don't remember the exact date. Since then, i have had an uncomfortably dry eye on the left side, and the vision has deteriorated on the right side to the point where i need glasses for both distant and near vision. We have tried every type of therapy for the dry eye with no success. Before the surgery i told dr that my eyes were too dry for me to wear contact lenses. He performed a tear test and told me that although my eyes were on the dry side of normal, i was a good candidate. That has proved not to be the case. In my opinion, if eyes are too dry for contact lens wear, that should be a serious warning sign that there may be dry eye problems after lasik. If i had to do it over again i would not do lasik. A recent tear test performed by dr shows that the tear production in the right eye is unchanged from prior to surgery, but tear production in the left eye is less than half what it was prior to surgery. In addition, although it's a minor problem, at night i no longer have the very sharp vision had with glasses. Stars do not appear as single dots of light, but have a slight star-burst appearance.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578299
Had lasik surgery in 2001, and i have severe dry eye syndrome and was never told that it could be a side affect of the surgery. I experience dry eyes everyday all year around and especially in the winter cold months and also especially when it is windy. I experience it almost constantly as the air is usually always dry. I have runny eyes constantly and people frequently ask me if i am crying. I use restatis and it is no longer affective. I have to use drops everyday several times a day. And i fear that it will affect my vision as i get older. Had i known that this would be a possibility, i would have never had the surgery. The quality of life has tremendously been affected as i constantly worry about my vision and have to constantly deal with the dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578327
Extreme, chronic dry eyes due to lasik surgery. I use restasis, which has had barely any effect on the condition. I have had my tear drainage ducts permanently cauderized, which also had no effect on the dry eye problem. I wear onion goggles to work and live in misery with dry eyes. I cannot go in public places without living in extreme, miserable discomfort due to dry eyes. Prior to the lasik procedure, i had perfectly normal, moist eyes with no problems associated with dryness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578382
Before intralase lasik procedure: pt is very near sighted at approx -10. 5; prediabetic; boarder-line high blood pressure, beginning stages of cortical cataracts, full blown rosacea on nose, and very thin cornea of which the pt was not informed of and the lasik would be a one shot deal with no correction possible. Vision is correctable to 20/20 with glasses. Pt has eye sensitivity issues with hard contacts. After intralase lasik procedure in 2005: any correction is now not possible without predisposing pt to ectasia, due to thin cornea; rosacea now spread to both eyes; vision is correctable to 20/20 but must wear glasses and gas permeable hard contacts concurrently or at the same time. Pt has 20/20 with both glasses and gas permeable hard contacts on, both still has multiple visions on both eyes, approx 5 visions per eye with corrected lenses. Pt has high order irregular astigmatism that cannot be fully corrected, so the pt can never see clearly at any distance with corrected lenses due to overlapping multiple images with would be about 10 images for this pt. Pt has constant dry eyes, has light contrast sensitivity issues, starburst light issues at night, and due to pt sensitivity issue to wearing contacts; pt can only wear contacts less than half of the time due to chronic bloody red eyes or infections caused by the contacts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578385
Fifteen years after undergoing corrective eye surgery at hospital, in the excimer laser program, i've developed severe dry eye, light sensitivity and a constant burning sensation in both eyes. Doctors have informed me these symptoms are likely a result of the procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578387
I had a lasik procedure done 10 years ago because i have myopia and could not wear contacts any longer due to dry eyes. Since the procedure, i have had decreased visual acuity, redness, dryness and irritation of the eyes. I am now under the care of a cornea specialist and use serum derived eye drops that require refrigeration 4 times daily. My distance vision is 20/25 now, and a use a variety of glasses for presbyopia. At the time of my surgery, i was not informed that a side effect of lasik may be increased corneal dryness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578390
I had lasik surgery to correct my distance vision. I had perfect reading vision. I wanted to no longer need contacts or glasses while i was out walking or driving. The surgery seemed to go smoothly, but i have had excessive dry eye problems as well as night vision halo problems when driving, and i need reading glasses all the time. My eyes also tear up and run down my face if i step into cold weather. I must use lubricating eye drops all the time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1578403
I had lasik surgery in both eyes in 2002 at the eye clinic. All went well and i had no problems until 2008. My right eye got very blurry- very quickly. I thought it was time for me to go in and have lasik again- or a "tune-up" as they call it. I went to a new doctor because i had moved. He spent a lot of time and took a lot of fancy pictures and said that he thought i had "corneal ectasia". He sent me to a cornea specialist at another facility for a second opinion. The cornea specialist agreed and diagnose me with corneal ectasia. Both drs said this is caused from the lasik surgery. Dr recommended a clinical trial at the third facility - a crosslinking study for this very diagnosis. I am at this time enrolling in it. I am very concerned though because it is a study and not a treatment. The vision in my left eye is very bad, but there is nothing to improve it at the moment. And i have to travel to atlanta and must pay for all of this on my own.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1577588
I underwent lasik eye surgery in 2006. Since the surgery, i have suffered from a number of severe complications, and my vision is now permanently damaged. My vision problems, since the surgery, none of which were pre-existing include double vision, halos and starbursts on any light source in a low-light situation, significantly reduced contrast sensitivity - especially in low-light situations-, and chronic headaches from eye strain. The surgery was performed by a dr. Follow-up surgeries were performed on each eye in a failed attempt to correct my problems. After dealing with these issues for two years, i was instructed by the doctor to simply wait for them to clear up, which still hasn't happened -it's now been more than four years since the original surgery-. I finally gave up on trying to convince dr and his staff that i had significant vision problems; they seemed convinced that it was either all in my head or something that would resolve itself eventually.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1577576
I am reporting the negative results of lasik surgery on my eyes. Immediately following the surgery, i experienced a precipitous loss of "near vision", i. E. The ability to see objects close to me. The radius of my lost "near vision" has continued to grow over the past three + years and now extends to approx four feet from my face. I have no genetic history that would explain the sudden and continued loss of my reading vision. Additionally, i now experience frequent headaches from the constant effort of trying to focus my eyes from near to distant objects. I experience mild discomfort in my right eye periodically, as if an eyelash was in my eye. Most disturbing to me is the damage to my peripheral vision: if i look at something out of the corners of my eyes, i experience severe double vision and dizziness. This was not something i had prior to lasik surgery, but presented immediately following the surgery. Finally, after all the expense and side-effects of lasik, the astigmatism i had sought to correct was not corrected and the benefit of improved distance vision has dissipated over time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1570798
I had a lasik surgery in 2005. I had -5. 75 in left eye. After that, for 2 years, i had a good vision and no pain but dryness. I had to put two drops of lubricating 4-5 times a day. But in 2008, when i put genteal lubricating drops, i got some allergy or infection in my eyes. I got it treated through putting "anti oxidants" -tetracycline hydrocloride- drops for some 5-6 days. But this created a tightening of ligaments, muscle spasms and constant pain in the nerves beneath my left eye. I could not now put lubricating drops, due to this besides having dryness. Putting drops would create additional pain in the nerves and stretch the nerves. Working on computers and travelling outside is still next to impossible. This has got me nightmares and totally hampered my confidence. The pain below the left eye has still not subsided. There is still consistent pain in muscle tissues and veins. It becomes too difficult to tolerate. I could not understand what the problem is? even in night time, i can feel the pressure-weight- in my veins and constant stretch of veins which causes me immense pain in sleeping. I change my lubricants and sometimes, i feel a little subsiding of the pain. But after continuing for some more time, it again emerges. The eyes are not red. I tried vitamin medicine for veins-. I felt better with it, but only for 3 days. Afterwards, it again re emerged. Also, i have now stopped all lubricants but the pain does not subside. When i work on computers, the pain increases a lot. That's why i have to compulsorily take betnesol-steroid. I had consulted ophthalmologists, neurologists, also conducted an mri but got no results. They say there is no problems in my eyes. I have started doing yoga-pranayam for 3 months but i get freshness-and no pain relief. I have stopped betnesol and all lubricants in my eyes. But now i have increased floaters in my left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1569406
The intralase fs laser was used to create bilateral corneal flap(s) for lasik surgery in 2009. During the surgery, the patient presented with opaque bubble layer (obl). The surgeon reported that because of the obl it was difficult to separate the flap. In order to complete the excimer treatment, the surgeon massaged the cornea very intensive in order to get rid of the obl. Two (2) days post-operatively, the patient presented with diffuse lamellar keratitis (dlk) on both (ou) eyes. A flap lift and rinse was performed ou and the patient was treated with topical steroids. A bandage contact lens (blc) was placed on the right (od) eye after surgery for one day. The patient's preoperative best corrected visual acuity (bcva) was 1. 0 od and 1. 25 for the left (os) eye. Patient's postoperative bcva is. 7 od and. 8 os. As of the following month, the patient's dlk had not resolved, the patient was still not satisfied.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1527201
I had lasik in 2006 and since the surgery, I continue to have dry eyes, and occasionally my eyes are red almost look like the pink eye. I recently was diagnosed with corneal erosion of the eye flap and was instructed by my eye doctor to return to the lasik doctor for further treatment. The physician at the lasik facility stated that it was a small erosion and I should not be worried and to follow-up in 3 months. The redness occurred a few years ago, and I did not know why and now I do. Lasik plus.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1523467
Halos, double vision, slow vision. After lasik surgery was performed I began seeing halos and experiencing double vision after dark. Although follow up tests have rated my vision as 20/20 or 20/25, it sometimes takes several seconds to determine the answer when I take the vision test. Although I can see well, these vision issues are noticeable at night. These symptoms -slow vision, double vision, and halos- are only a problem in one eye. I manage by closing that eye when needed or wearing an eye patch when needed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1522969
I had lasik performed in 2006, and had 20/20 vision, but within a year, I had 20/50 in my right eye and I asked for them to perform lasik again in my right eye, which they did the following year. Right after the first surgery, for that 15 months, I had slight dry eye, but really no problems. All the problems began after they performed the second surgery. Since then I have had severe dry eye -i take restatis and lotomox twice a day- and in 2008, the doctor scraped extra epithelial cells from my right lens since they had not stopped growing where the cut had been made in the lens. I am still having this problem and the doctor thinks I might have to go in and have the cells scraped again, but I am not looking forward to it. Sometimes the pain is so intense from the dry eyes that I cannot see well, my vision is 20/30 and I am constantly using systane to drop my eyes. I have a very good doctor, and I know that he wants to do what is best for me, but my eyes are just not responding the way they thought they would. If I had known that this is what I would have to live with for the rest of my life, I would have just kept my glasses - I am so upset at my own vanity for having elected to have this done - but if there are more people out there like me, may be something could be done to make people more aware of the possible problems with lasik - it is a hell of a lot more than "may be a few months of dry eyes" which they told me would be the worse thing to happen after lasik. " lasik surgery on left and right eyes - 2006. Lasik surgery on right eye - 2007. Removal of epithelial cells on right eye - 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1522305
Complications from Intralase/wavefront lasik. Constant eyestrain, light sensitivity, loss of contrast sensitivity, eye pain, decreased quality of vision despite being "20/20". Upset about the type of advertising and lack of objectiveness of doctors in this area. Would love to see a mandatory unbiased second opinion for anyone considering lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1520339
I had lasik in 2003 and am having burning, itching, grit in the eye sensation and pain in my eyes [they actually ache sometimes], which seems to be getting worse. I can see alright, but I am constantly putting drops in my eyes to alleviate symptoms; drops work about 50-75% of the time. I do have allergies, and sometimes I don't know if its my allergies or just dryness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1520327
When lasik surgery is performed and an excellent result occurs somewhere down the line the pt will develop cataracts. Currently the implant target error ratio is about 96% accurate for people who have not had lasik. When they do have lasik their implant target error ratio goes down to 80% accuracy if all corneal tissue loss is accounted for as well as refractive error caused by the cataract is understood. All pts need to have their preoperative keratometer readings, preoperative refractions and their post op info 3-6 months after laser once the eye has stabilized. This is also true for pts who have had radial keratometry surgery as well. There are needs to be a public alert to get these records so that they are not destroyed. Currently I think after 7 years they are destroyed. Please encourage lasik pts to get this info to aide in their future need for cataract surgery as you put this study together! If they have lasik surgery in their 20's, 30's or 40's they could be at higher risk of needed further lasik surgery or intraocular lens exchanges following the cataract procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1532019
I had a lot of eye surgeries starting in 1991 with rk then laser and continued on with lasik first in 2003 in both eyes and then repeated again in 2005. This caused unstable corneas and also led to having a corneal transplant on the right eye they said due to scarring. I also now have fluctuating corneas from the lasik and can't get good vision. We have tried hard contacts but can't tolerate due to dry eye because of the lasik. I have not have a problem with the transplant other than not getting good vision. I have been told as recent as 8 months ago that I could have the left eye transplant done whenever I was ready, which is insane since my eye sight is worst in the right eye than the left even though nobody understands how I can see thru all the scarring. I have also had cataract surgery on both eyes due to early development probably due to excessive use of the steroid drops for all the eye surgeries. I have been living with this for 18 years and no doctor can help but to tell me about the new procedures on the horizon. My best corrected vision fluctuates between 20/60 and 20/100.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1517747
Lasik surgery. No specific adverse event date. See info contained herein. Ghosting. After lasik surgery, eyesight was about 20/20 and 20/30, ghosting double in one eye and ghosting triple in the other. Ghosting was not disclosed as a potential side effect, and I never even heard that term until I read a article published after my surgery. -surgery was in 2001, I believe. Regression. Within about six months, my eyesight had regressed to about 20-80 and 20-200, and has continued to regress. Regression was never disclosed as a potential problem/side effect. Dry eye syndrome. An optometrist inserted punctal plugs and lutien supplements were taken. While the goal was to leave enough cornea for an enhancement, the post-lasik corneas were judged to be too steep for an enhancement. Furthermore, a second surgery probably would result in regression, leaving even thinner, dryer corneas. Treatment for dry eyes did not increase corneal thickness enough for an enhancement. Today, I use contact lenses to correct myopia and astigmatism; they are multi-focal lenses. I cannot use the contact lenses that are hard-centered and soft-rimmed, since they inflamed the lasik-rim on my cornea. Currently, eyesight is not completely corrected, and there are halos/starbursts and ghosting with contact lenses. The lasik surgeon was one of the most-experienced and most-recommended lasik surgeons. He was one of the original 13 fda researchers for lasik. Dates of use: 2001. Diagnosis: myopia; astigmatism. Lasik surgery, date was 2001, I will give permission to obtain post-surgery info from ophthalmologist and optometrists if it helps folks in the future.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1517753
A dr has botched my lasik procedure resulting in two difference injuries. He has also falsified my medical records via change in dates and omission of info, in order to falsify the order of events and his subsequent culpability for the injury-s-. Dr left a fold in the flap of my right eye, resulting in a vertical "crease" in my vision, and pressure in my right eye. He either did not have the proper equipment, or did not know how to use the equipment to perform a flap lift and re-set, in order to remove the fold. I suspect that he does not know how to do a flap lift/stretch and re-set, because he does not schedule one-day-after appointments for his lasik patients -he performs lasik on fridays, with follow-up the following week at approx day 4-. Dr also does not know how to properly assess flap folds, because he severely under-estimated the injury in his notes. After his apathetic, regarding my poor visual quality, and my numerous complains, he finally referred me to another facility, where my injury required a flap lift and suture at 7 weeks post-op. Immediately before my appointment, dr abruptly cancelled my appointment and "dismissed" me form his office -those are the terms his office personnel uses-, therefore, I have not seen dr since 2008. Dr carved my eyes each to see something different; which has permanently impaired my binocular vision. Ghosting exists in both eyes, with light spraying outward to the left in my left eye, and to the right in my right eye. Note that the prescription appears correct, however, the carving / curvature of my corneas is obviously wrong, resulting in extreme distortion in my vision. Corrective measures attempted: I have attempted a glasses prescription to correct this error -did not work. Another dr, is reluctant to do anything else, because I am able to read the eye chart -prescription correct, visual quality. Dr(third), is suggesting catz prk, which is currently not fda approved, and only available outside the u. S. Is there a problem with this laser. Why is it being used incorrectly? dose or amount: not known, frequency: not known, route: unk. Diagnosis or reason for use: lasik in 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1517750
Lasik procedure exams on both eyes in 2002. I needed glasses as I could not see anything well -road signs etc- distances. I decided to check out the lasik procedure. I was told that I would love the outcome, etc. I was told that my near perfect close up sight may be affected but that would happen as I grow older anyway. Although immediately I could see very well distances, my up close vision was bad. When I went to follow up I was told that it would get better and better. My up close vision is horrible! I am now experiencing headaches; extreme difficulty seeing anything up close, need "readers" continuously. I experience moderate to severe dry eye, itching, burning and redness daily.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1516911
I had lasik surgery performed in the year of 2000 at the age of 51. It took an entire year for my eyes to truly settle in to their new vision. The past summer, I have been diagnosed with dry macular degeneration and very small cataracts. I have very blurred vision. Macular degeneration does not run in my large family and only my mother has had cataracts -she had surgery on them this past summer-. I have extreme dry eye in the mornings and have had morning dry eye ever since my lasik surgery. Now that I have to wear gas perm contacts, the dry eye in the mornings is really bad. With an almost negative family history of cataracts and a negative family history of macular degeneration, I can't help but wonder if the lasik surgery has anything to do with these problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515841
Extreme dry eye - often unable to open eyes in morning without excruciating pain. Dose or amount: unknown. Dates of use: 2007 - 2008. Diagnosis or reason for use: reduce dependency on glasses/contact lense for left. Event abated after use stopped or dose reduced?: no. Unknown laser used to perform epilasik treatment; left eye treated in 2007, right eye treated in 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515936
I had lasik in both eyes in 2006. Was told by my doctor I was a candidate and that I would be fine. I was lied to after I came out seeing like a freak, that it was just overcorrection, however, my world was messed up looking, I was walking on a crooked floor, people's faces looked liked stretched trolls, and the walls were falling on me. I was scared to death, and after 2nd opinion, meaning about 10 opinions, and yelled at, and treated like crap, etc. Etc. I finally learned that I was permanently damaged and there was no help for me. This no quality life and since that time, I've met so many and heard of so many people's lives who have been ruined like mine. I see a ghostly lines around all people and all things day and night. It's a freak world. You need to stop lasik. Everyone "i" who had it and came through fine initially are now having problems. Can't see at night, increased starbursts and halos -of course I still have those day and night, too- and some who had to have corneal transplants and now are blind in that eye. You would have not idea how hard it is to live life scared about the world you are in every day. On top of that, I am very upset to see that no communication is made between doctors, because there is less than a handful that at least care enough to work diligently in making special contacts to at least help a person. All other doctors say, nope, can't do a thing, and just turn you out to nothing, but maybe their friend who's a corneal specialist just so he can take your money, too. Knowing they can't do anything, but surely can see you to take your money. This entire lasik is money driven and that is sinful, in my opinion, because it hurts every pt, if not now, later. My life has been ruined by lasik. Getting up every day is not the same joy it was before lasik and is a struggle. They advertise lasik like you're getting your hair cut. Go in, come out seeing perfect. That's how it was presented to me, and they still have commercials on tv saying the same thing. You need to stop lasik. This is a lifelong disability that has robbed me of the joy and beatuy of this world and my surroundings, including my home and family and friends, of which I will never see normal again.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515363
I had the lasik surgery one year and a half ago, I'm suffering from dry eyes, problem seeing especially at night too; sensitive eyes, and pain in my eyes day and night. My vision changed within a year from 20/20, now I have incorrect vision, I need glasses again. I do not recommend this surgery to anybody. I never had any kind of problem with my eyes before, except I had to were glasses while I was driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515363
I had the lasik surgery one year and a half ago, i'm suffering from dry eyes, problem seeing especially at night too; sensitive eyes, and pain in my eyes day and night. My vision changed within a year from 20/20, now i have incorrect vision, i need glasses again. I do not recommend this surgery to anybody. I never had any kind of problem with my eyes before, except i had to were glasses while i was driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515386
A family member of mine has had the corrective laser eye surgery in both of her eyes. Since the surgery, her main eye doctor has removed her from that doctor's care and she is unable to see at night well enough to drive.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1515390
Visx excimer laser was used, had lasik eye surgery performed using the "wavefront" technology -an upsell- on both eyes. Six months later, the surgery was redone on the right eye which needed a "touch up". The warranty on the service was 1 year. After 14 months, i was told that the surgery was a failure and that i would continue to need glasses. This came after enough "follow-up" visits to get me outside the warranty period even though the prescription never got any better or worse. More importantly, i have suffered a massive drying of the eyes since the surgery in both eyes. The dryness gets to the point of making my eyes blurry later in the night and no type of eyedrops or punctal plugs have been able to satisfy the issue.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514212
Lasik surgery = very bad halos, can't drive at night need to take drops to help, problems with glare.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514216
In 2005 i decided to have lasik due to bad vision, -5. 25 contacts. I went to Premier Eye Care in Harrisburg PA for the surgery because, they were my regular eye doctor as well. After all the tests, the surgeon said my eyes were fine to have lasik on. I started to get a little nervous before the surgery and looked on line about lasik and saw the problems people were having with it due to their eyes dialating larger than a certain size, of which mine dialated larger than that size. I went to the surgery and talked to the surgeon before the surgery and she assured me that she has done a lot of these lasik procedures on people with eyes like mine and no one has had problems yet. With her assurance i got the surgery. After it, i remember going to my cousins house and the christmas tree looked "hairy", which they told me was going to be normal. Well almost 4 years after the surgery lights still have "bursts" and "halos" around them. For an example of how bad it is, when walking down the street and cars are driving towards me and someone is walking towards me the cars head lights and the bursts and halos block out the persons face until they are pretty close. Almost all lights have this effect when in the dark and the effect is worse during dusk hours. When talking to my eye doctor, not the surgeon, he told me that they should have never done the surgery on me. Why this was not told to me before the surgery, i have no idea. When speaking to the surgeon about my problems during the 6 month check up, she gave me.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514218
Lasik eye surgery. Now have blurred vision, halos, dry eyes. Vision is rapidly deteriorating. Was advised to watch for lightning as this would mean a ripped retina.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514220
Complications following lasik eye surgery. Have ghosting images in left eye and 2 enhancement surgeries did not resolve ghosting problem. Also very poor night vision, halos and dry eyes since surgery. Vision quality has also regressed since surgery and now corrective rgp contact lenses are the only corrective lenses that help improve my vision impairments since the lasik surgery. Regular eye glasses do not work to correct my vision due to the changes made to my corneas following the lasik surgery. Complications have led to periods of depression and quality of life has declined due to vision impairments since the lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514226
I had lasik surgery. Since the surgery, i have suffered from severe dry and itchy eyes which i never had before. Night driving is also more difficult. Also, right after the surgery i needed reading glasses. I am so unhappy i had it done. People should be warned about the lifelong effects of lasik, dry eyes and itching, and difficult night driving. I am so sorry i had it done. Wish i could go back in time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514227
Had lasik and since then have issues with a halo affect around car headlights for example.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1514237
Underwent lasik eye surgery for myopia. Poor outcome at 9 months post-op. Still extremely bad dry eyes, surgery induced posterior vitreous detachments in both eyes resulting in many terrible eye floaters. Poor and limited night vision, cannot drive anymore at night and limited in daytime. Halo, and blurry vision at night. Poor outcome, left eye not done properly, now left with astigmatism in left eye. At 9 months post-op, no progress, now out of work due to severe and constant eye pain and blurry vision. Surgery performed by a dr at eye center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513524
Lasik surgery performed. Side effects that i have lived with for 11 years have been halos around any light at night and dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513525
I had lasik eye surgery in 2003, enhancement surgery in the right eye in 2005. I had epithelial cell ingrowth in the right eye after the enhancement surgery. I had a third surgery in the right eye in 2006. I have been left with blurred vision, ghosting, double vision, halos in the right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513519
Lasik surgery in both eyes to correct vision of -7. 0/-7. 5. Results : severe dry eye, pain and infection that would not clear. Required 3 rounds of antibiotic eye drops. Correction regressed 1. 5 diopters in both eyes by 3 months. Left eye retreated for a "monovision" correction. This cleared up the stubborn infection suspicion that the original surgery in left eye -with a torn flap, abrasion- had somehow caused bacteria to enter eye or another foreign object was left under the flap- no more infections. Ten more years of headaches, dry eye, increased allergic conjunctivitis, vision correction fluctuations and correction regression toward increased myopia. The "monovision" correction prompted headaches ad fusion problems. Since glasses have been required for vision since 3 months after the surgery, the fusion problem is corrected with glasses. However, since the correction fluctuates and regresses, new glasses were required every few months in the first 5 years. Currently, i switch back and forth between glasses prescription approx. 4 times a year. I have not had a consistent correction in 10 years.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513493
Received lasik, about 4 years later, blurry vision returned. I now wear glasses again.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513495
I read that the fda is investigating the side effects of lasik. I had a congenital crossed eye that was corrected by surgery. Immediately after the lasik, i noticed that my eye began to cross again. My specialist told me this is not uncommon after lasik as the procedure affects the neurological pathways between the eye and the brain. I was never warned that a recurrence of the crossed eye was a possible side effect of lasik. I had to undergo another surgery to correct the crossed eye. I feel that other pts with a similar history of this condition should be warned of this potential side effect.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513496
After lasik eye surgery, my vision is not fully correctable - with glasses or contact lenses, and my eyes are exceptionally dry. Lasik - 2007 and 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513497
I had lasik surgery. Immediately following the surgery, both eye flaps dislocated requiring a 2nd surgery to put back in place and suture them. For the past couple of years, my vision has been declining and i began seeking a solution in 2008. I was informed my corneas were severly "misshappen", i had extreme dry eyes, scar tissue on the corneas and cataracts on both eyes all resulting in very blurred vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513500
I had lasik surgery at lasik plus. I have permanent eye damage and discomfort as a result. I just want to make sure this is recorded in any fact finding reports on the effects of lasik surgery, so consumers will be better informed of the percentage of complications. There needs to be an easy way for pts to report problems due to this surgery, and i think lasik doctors and centers should be required to provide annual reports and records of poor outcomes. Have been receiving medical treatment since lasik surgery date.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513501
Had lasik surgery perform on right eye to remove haze from cornea lens due to minor eye injury. Doctor recommended exzimer procedure would greatly improve vision. Two years later i'm left with results as follows -right eye has lost contact with brain to function together with other eye, right eye wonders, left eye copies right eye behavior due to optic nerves in the back of the brain, right eye is dominate. Due to lasik, i now see double vision, halos around objects at night and i can't not read small print because my eye won't focus correctly. My life has been a living hell due to this surgery. I have fallen down and cut open my face due to equilibrium being off when walking. Also another time, i lost my balance and landed on my nose and broke it. Ending results is pay extreme attention to every move i make, more so now then ever before, such as reaching, bending, grabbing, walking, driving, basically every move i make. I never had these problems as i have medical record from eye check ups to prove that lasik works for some but not all, hope this helps with investigation. I now wear contact lense to help with my issues to this very date 2009. With out contacts, i couldn't type this message. Thank you for your time f. D. A. First time posting on thie site, hope it helps.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513504
I had lasik twice through a dr. My vision is terrible, blurred, cannot see after the sun goes down, unable to drive at night.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513505
Had lasik eye surgery done. I am suffering with a haze, double vision and am unable to drive and having a very hard time going to work. I saw that the fda was looking into lasik surgery on the television today. An employee in the office where i went informed me that at least three people have problems that had lasik surgery on the same day as myself. At this point, i am very concerned and in the process of making a new appointment to have a second opinion.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513526
Lasik surgery in 2008, extreme adverse effect. One of approx 15 nationwide pts ever to develop ctk (central toxic keratopathy). Was further treated on several occasions at the hospital. Extreme: double vision, halos at night, dry eyes. (understand fda is doing large study on this).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513527
I had lasik surgery nine years ago performed by a dr. At first it was great, i could see 20/20 if not better. However, i never felt comfortable driving at night because as a result of the surgery, i had difficulties with white signs appearing very blurry, as well as the halos and so forth. After three years, i required glasses to drive. My prescription has continued to increase, requiring me to where glasses all the time. In addition, i do not drive at night, even with the glasses, unless extremely necessary. I can not see at night - it's terrible-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513528
I had lasik surgery four years ago. I have for the last year had a lot of problems with my vision. My left eye now has a thick layer of cells that are bumpy on the back of the cornea. I cannot drive at night, as the halo effect and brightness of the lights causes severe pain. The eye doctor says there is no health problem that he can find. I also have one pupil now larger than the other and the pupil goes to the outer edge of the lasik scar, so i see the blur line from it. If i had known any of this was possible i would have never had it done. I think people should be warned.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513529
I had lasik surgery in 2004. There were complications which have left me not only with worse vision, but also double, blurred and severe dry eyes. I know also have both near and far sightedness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513530
In 2004, i had lasik eye. The surgery never completely worked and left me with dry eyes, cornea scaring, cataracts, and a detached retina, which was due to the thinning of my retina during lasik. I also had a temporary cornea edema. Per my current ophthalmologist, these were all side effects of the surgery, something my original doctor never told me could result from the surgery. These factors have left me with limited and impaired vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513537
Permanent blurred vision and dry eye, due to lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513544
Following lasik surgery, i have continued to be plagued by very severe dry eye syndrome to the point of disability. Severe associated pain, with occasional mild loss of vision or diplopia.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1513545
I was under educated about the lasik procedure and now have severe dry eye that is not getting better as well as horrible night vision that makes it so that i do not feel safe driving a car at night. Date of use: 2009. Diagnosis: myopia, astigmatism.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1512190
Dry eye several years after lasik surgery. Plus, i have had halos around lights at night and especially when driving at night. Today, i read the fda plans to study the post-operative effects of lasik surgery. So, i thought i would add my adverse events after having the procedure about 10 years ago.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1510242
Pt was told he was the perfect candidate when he first had lasik in 1999 followed by five surface ablation "tune ups" using prk on his right eye. Ultimately the pt required a corneal transplant in his right eye because of ectasia. The transplant surgery was performed by a world renowned refractive surgeon, yet the pt's results were less than adequate and he was enhanced twice in his transplant eye via lasik without improvement in vision. Pt also developed ectasia in his left eye and was treated in that eye with a corneal transplant as well. In 2007, pt was told in consultation with another renowned refractive surgeon that his vision could be fixed with intacs, but this was not the case, and the intac surgeries have left him even more visually impaired. Currently the pt has fluctuating vision on a daily basis with unaided acuity of 20/800. He is unable to see road signs and cannot drive either in the day or at night. Pt has profound night time visual disturbances of starbursts, glare and haloes. Pt had no prior history of depression, yet became suicidal with his outcome. Multiple attempts at rehabilitation with rigid lenses have been unsuccessful because of dry eye and pt discomfort. Pt remains unable to work. Pt now expresses considerable regret that he allowed his surgeon to "talk him into" having lasik performed over a donor graft.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1503667
Severe dry eye - since undergoing lasik in 2005, i have been afflicted with severe dry eye. The dry eye has ruined my life, and limits me from partaking in many activities that i used to be able to enjoy effortlessly pre-lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1501186
In 2008, i had lasik vision correction in both eyes for nearsightedness. Neither eye was properly corrected from 20/400 to 20/100. The left eye was corrected from 20/400 to 20/60. In 2008, i had the right eye corrected a second time, and it is now 20/40. In 2009, i had the left eye corrected a second time and it is now 20/15. Prior to, and during the whole procedure, i explained to the doctors that i was using flonase for allergies. They kept telling me to quit using eye drops for dry eye, as my eyes would not return to normal unless i did. During my last visit they finally listened, and advised that flonase was causing the dry eye, and that i should start using eye drops on a regular basis to counteract the problem. I have lost most of my near vision as a result of this procedure. If the doctor had listened to me at the outset, and not advised me to quit using eye drops, i believe i would not had had the 4th procedure, and would still have my near vision. Please, use this info to inform others. Dates of use: 2008 - 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1490758
Despite repeated assurances that i was a "perfect" candidate for lasik via a custom wavefront "allegretto" laser, i still suffer from large starbursts and glare. The doctor and his assistants swore that i would not have these issues, yet here i am. We need the government to rein in these abuses and help people make informed choices based not on profit, but sound medicine. I had a multitude of tests and was promised this wouldn't happen with the allegretto laser. Dates of use: 2009. Diagnosis or reason for use: nearsighted. As a pt i do not know the model number of the machine - i only know it is an "allegretto wave front" laser.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1490746
I can not stand this life of suffering caused by lasik surgery. Dry eye and ocular pain causes me unable to read or write. I lost my studies and work because i am no longer able to work. My life is very difficult. Please help!!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1490841
A report was received from fda from a lasik patient, reporting the following experience: "since childhood i've had severe myopia. Without the use of glasses, i could not see well more than a few inches away. Know this, my ophthalmologist recommended i be evaluated for a study using laser surgery to correct my myopia. After very thorough examinations and testing, i was deemed a good candidate for the study. In 1994, i underwent successful excimer laser photocoagulation on my right eye. In 1995, i underwent the same procedure on my left eye (which had a refractory of -8. 5 diopters). This resulted in an accidental overcorrection, leading to scarring and compromised my vision. To work, i had to wear special glasses and use lights, which lead to incapacitating headaches. A repeat procedure performed in 1996, did not improve my vision. In early 2007, i applied for disability due to my visual changes and headaches. While in process of applying, i have been examined by several doctors and undergone dozens of tests. I've also obtained all of my medical records including those from the study. " "during this process, as i researched and obtained more data, i became aware these procedures had been performed pre fda standards. The fda reports i found state lasers have not been shown safe and effective for several nearsightedness (more that -7 diopters). The fda also reports that unapproved lasers could potentially cause severe eye injury. Quoting other sources (complications of laser keratomileusis with excimer laser) correction of more than 6. 0 - 7. 0 diopters should be considered a relative contraindication for prk at this time. - eyes like mine".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1485222
In 2005, dr performed lasik refractive surgery on me. In 2008, I started having problems with loss of vision. After going to five different doctors, I was finally diagnosed with corneal ectasia, caused by lasik surgery in 2009. By this time my vision was deteriorating rapidly. Not only is my vision worse, than it was when I received the surgery, but I now experience double vision, ghosting, halos, glare and chronic dry eye. A lawyer suggested I get my medical records from the initial facility. After having the records reviewed, I was told, I was not a good candidate for the surgery. The dr. not only performed the surgery, he falsified the records to show my cornea thickness was 255 mic for both eyes. During this time 250 mic was the standard measurement of cornea thickness allowed, even though most surgeons were using 300 mic as the standard. His records show my corneas were 255 mic thick, but if you read his notes, the thickness in both eyes are clearly under the standard of 250 mic. This indicates to me, he clearly and knowingly put my vision at risk. I will be quite honest with you. My quality of life has been ruined. I no longer can drive, work, and enjoy the things I loved so much, like reading, photography, cooking and so many other things. I am a prisoner in my home and have a hard time doing simple tasks. Contact lenses have not been an option for me and I will eventually have to have a cornea transplant. As I stated, I am unable to work and have no insurance. Therefore, this has not only cause a great hardship for myself, but my family as well. Because the malpractice laws in the state protect the doctors and not the patients, I am unable to sue him at this time. It was one thing to think the dr. had made mistake, but to find out he had put me at risk deliberately was almost more than I can take. I am hoping you can prevent him from doing this to another patient and ruining another life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1132777
I am blind as a result of this procedure. I have no peripheral vision and there is an aura or some kink of colored light around every object that i am able to see. My eyes are extremely dry and swollen. My vision will never be restored. This is horrible.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1474456
It has been over a year and i suffer from dry eye and halos from my lasik surgery. I was told that those two issues were no longer a concern and only happened to early pts of the surgery. After the surgery, i feel that my doctor was dismissive of the fact that i had dry eye. I have plugs and am using restasis and still have to use a lot of refresh eye drops as my eyes are still dry. It really has changed my life for the worse.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1467800
Loss of nighttime vision, dry eyes limiting quality of life, reduced capacity to perform job.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1456919
Lasik surgery left me with permanent problems, many as a result of induced higher order aberrations. I have visual disturbances including inability to see clearly in anything but the brightest light, images from one eye are smaller than that from the other, eye strain, sense of visual disjointedness as the two eyes are different, great trouble reading as the letters seem to vibrate and are too close together, can't see letters on colored backgrounds, etc - and all this with 20/20 vision!! glasses do not help. I was also left farsighted, whereas before the surgery, i was nearsighted.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1449404
Event Description
The surgeon reported experiencing sporadic slight decentration in patients following laser vision correction and approximately 10% of all patients are undercorrected, due to corneal haze. The number of patients and the severity of the outcomes were not provided.
Manufacturer Narrative
The equipment was examined and tested by an amo clinical development specialist at the clinic location. The excimer laser, wavescan and femtosecond laser were found to be operating properly. The cause of doctor's report of random haze was not able to be determined.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1437311
I had lasik surgery performed in the year 2000. I had many problems right after my surgery, i called and saw the dr. Well, he was never available. I saw his assistant, or talked to other staff at the office. Dry eyes, i came to realize later were causing a lot of my problems. I had halos, ghosting and i still don't really like to drive at night because it doesn't feel safe. My eyes are blurry everyday. It starts from the time i get up until about 11am and eases up a little. My eyes have gotten worse over the years, it affects my vision terribly and causes pain, i've spent a lot of money on dr's visits, eye drops, different eye wear, flax seed, omega 3's and many other things. I have been back to him and he says there is nothing he can do except an enhancement -spend more money- well after what i've gone through, i would be pretty scared. My eyes get heavy easily, red, scratchy and gritty. I had none of these experiences before my surgery. This has caused major low self esteem and problems in my daily life with work, driving and other activities.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1434840
Had lasik surgery in 2007. Immediately had dry eyes so bad that could not open them in the morning. Night time dry eyes still exists. Right eye was over corrected and now have lost ability to focus at all because of loss of accommodation. Morning vision is blurry in both eyes, but worse in right which takes several hours to begin to clear.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1404769
I went to a lasik ctr advertizing 'throw away your glasses forever. " i was told that nobody gets complications and don't worry, you're going to love it. I originally had monovision which made me very disoriented, and eventually i had acute vertigo. I had the monovision reversed hoping this would help. Within two days, i was hospitalized with intense vertigo that was even worse. I was nearsighted in one eye and farsighted in the other with induced astigmatism. My vertigo never stopped and i ended up permanently disabled. My prescription has never stopped drifting. Prescriptions have been changed every few months for nearly 5 years. I am wearing glasses because contacts were very uncomfortable with dry eye. They do not work very well or very long causing me horrible headaches and nausea from strain. Besides this my eyes are never comfortable and burn constantly. I have ectasia and may need a corneal transplant eventually. I've been diagnosed with binocularity problems and late onset nystagmus which seems to increase with refractive error. The laser was a bausch and lomb. This was never reported and the doctor never even examined me again, but told me it wasn't lasik related.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1403510
A review of the maude database revealed the following voluntary report from a patient: patient reported experiencing "debilitating starbursts, halos, poor contrast and depth perception, and severely limited low light vision. " patient also reports low contrast sensitivity and severe eye strain and was advised that he/she had a decentered ablation.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1403427
A review of the maude database revealed the following voluntary report from a patient: "i was damaged by lasik in my left eye in 2000, by dr. He finally admitted that i had a decentration and wrinkles in my flap, but that he didn't have the laser to fix the problem. I had to go to a specialist in another country, to try to get my eye fixed, but it was damaged too bad and i had to receive a corneal transplant. Dr told me he would foot the bill or reimburse me for the surgeries that it would take to fix my eye, i believed him and never went to a lawyer. Once it came time to be reimbursed, he said he didn't remember saying that he would reimburse me, and my statute of limitations ran out. I never rec'd a dime from him. I had to foot the bill on this myself. I lost my house from these high surgery bills, and now, have to live with a corneal transplant because of this dr. Not one time over the years has he ever dropped a call or a letter to see how my eye was doing. This guy shouldn't even to be a dr in my opinion. He now has a clinic in another country, and i wonder how many other people he has damaged since me. "
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1403431
A review of the maude database revealed the following voluntary report from a patient: the patient reported experiencing severe dry eye requiring punctal plugs and doxycycline therapy. In 2007, the patient reported being diagnosed with "post-lasik ectasia" and irregular astigmatism.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1400305
Underwent lasik surgery and now have impaired vision as a result of starburst and halos.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1399555
An administrative assistant reports a possible overcorrection of one eye following refractive surgery. Additional information provided by the surgeon indicated this patient previously had bilateral cataract extraction with multi-focal intraocular lens (iol) implanted. The patient was happy with the near vision, but wanted the distance vision improved in the left eye. The surgeon performed a yag, which didn't help. Six months following the iol implant surgery, the patient was still dissatisfied with his distance vision in his left eye and the surgeon performed a prk procedure on this patient's left eye. At approximately 5 weeks post-prk surgery, the surgeon stated the corneal surface looked reasonably intact with very minimal punctate. The patient exhibited ucva of 20/50-compared to pre-prk surgery of 20/30-20/40. Bcva post-prk surgery was 20/20. The manifest refraction post-prk surgery showed the patient to be overcorrected in the left eye. Additional info has been requested. The safety and effectiveness of this laser system has not been established for patients with previous corneal or intraocular surgery. (this would include iol implants. ).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1393845
After lasik surgery, my vision at night has become a problem with halos so big it is affecting my night driving and depth perception. It only improved my actual vision from -6. 25 to -1. 25. After seven months since the surgery, the halos are the same and no improvement of my night vision. I am scared.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1393287
I had lasik performed in 2008. The procedure caused me to wind up with dry eye syndrome. I was told to use restasis, take biotear gel caps and eat a lot of omega 3 foods. I have to put drops/gel in my eyes on an hourly basis due to the pain. I can't use the air conditioning or be outside because of the wind/heat/sun -i live in dry. - i have trouble concentrating at work due to pain. I work on a computer all day and i have an ac return directly above me. I was told my life would change -i thought they meant for the better, not worse-. I spend more money now than i did before i had the surgery. I still wear glasses, the only difference is i am in continual pain and have limitations in my daily routines. If i had been properly informed, i would have said, no, thank you. The pain is not worth being able to see better -and i still don't have 20/20-. I had almost a minus nine --9- diopter in both eyes. Believe me in the severest of pain, there are times when thoughts come to you like i don't want to live like this. I can't do this any more. The only thing that keeps me going is that i know in my heart that god is good and he is going to help me overcome this. It's emotionally frustrating because there isn't anything anyone can really do.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1387958
Had lasik procedure for vision correction. Resulted in severe debilitating dry eye in right eye. Also moderate to severe dry eye in the left. Was informed that dry eye was a temporary condition, and would subside in a few weeks. Resulted in poor to extremely blurred vision in the right eye. Glasses will not help due to varying extremes in vision affected by the dry eye. Had no preexisting condition going into surgery, nor was any exam given for existing moisture conditions. Reported this to place that I had surgery done and was told it may take a year or more for it to subside. Duration of time became longer than first information I received. Was on restasis for about 1 year. This had no positive effect on the condition. Condition is painful, and exceptionally bad during the winter months when dryer outside. Can not tolerate air movement of any kind toward eyes. Results in instant irritation and heightened blurring of right eye. Must put drops in 20 times a day or more.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1387769
I had lasik eye surgery on the above mentioned date. I continue to experience extremely dry eyes. I wake up several times during the night and have to put eye drops in because my eyes are so dry they cause me to have headaches. Also, my night vision is impaired due to sensitivity to bright lights. I have the most trouble reading street signs that have white writing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1386944
The doctor reported experiencing cases of DLK (diffuse lamellar keratitis) in some of his pts following refractive treatments. The number of pts and dates of procedures were not known. No specific information was provided. It was reported that the severity of cases of DLK range from stage 1 to stage 4. During the onsite investigation, the AMO clinical specialist reported that one pt being examined presented with stage 4 dlk and corneal melt following a lasik procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1374432
Lasik has permanently damaged my eyes. I suffer from chronic dry eye. My left eye cannot be corrected by glasses or contacts and the prescription varies dramatically throughout the day. I have punctal plugs, am on restasis, flaxseed oil, celluvisc, night masks, a humidifier, and I cannot wear eye makeup. Now I have a vitreous detachment.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1369509
In 1999, I had lasik eye surgery performed by md. I was very nearsighted. I was told, i was a good candidate for the surgery and I signed a bunch of forms. After the surgery, my vision was good until a few years later when it started getting worse again. It has continued to get worse over time and today I was diagnosed with ectasia, -aka- iatrognic keratoconus. I wear gas permeable lenses, but cannot see 20/20 out of my left eye. Glasses no longer correct my vision sufficiently and I have been informed that I may need corneal transplants.
ttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349470
After lasik eye surgery, I have daily eye pain. Headaches, light sensitivity, dry eyes, ghosting.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349475
Lasik surgery had complications resulting in keratoconjunctivitis sicca and epithelial cell ingrowth, followed by glaucoma as a result of prednazone forte 1%.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1353097
Lasik surgery in 2000 - experienced starburst effect immediately, along with dry eyes. My vision has recently started to rapidly regress in right eye, a small amount in left eye. Symptoms: difficulty driving at night, worsened starburst effect, trouble focusing when reading, distance vision impairment. I had to purchase glasses recently, which i was told to wear at night and for the computer. Within 2 weeks, i started having blurred vision, trouble focusing so, went back to eye doctor who informed me, my vision had worsened in my right eye in the past 2 weeks. She ordered a new lens for my glasses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1358375
I had lasik surgery and it pretty much ruined my quality of life. I now suffer from extremely painful dry eye syndrome. I never even knew what dry eye syndrome meant before my lasik surgery. I thought complications were a very, very small percent and now i am reading that the dry eye complications are huge. I think this surgery is a crime against those of us who think it is a miracle, only to find out that our lives are ruined with pain afterwards.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1359009
I am trying to get in touch with, whom i spoke with several months ago about this. I had lasik surgery on both eyes in 2007. Prior to going in for the surgery, i asked the lasik doctors there if i qualify. I didn't think i'd be eligible because my left pupil was overenlarged as a result of a head injury in 1985. That pupil never went back to its normal size. The lasik doctor told me "no problem" when i specifically asked her about the pupil size and whether it would make me ineligible for the surgery. She didn't blink an eye before responding, telling me it's not a problem at all. I was shocked. I thought, "great?" i had the surgery. The surgery resulted in a decentered ablation in my left eye. I've since learned that people with enlarged pupils shouldn't have the surgery. Is this true? what does the fda say about the screening process for potential lasik candidates? thanks in advance.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1364701
Manufacturer Narrative
The laser system was examined and tested at the customer location by an amo service technician. No issues were detected that related to the incident however, it was noted that the y cal platform was misaligned.
Event Description
The surgeon reported a decentered ablation with a patient treated for laser vision correction in the left (os) eye. At post-op exam, patient exhibits loss of best corrected visual acuity due to a nasally decentered ablation. Patient may be retreated to correct vision loss.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1367931
Lasik eye surgery ruined my eyes. Lasik surgeons only look at eyes as a cash crop for them to harvest and make money. They didn't explain or tell me about any of the life altering problems lasik causes. They know that if they did, no one would risk the only pair of eyes they will ever have. The list of problems lasik has caused me. Severe glare severe starbursts double vision - ghosting - bad vision in low light and darkness halos lights that are layered from the light source dry eye severe light sensitivity constant fluctuating vision depression, anxiety and thoughts of suicide.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1335464
The Intralase pt interface was used in conjunction with the Intralase FS laser to create corneal flap(s) for lasik surgery (exact date(s) not provided). The surgeon experienced suction loss during the procedure, which lead to incomplete flap(s). The surgeon reapplied, repeated the sidecut causing epithelial slivers. Postoperatively a small section of the epithelium was removed and a bandage contact lens was placed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349758
The information provided in the copy of the legal complaint alleges that the patient had undergone lasik surgery after the "flap" came off. The doctor proceeded with the laser ablation and did not abort the surgery. The legal complaint states that according to a licensed medical professional the patients cornea measured 300 microns, the patient will need a corneal transplant in her left eye and that she has significant decrease in best corrected vision at 20/50.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349757
The information provided in the copy of the legal complaint alleges that the patient had undergone lasik surgery, where immediately following, she allegedly starting having problems (type of problems were not disclosed). Approximately one year later (2008) patient had an enhancement procedure done on both eyes. She was treated post operatively with steroids (reason for treatment was not disclosed). The legal complaint states that according to a licensed medical professional, the patient's corneas measured 394 microns - right eye and 351 microns - left eye, the patient has a lifetime risk of ectasia and may require two corneal transplants. Her visual acuity measures 20/25 - right eye and 20/60 - left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349756
The information provided in the copy of the legal complaint alleges that the patient had undergone lasik surgery, where immediately following she allegedly starting having problems (type problems were not disclosed). The legal complaint states that according to a licensed medical professional the "patient's corneas measured 382 microns - right eye and 407 microns - left eye, the patient has a lifetime risk of ectasia and my require two corneal transplants. She has a mild decrease in best corrected vision".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1349755
The information provided in the copy of the legal complaint alleges that the patient had undergone lasik surgery in 2008 (actual date unknown), and one day post operatively required a "re-float" of both flaps, where immediately following she allegedly starting having problems (type of problems were not disclosed). The legal complaint states that according to a licensed medical professional, the patient "has severe dry eyes, her vision is significantly impaired. She has dramatic corneal folds in her left eye. Her best corrected vision is 20/70 - right eye and 20/60-left eye. She will likely have permanent vision loss in both eyes.".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1326377
I had lasik surgery and to this day it was the worst decision of my life. The complications from this have affected my lifestyle. I avoid going out at night, due to my visual disabilities from lasik. I am very depressed and constantly suffer from all the complications. I have dry eyes, halos, daytime and nightime starbursts and glaring. My problems started after the day of the surgery when i noticed lots of halos around the lamp post at night and starbursting from car headlights. This really freaked me out, but i was assured by the lasik dr that this will go away and was part of the healing. However, to this day i suffer from it. I am diagnosed with dry eyes and use eye drops every hour. I would like everyone to please do your research and stay away from this procedure. Lasik, in general, is a flawed technique and should never be approved by the fda. I would pay my life savings to get back my crisp eyesight with glasses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1326320
After lasik surgery, I developed what is diagnosed as punctate keratitis, a condition in which the surface of the eyes are not healing. After two months, I have blurring of vision, starbursts, halos, severe dry eye and can't drive. The drs are trying to treat me with contacts and eye drops, but every time the contacts are removed, the surface of the eye erodes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1335379
Lasik surgery ruined my vision. Even though, I reported a severe case of dry eyes to both my eye doctor and the lasik surgeons, during the screening process, the doctors still told me, I was an ideal candidate for the surgery. Since the surgery, by 9:00 pm at night, I can barely keep my eyes open due to the dryness, regardless of how many eyedrops I put in my eyes all day long. Also, I now has double-vision in each eye. Yes, that's right, I see four of everything. Having this surgery done was the biggest mistake of my life and I got to pay for this! The doctors make you sign every waiver possible so that you can't sue them for ruining your eyesight.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1344443
Lasik surgery has resulted in glare and halos in my vision. Objects in a landscape sometimes appear flat, like a paper cut out in a diorama. I have dry eyes, this was never a problem prior to lasik. My vision becomes blurry when my eyes are dry. I get headaches from some lighting conditions, grocery/department store lighting is problematic.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1294955
Patient has allegedly claimed on a public broadcast news report that she was injured during a lasik surgery procedure, which resulted in her requiring sutures on her right cornea and now has a cataract forming. Based on the information presented in the news broadcast, nidek inc is unable to determine the root cause of this injury. Nidek has trained this facility on the proper use of both the ec-5000 and the mk-2000. Nidek has even re-trained this facility on the proper use of the nidek devices. Nidek has provided this facility with on-going guidance on maintaining their devices. No further information of the patient injury is available and has not been presented to nidek. There is no confirmation of this claim and no confirmation of which devices caused this injury. If further information is received, nidek will submit a follow up report. Additional model #: ec-5000.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1310529
I received lasik surgery with a manual microkeratome that was approved by the fda and a nidek laser that was approved by the fda under a pma. In 2000, I suffered a microkeratome failure and the user's colleague admitted to me subsequently in late 2006 that the user of the microkeratome routinely reused the microkeratome blades contrary to the fda's labeling - they are labeled as single use devices, suds. Recently, another patient contacted me who was injured by the same doctor in a similar fashion. I suffered not only a microkeratome failure, but further adverse events including, but not limited to, permanent and severe flap melt, dlk, keratitis, mebomian and lacrimal gland dysfunction, dry eye, loss of day and night vision, loss of vision quality, etc. Emory University has evidence of up to 4 times of an increase in actual suicides from patients who were "satisfied" with their lasik. I know of many patients who killed themselves because their lasik injuries were so severe. Dates of use: ongoing. Diagnosis: lasik. Lasik vision institute no reprocessing 21% or more of users reuse on mult patients.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1293889
I had prk surgery on my eye to correct vision. I now suffer from severe dry eye problems. I was not properly screened or warned before this elective surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1304447
I received lasik eye surgery. Within one to two years, i noticed halos while driving at night and was given night driving glasses. Every year at my annual eye exam, i would complain that my eye sight was deteriorating. In 2007, i was diagnosed with "kerakatonis" in my right eye and chronic dry eye both caused by the lasik eye surgery. I now have to wear expensive synergy contacts and go into my optometrist's office once a month due to inflammation, tear duct plugs falling out, and other problems associated with both conditions. I have to go days without wearing my right contact while my eye heals; however, i can't drive and see well. Diagnosis or reason for use: corrective eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1308829
A surgeon reported one patient with an unexpected outcome following refractive surgery. Patient records were received and reviewed and the patient was noted for a 1-line decrease in bcva in the left eye. During the postoperative period, the patient reported difficulty driving at night, glare and starbursts. The surgeon states he is unsure if the decrease in bcva is temporary or permanent, however, he did say he feels there was no malfunction of the laser and that the laser did not cause the visual symptoms of the patient. Additional information has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1310516
I had laser eye surgery to correct nearsightedness and astigmatism. The dr attempted to give me some vision for the mid-range distance in my right eye because i teach children computer technology and i needed to see their screens. He said he did this by not exactly correcting the eye to 20/20. The left eye was supposedly corrected to be normal 20/20. As it turned out, the right eye is pretty good at 20/30. The left eye is bad. It was bad to the point that i had it done by the same doctor one year after the first surgery. It is now worse than the first time. I have worse triple vision, fuzziness and bad halo effect. I also have very dry eyes especially in the morning when i wake up and can barely open my eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1307448
Pe states after a second laser surgery, she experienced floaters in both eyes. Pe states that the doctor told her that the surgery did not cause the floaters. Reports that she went to her eye care doctor and was told that she had severe dry eyes, epithelial ingrowth, in her right eye and sahara sands in her left eye. States that the doctor who did the laser surgery did not find these problems and will not return her phone calls.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1312323
Event Description:
A surgeon reports a patient with an undercorrection in the left eye following lasik surgery. Patient records were received and showed the patient experienced a 1-line decrease in bcva. Approximately 2. 5 months post-op, a corneal flap-lift was performed with epithelial scrape and refloat to address epithelial ingrowth that was present over the central portion of the eye. The surgeon stated the patient was not harmed/injured and the 1-line decrease in bcva is temporary.
Manufacturer Narrative:
Determination of root cause: assessment: a surgery database performance verification was conducted on this system and the analysis determined the laser performance factors analyzed were operating within specification during the time of this patient's surgery. Non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection were reviewed. This patient presented with a non-contributory medical and ocular history and received an uneventful myopia with astigmatism lasik procedure. During the 6 weeks post-operative period, the patient demonstrated variable ucvas, and similar manifest refractions (mr) and bcvas. The patient was diagnosed with postoperative dry eyes, "irregular epithelium" and "small islands of epithelial ingrowth". Approximately 2. 5 months post-op, the corneal flap was "1/2 lifted" and "epith scrape and refloat" was performed. The slit lamp examination (sle) demonstrated central "flap edema - and central staining. During the 2 week post-refloat period, the patient demonstrated changes in ucva with the final one reported as 20/25 and the sle noted "old, no active oz". No mr or bcva were recorded. The patient also experienced a 1-line decrease in bcva, 20/15 pre-op to 20/20 post-op. Further communication with the surgeon indicated he feels a 1 line decrease of bcva is only temporary and the technician probably did not push the patient to try the 20/15 line (differences in testing techniques). He also indicated that the patient was not harmed or injured by the reported event. During the post-operative period, the patient demonstrated variations in the ucva and bcva indicating the possibility that the postoperative refractive state may not have stabilized, therefore, providing an inaccurate measurement of the residual refractive error and bcva. (regression and its mechanism after lasik in moderate and high myopia, chayet et al, ophthalmology, vol 105:7, july 1998 p. 1194-1199) the usual period for healing and vision/refractive stabilization after refractive surgery is one to 3 months. (aao. Org, refractive laser sx: an in depth look at lasik, a science writers guide, may 2008). The patient was noted for postoperative dry eye. Dry eye may cause temporary and unpredictable changes in the cornea that may interfere with the ability to properly measure the refractive error and or visual acuity, thereby contributing to a potential decrease of bcva (refractive surgery nightmares, fahmy, hardten, chapter 35) and to the reported undercorrection. The 1-line decrease of bcva may also have been associated to the postoperative complication of "irregular epithelium", the "small epithelial ingrowth" and to the dry eye. Although not always serious, epithelia ingrowth may cause epithelial irregularity, threatening to reduce vision. Epithelial ingrowth is a condition where corneal epithelial cells, invade and grow underneath the corneal flap created in lasik, possibly due to poor blade quality, improper positioning of the flap or a gap between the stromal bed and the flap. If signs of proliferation exist, re-lifting of the flap and irrigation and removal of the cells is indicated to prevent major corneal complications. (rates of epithelial ingrowth after lasik for different excimer laser systems, roo et al, j of ref surg, vol 21:3, p 276-280, may/june 2005) (epithelial ingrowth after laser in situ keratomileusis, wang and maloney, am j of oph vol 129:6 june 2000 p. 746-751). Conclusion: based on the results of the investigation of product and non-product factors, the device was not found to be a contributor to the patient's outcome. However, the non-product related factors mentioned above may have been contributors.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1280733
I had lasik surgery - i am now dealing with significant dry eye which has compromised my ability to complete daily tasks, including the ability to work productively. The dry eye is, quite simply a disability for me. I really struggle in office environments with florescent lighting. While lasikplus - the company who did the surgery is still providing care to me, the consent process was, in my opinion, glossed over - involves the reading of a pamphlet only and a required signature-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1282209
Halos during night & day, dryness / irritation of eyes always.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1284908
I had lasik surgery to my left eye and prk to the right eye in 2007 at the vision center...[snip] My eyes were in constant pain following the surgery and lasted for months. The nerve endings were supposed to heal within 2-3 weeks, but in some cases they never return to their normal or previous state. This is something that i was not told before having the surgery. If they would have told me this i would have passed on the surgery. The bottom line is that i suffered daily with pain, dryness, and burning for almost 9 months. I experienced periods of deep anxiety, depression and the inability to sleep that began about 30 days after the initial surgery. The resulting surgery has left me with extreme night vision problems including halos, star-bright and double vision. I'm afraid to drive at night. Following the surgery, i suffered with high anxiety and depression for over 8 months, which resulted in having to take many strong medications for anxiety and depression, including 3 days in a mental facility. I still take the anti-depressant medication and suffer daily with vision problems that affect my ability to read. My job requires that i work on the computer all day. The resultant surgery almost cost me my job due to lost work days and the inability to travel. For the first 6 months following the surgery, i experienced extreme difficulty sleeping and had to take strong addictive medications, such as lorazepam - anxiety- and ambien cr sleep deprivation. It has been 21 months since the surgery and my vision is still poor in the both eyes. Additionally, more in the right eye. I meet with dr wright at the vision center in 2008. After several tests, dr(first) indicated the right eye prk surgery could not be corrected. Additional surgery to the right eye may not improve the astigmatism or the halos and star-bright conditions. Dr(first) configured a pair of eye glasses after his examination hoping that it would improve vision in the right eye, but proved useless. The story does not have a pretty ending. Prior to the surgery, my eyes were correctable with eye glasses. After surgery both of eyes maintain the astigmatism and include additional defects such as halos, star-bright, and double vision. Not to mention the visual daily strain on my eyes because of the astigmatism. Unfortunately, i was one of the few that experienced sever problems as a result of the eye surgery. The fact that no support structure was in place for patients who experienced that trauma as i did made the situation even worse. I tried to get help from lasik plus, but all they could say to me was , we are sorry. My family went through a very painful period after my surgery. I was fortunate to have a wife who prayed and comforted me through this period but after 6-7 moths of being up all night and having to stay home with me during some of the rough days, it took its toll on her as well. If it were not for my strong relationship with jesus christ and many christian brothers and sisters praying for me daily, would have most likely taken my life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1287043
I had lasix surgery about 5-6 years ago. My eyesight was so bad i couldn't see the e on the eyechart. Within the past year-year and a half, i have needed glasses for distance. In fact i will be required to wear them for driving. I called the doctor's office that did the surgery and asked about having it fixed, and was told that nothing could be done to help me. Is the fda keeping track of problems associated with lasix? i would do it again but i'm disappointed that my eyesight has become nearsighted again.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1252365
Since having intralasik eye surgery, i have developed posterior vitreous detachment or severe floaters. I have also suffered from dry eye as well as eye strain. The suction cup used in the lasik procedure sucks out vitreous opacities from the back of the eye leading to the appearance of floaters. Lasik doctors do not inform their clients on the possible dangers that the suction cup may have on the structure of the eye or creation of floaters. Lasik doctors also misinform their clients by telling them that nerve regeneration will occur after nerve severing is initiated. The truth of course is that there are no recorded scientific evidence that nerve regeneration fully occurs. In fact, 5 year studies from school of ophthalmology find that nerve regeneration reaches only 80 percent of preoperative levels. Five years, imagine eye doctors telling their patients that it may take as long as five years for their cornea nerves to regenerate 80 percent, that is, if they do at all, there is of course no guarantee. It is no wonder that dry eyes is the most prevalent side effect after lasik, doctors simply distort the facts to advance their cause. The fda has completely dropped the ball when it comes to holding the lasik industry accountable for medical malpractice. There is ample data from credible doctors and universities that substantiate my claim that lasik is harmful to the eye, and that doctors knowingly mislead the patient in the hope to secure his or her business. The facts are simple, lasik creates dry eye, floaters, compromises the integrity of the eye, and in many cases creates psychological cases of depression, hopelessness and disillusionment toward humanity and its supposed hippocratic moral keepers. The fda and its lobbyists are just as complacent in this farce as are its executioners. In fact, one could say the fda, as supposed guardians of the people, are even more at fault for allowing such a "abject" procedure to manifest itself. Evil permitted is sometimes worse then evil committed. Its time for the fda to redeem itself and put an end to lasik surgery once and for all, or at the very least force doctors to be as a honest and forthcoming about the potential side effects of lasik as i am now. Wishful thinking.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1250367
Doctor did lasik surgery on both my eyes at once. Seven days later, opened my left eye. Again, i had complained of pain and could not see clearly again, within a week, opened it as third time. I finally woke up only seeing brown and white blurs without structure. I was taken to his office by my daughter and he didn't know what else to do. He had never seen this before. He sent me to first specialist who called him back. It was another dr. Went right from first dr's office. Second dr helped, but within days i was totally blind. For 5 or 6 mos while healing, i could not see at all and was bed-ridden, only getting up to feel along the wall to my bathroom. Second dr says i will need a cornea transplant in future. I was taken to second dr's by friends and relatives until i could see enough to drive some time early 2000. I had to go back to my waitress job in 1999- my son drove me. With only limited clear vision, the other waitresses made sure i had right orders in computers and picked up right food to deliver. I would have lost my house without their help. Second dr saved my eyesight! i still have permanent damage, i see light halos at night, cannot drive in rain as cannot see where road ends. Dept of vision is still a little bad, and scar damage is severe-stigmatism. I have to have bi-focals. My eye doctor(third), says my eye cornea is the thinnest he has ever seen. Us marshalls convascated his equipment sometime after my surgery in 2000 not sure of date. First dr's homemade device design-experiemental.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1275406
I had lasik performed in 1999 and an enhancement in 2000. It was performed by dr at hospital. I have had a disabling glare and vision problems ever since. I know that i filled out a disclaimer for the surgery. What upsets me is the fact that pupil size and dry eye were never discussed, and the possibility that vision indoors and in dimly lit situations would be effected. This information was not in the disclaimer. I now use alphagan p off label, which is also a questionable practice. I did not know that the fda was the proper forum to file a complaint until recently.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1029649
I was told that the fda was holding a hearing or discussion about post lasik problems. The contact person was karen warburton, but i didn't know how to get this to her. I had lasik surgery in 2002, and it has left me disabled. I am in constant discomfort and pain due to severe dry eye. I am not eligible to receive medicare for another two years which means i have no health insurance. I have lost two homes and can no longer work at my regular job due to this problem. I have halos, starbursts, sensitivity to light, can't tolerate wind or air from fans, can't go to shopping malls or stores without extreme discomfort which has lead to depression and anxiety. Please hear my voice!!! this surgery is a lot more dangerous than most people will admit. I feel like my life has been ruined. And the thought of living the rest of my life with this pain is horrible.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1018959
I had lasik surgery with a bad outcome that has affected my entire life. I know i signed a consent form that stated the possible poor outcomes. I though a poor outcome would mean that i would still need to wear glasses. I now have high order aberrations and a mixed astigmatism in both eyes. I had problems right from the onset. At each exam, i would tell him that i had blurry vision and that it looked like the letters were all jumbled and unclear. Later, i would identify it as multiple vision. Night time is a nightmare. He would always say it will be alright and that i would need a enhancement. Which i had. There was no improvement. I had blepharitis, and many other visits to him. After my initial enhancement in both eyes, i continued to have problems. He then told me i needed to have endo or epithelial cells scraped from my left eye. I was worse after that. Finally, i told him i wanted a second opinion. He referred me to a center and surgeon that had trained. This physician's initial response was that my problems could not be fixed with repeated lasik procedures and that the first physician should pay to have them fixed. This is the first time that i had a name for my problems. The second physician has tried two procedures to fix my problems. I think my night vision may be worse. After my second procedure with the second surgeon, their laser was recalled. The only way i found out was through yet another surgeon. I don't know what to do. My concern is not only for myself, but for others. How are their complications reported? this is a cash industry for the most part. If my complications were reported by him would i have been informed? i wish there was a website that dealt with each physician's complication rates. When you make your pre procedure appointment, this website should be given to you and you should receive a form for reporting your own complications. I am very doubtful these are accurately reported. Since my procedure, i am aware of 7 other people that had very bad outcomes with him. I think what bothers me the most is that he was not straight forward with the severity of my problems. When i went to the second opinion surgeon, he used equipment to test and diagnose my problems that the first physician did not use. This equipment is what gave me my diagnosis. Lasik laser in surgery center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1015950
Allegretto wavefront laser for lasik. After lasik i developed terrible floaters that interfere with many activities. It is a terrible experience. Date of use: 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1013926
Lasik surgery for nearsightedness - laser "skipped" when making initial cut. Laser scraped my eye, preventing completion of the surgery in one eye - other eye completed successfully during same appointment. - healing of the scrape took about 4 months. Also led to significant pain, lost time at work, and periodic "erosions" in my eye. Vision in that eye is now corrected with contact lens. Erosions still periodic, but treated with steroid and lubricant drops as needed. Erosions a year later still cause a good deal of pain and lost time at work. When not wearing the contact lens, contrast in that eye is greatly impacted to the point that i cannot complete tasks up-close without the contact, which was not the case prior to surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1007129
Serious, severe dry eye syndrome developed within 3 days of surgery and i still have it 18 months later.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1007161
Pts treated on the visx star4 laser at facility. The results of said treatments were a range of pts who were over corrected or partially treated. As a result, the pts corneas were made irregular. Some pts requiring further treatments; some pts whose cornea irregularity is so severe, no add'l treatment will correct the vision. The problem was reported to both visx and the parent company of the facility, in september. Many calls were made to visix and several service calls were made to the facility. Add'l statements available upon request.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1002386
An attorney reported his client alleged "severe permanent injuries, pain, suffering, disability, impairment and loss of enjoyment of life" following bilateral lasik surgery. In addition, the plaintiff alleged the "laser system was defective and in an unreasonably dangerous condition". Add'l info provided indicates both eyes were affected. This report is for the left eye, the right eye was reported under mfr report #1061857-2007-00467. The pt was treated with a custom myopia with astigmatism treatment. The target for both eyes was plano. At 1 month post-op, this pt was overcorrected in the left eye by +3. 00 diopter and experienced a 1 line decrease in bcva. Ucva improved from 20/cf to 20/100+2.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047302
A system operator reported the laser stopped firing during calibration prior to the next procedure. The pt's flap had been cut and they were unable to proceed with the surgery. The pt was re-scheduled for the procedure and the system operator indicated the pt was "doing well" following the surgery. The surgeon stated the patient was not harmed or injured by this event. Additional information provided indicated the patient's bcva in the right eye decreased one line from 20/15 to 20/20-1 at one month post-op.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047104
I had monovision surgery done 1 year ago. It has been a nightmare. Starting with extreme glare problems inside and outdoors to hazy vision. I was told after my surgery that my eyes are dry and have used countless different eye drops. No one explained prior that i would not be a good candidate for the surgery because of my dry eyes. I never used eye drops prior to surgery. They charged me to put in plugs which did not help either. I am currently taking restasis which makes my vision blurry too. I paid for this more for what they called "high definition" eyes-which i know was a rip off now.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047108
I had lasik eye surgery, which resulted in a litany of problems: dry eyes, ghosting, starbursts and halos at night; an inability to see in low-light situations, and a regression of my vision in my left eye that necessitates the wearing of glasses at all times. I am unable to drive at night very well. I also have recurring infections. I suffered from depression after my eyesight was negatively affected. I was a high myope with large pupils and probably had a pre-existing dry-eye condition that the doctor did not screen me for. I was a terrible candidate for this surgery, but it was done anyway, to my everlasting despair.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047292
A system operator reported the laser stopped firing 67% into a procedure due to low energy. The site was advised to perform a gas change and recalibrate the system which was unsuccessful. The procedure could not be completed at that time. Pt records were provided and indicate at approximately 6 weeks post-op, the pt's right eye was undercorreted by -1. 25 diopter and there was a 1 line decrease in bcva. No further info was provided.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047149
Pt states that after having lasix surgery, she started to have "black spots and smoke trails" in her vision. Her doctor told her that her vision was over corrected.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1048166
Lasik eye surgery. Every day since surgery, i have had eye pain, burning, stabbing pain, gritty feeling and horrible headaches. I am unable to drive at night halo's, starburst & blurred vision. Any bright lights cause severe pain and blurred vision. I spend about 2 of the 8 hours of work each day, without being able to see clearly enough to do my job. Outside of work, i am forced to stay in my home with the lights out. I had continued to go back to the facility that performed the surgery and have been given the following suggestions: none have made any difference. Directed to sue every brand of "drops" on the market. Do not run any ceiling fans at home. Tape eyes shut at night. Do not go in the sun. Stop smoking. Restasis - used for 4 months and told to discontinue because they didn't help. Now i'm being told to go back on and that it would take up to 2 years for results. Punctal plugs were put in. Do not go in the wind or let any air blow in my eyes. Take fish oil pills. Take flax see oil pills. Limit my time on the computer. I work for a software company.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1050087
After carefully researching existing lasik procedures and the available providers, i made an appointment for the initial evaluation. I had worn glasses since the age of 10, but was quite capable of getting around without them--my eyes were not that bad! during the exam, i was repeatedly asked if i had a problem with dry eyes to which i replied no. -understand, if one knows nothing but what is present, how could i know that my tear production was abnormal? i had never been able to wear contacts and, in hindsight, this was probably due to low tear production, but, other than this, i had no indication of this condition. It was not at a point that it was uncomfortable or debilitating. - i was approved for the procedure without reservation. During the procedure, the epithelium of my eye came off -both eyes-. A contact was put on to hold the tissue in place during the healing. I was more or less "blind" for the next 5 days. When removed, the epithelium was again loosened and the contact had to be replaced. The healing process was long and extremely uncomfortable. For the next month, i wore sunglasses almost constantly and my eyes are still sensitive to bright light. I have had 3 corneal erosions since then. I must put a thick gel in my eyes at night to keep them from drying out, resulting in another corneal erosion. I have tried drops, medicine -restasis-, supplements--all offer minimal relief. I have placed a humidifier in my house to try and further relieve the discomfort. While i do have 20/20 vision, i would gladly go back to wearing glasses in order to relieve this condition!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1050118
I had lasik from a dr about 6 years ago. It ruined my vision, and gave me permanent eye pain and dryness. I now see severe halos, ghosts, multiple images, streaks, starbursts, and my vision fluctuates terribly. My contrast sensitivity and depth perception are ruined. It affects my work, my hobbies, every aspect of my life is pain and difficulty. I wake up in the middle of the night from the painful dry eye. I never knew depression until lasik. It's hard for me to believe this horrific lasik procedure is fda approved. These problems are permanent and can't be fixed. I've been to many doctors and none of them can do anything. Dr lied to me about the quality of vision, dryness, side effects, risks, and remedies if something went wrong. He told me that night vision problems were due to older technology and they had been fixed. He told me lasik can't cause permanent dryness. He told me this would be better vision for tennis. He reported that i was "off to a great start" to a referring doctor at a time when i was already experiencing these terrible and permanent problems. I was retreated with ladarvision several months later. The ladarvision didn't fix anything.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1050083
I had lasik surgery on both eyes in 2003. My eyes were burnt red for 4 months. I had pressure in the right eye. At first the vision was fine - now i have cataracts that my physician said was caused by the lasik surgery. I went to a different dr and had the cataract removed on my right eye and now i still have to wear glasses because they could not correct the vision with the lens put in for the cataract surgery. I wish i would have never had lasik because now my eyes are ruined, and i have to wear glasses again.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047164
I was treated on a visx laser with a 6mm optical zone. My pupils are 8mm. I was not warned that i was a bad candidate. Now i am visually disabled in dim light. At night, i see massive starbursts, halos, and multiple images. Nothing is crisp and clear in dim light-loss of contrast sensitivity. I can't drive at night or participate in any activity in dim light. I had also become contact lens intolerant before lasik which i now know is a sign of dry eyes. My eyes burn constantly and i have recurrent corneal erosions. To say that lasik has negatively affected my quality of life doesn't even begin to cover it. No one, expect other pts who have personally experienced this, can understand what life is like with visual impairment that is not correctable with glasses and non-stop burning dry eyes. I can't tolerate air conditioning, ceiling fans, wind or open a hot oven door. Now my life is all about my eyes and just getting by. The fda should have restricted lasik devices based on pupil size, and placed stronger warnings in the labeling about dry eyes. The fda commissioner said that the fda exists to serve the people, not to serve industries, but it appears to do just the opposite.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1044918
I had lasik over a yr ago and have had nothing but problems. I have voiced my issues with lasikplus, but they say my vision is great. No, my vision is not great, i saw better with glasses. I have the following issues: constant dry eye, halos and bad night vision, eye fatigue, my right always has a haze to it. I now have blurry vision when looking at things close-up. After looking at info on the internet, i have read that people with large pupils should not have the procedure. Well, i was told that i have large pupils and that i was still a perfect candidate for lasik. If i had to do it all over again, i would most likely not have lasik. It is great not having to wear glasses, but without the procedure i would have better vision, no dry/irritated eye, better close-up and night vision and wouldn't have to spend a fortune on eye drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1044651
After my lasik surgery, i could hardly see out of my left eye. Driving was an issue and working at the computer, which i must do for a living, was difficult at best. A second procedure or adjustment was done on that eye, but vision did not improve. After several months of waiting for it to get better, a new surgery date was scheduled to remove cells growing under the cornea flap. To this day, i do not know what exactly was removed, what caused the cells to grow, or how could i have prevented - if that was possible - this from happening since the info provided to me was hard for me to understand. Since that third procedure my eyesight has improved, but i can not see far away as well as i expected. The doctor has hope that as my eye heals that vision will improve. I hope that's right. All in all it has been a scary and disappointing experience. I did plenty of research before making the decision and knew that a small percentage had night vision problems with glare, but i was not prepared for three surgical procedures, the discomfort associated with these, and the scary possibility of losing vision in one eye. At this point i would not recommend the procedure. Too much is at stake, and many things can go wrong.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1044654
I had mono-vision lasik performed in 2005. My vision has not been clear since the surgery, i now have very dry eyes that require prescription drops twice a day, and re-wetting drops several more times a day, and i am wearing glasses again to correct my vision, so i can drive and function. I regret the decision to have the procedure, and will advise everyone i know considering have it done not to do it!!! lasik plus.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040900
I had lasik surgery on both eyes. My results have not been good. From that day forward they have diagnosed me with severe dry eye in both eyes but worse in my left eye. My eyes burn a lot, i have blurry vision, halos at night, very sensitive to light, painfully dry. They have tried everything to correct the problem, drops-restasis, steroid, wetting, punctal plugs, flax seed oil pills, vitamin e pills, night cream, taping my eyes closed at night, humidifier in home & office. How it affects my life: my vision is not 20/20 because of the dryness. And i do need a correction in one eye but there is no way i will do that again. I have to wear sunglasses at all times outside because of wind and sun, and a lot inside too. I need to constantly put wetting drops in. I have been on restasis for three years and they have told me probably for the rest of my life. I cannot drive at night. My job requires computer work which makes my eyes worse every minute i am on the computer. I cannot sit anywhere where there is wind from a fan or any other device. Because of having the punctal plugs in, my eyes water a lot, i have to always carry a tissue to dab my eye with so that i don't have tears streaming down my face. I wake up in the middle of every night to drown my eyes with more wetting drops. I cannot live without a humidifier. I live in a city which is very dry during the winter and it is torture. There is not a minute of every day during our winter that i am not aware of my severely dry eyes. At times, it feels like my eye lids are scratching my eyes. My eyes are always bloodshot, and the whites of my eyes are turning yellow. This should not be happening. The facility says that the dryness gets under control in the summer and the last thing left for me to do is move to a more humid climate year around. They don't know why this happened or what else to do. They have always been very nice. I never had a problem with dryness before this surgery or any other eye problems. This has affected my life more than anyone would ever know, if i could go back i would not have this surgery done. Beside the health side effects, there is the expense. I have had well over 50 appts and i live 40 minutes away, so besides gas money, there is all the time off work. And the expense of all the prescriptions. Wearing glasses and contacts are 100 times better than what i have been through in the last three and a half years.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040892
I had prk lasik surgery. I now have a very high reading rx 3. 25 and still need mild rx for distance. I have severe dry eyes. I now need to use eye drops 4+x/day and need to have the tear ducts plugged. I also have to use restasis prescription drops 2x daily. I also am taking theratears nutrition omega-3 capsules daily for dry eye problems. I was told i would need reading glasses after this procedure, but the rx is very high. I only needed 2. 50 distance rx prior to surgery and no reading rx. I must tell you that i also work with the md that did my surgery and feel that i was not informed well. I know that i was over-corrected with this procedure. But i had much discomfort with the recovery. It has been over one year and i still have issues. I am distraught emotionally to accept the high dependency on the close vision needs. I no longer can see in the mirror clearly. I need glasses to see the food i am eating from my plate. It has been quite an emotional rollercoaster. I need my reading rx as well as magnifying mirror just to tweeze my eyebrows! this has been extremely upsetting as i know i will probably continue to need stronger reading rx help as i grow older. I did bring this to the attention of the management at my workplace, and they only responded "i guess you are just in the percentage of people that are not satisfied with the process. " how is that for an employee of this practice! i work for opticare.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040904
I had a lasik procedure done in both eyes last year in 2007. Doctor performed the surgery. The procedure i had is called "custom" lasik - intralase -bladeless-. I was told that this is the safest procedure. Since i had the custom lasik, i have been experiencing several complications. Please see list of complications below: severe chronic dry eyes -i am currently on restasis and have 1 plug in each eye-. I tried 4 plugs, but could not have 4 plugs because tears would not stop flowing. So i now have a total of 2 plugs -one in each eye-. Dlk -with recurrency-. Halos, glare and starbursts making it very difficult to drive at night. I still have some remaining miopia and i am using glasses to drive at night. I do not want to have an enhancement done due to severe complications. - contrast sensitivity. I now need reading glasses and glasses for the remaining miopia -0. 5 in the left eye and 1. 0 in the right eye-. I have never had any of the problems mentioned above before the custom lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040882
I underwent lasik surgery in 2005. I had been a contact lens wearer since age 13. My initial pre-operative exam did not include a measurement of my tear production. Since lasik surgery, i have been plagued by chronic dry eye. With sign/symptoms of constant red eyes, discomfort, and occasional visual blurriness due to the dryness. I am on restasis, have had punctal plugs, both in the superior and inferior puncta, use gel drops throughout the day, wear protective glasses at all times, and use a night time ointment every night. I currently have "smart plugs" in the inferior puncta. Unfortunately, my smart plug on the right has caused severe inflammation, infection and granuloma formation, which now requires surgery under general anesthesia to remove the plug and place a lacrimal stent that will be removed after six months. It is believed that i had undiagnosed chronic dry eye and should have never been a safe candidate for lasik surgery. The lasik most likely only exacerbated my original dry eye problem. Had i been adequately screened, i would have never undergone the surgery. It is the worst decision of my life, a decision i would have never made if i had been appropriately screened and given the correct medical advice. I feel comfortable saying this, because i am also a physician and take patient screening, diagnosis, appropriate treatment very seriously. I'm afraid other patients are being given a great disservice with a procedure that is being taken too lightly.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040883
My cornea was torn in several places when the doctor was attempting to create a flap for my lasik procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040886
Had lasik surgery and now experience halos and starbursts around lights at night. This happened even though i was assured that my pupil size and cornea thickness were within the acceptable range to avoid these problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040888
Lasik performed by a dr in 2001. I was a high hyperobe [over +6] and since that time have suffered from fluctuation in vision [severe fluctuations] which occur day to day, hour to hour and from morning to night. I suffer from significant problems with glare, have lost contrast sensitivity, and see starbursts and halos. I cannot drive at night unless i know the area well, cannot read most signs day or night, and am in fact a danger when i drive at night, which i almost never do. This has had a negative impact on the quality of both my vision and my life. Contact dr's office for medical records.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040901
Lasik : severe dryness, double and triple vision, constant pain, excessive purchase of artificial tears, need topography done for possible corneal damage.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039107
Patient reports that in 2006, she had laser surgery on her left eye and 2 months later, her right eye was done. Patient states that she now has decreased vision. She has blurring vision, light sensitivity, gritty feeling and pain. States that she is unable to drive and she sees starbursts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040309
I had lasik eye surgery and i've noticed a very bad reaction in my night vision. I see "halos" and "star bursts" around bright lights and it's very difficult for me to focus and keep my vision crisp or tight. I've noticed this problem getting worse and i only had my surgery less then 2 years ago. I find myself considering getting new glasses just for use at night. I had my surgery at the lasik vision institute.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040319
Lasik surgery, in 2008, i had lasik surgery performed at eye care center. Before the surgery was performed, i was shown a video on lasik that listed some of the potential side effects and read and signed forms also notifying of potential side effects. In addition, i specifically asked the surgeon -who is a cornea specialist- questions regarding loss of vision over time following the surgery and potentially needing bifocals if this was to occur. The surgeon assured me that although there is no long term guarantee on my vision, he was confident that with my age and healthy eyes i was a perfect candidate for lasik and should not need to worry about this or other issues/side effects. He also told me that he provided a one year guarantee to all of his patients and should my vision not be 20/20 i would receive enhancements to get it there. My vision is 20/20 now, but since my surgery i have been dealing with severe dry eye issues, i had no eye issues before the surgery except low-vision. I now will need permanent eye plugs and have two eye drops prescribed to help combat the problem, which includes restasis and topical steroid drops. My current ophthalmologist said that he cannot install the eye plugs for at least a month as my eyes are too dry and doing so may increase the chance of infection. I also have to use eye drops at least every hour throughout the day and anytime i wake up at night. The eye care center is no longer in service, the one year guarantee cannot be met as promised and there is no follow-up care. The follow-up appointments i had at eye care center before they closed, i complained of the severe dry eye symptoms each time and was told to just use drops and it should get better, i asked about getting dry eye tests done and they said it was not necessary, but would instill temporary eye plugs in my bottom holes to see if it helps.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040330
I had lasik surgery on both eyes. The next morning, i had double vision. Starburst when looking at lights or oncoming cars. By 02/02/05, i could no longer drive at night. A second surgery was done on my right eye with no improvement. A second surgery was planned on my left eye. At that time, i went to get a second opinion. The doctor told me do not let the doctor touch my eyes again. Whatever was steep enough and could cause more damage. He also said "i cant believe he wants to do more surgery on my eyes because i had cataracts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040349
Patient with no previous or family history of glaucoma had lasik surgery in 2005. Shortly thereafter, the right eye developed increased intraocular pressure, which was at the time attributed to steroid drops, which required emergent surgery for glaucoma with a trabeculectomy. Approximately 2 years later, the left eye (in the absence of any concomitant medications) was found to have increased intraocular pressure, eventually diagnosed as juvenile glaucoma requiring chronic treatment with eye drops. Lasik has not been known to be associated with glaucoma, however, it was felt that this should be reported. Dose or amount: single treatment. Dates of use: 2005. Diagnosis or reason for use: corrective vision surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040350
I had lasik in 2007. I now have chronic dry eye. While i did have dry eye symptoms prior to the surgery along with dry mucous membranes and joint pain, i was told that i was still a candidate for the surgery. In the past, i have had a work up, including negative tests for ra, lupus, connective tissue disorders and sjogrens. Since the surgery, i have dry eye, eye fatigue, redness, light sensitivity and my vision fluctuates. I am on restasis, fresh kote, systane, thera tears, flax seed oil supplements and i'm taping my eyes shut at night. Computer work, reading and driving are difficult.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040354
I received lasik in 2002 on both eyes. Things went well for three years. My vision acuity was 20/20. In 2005, i started to notice blurring in the vision of my right eye. The doctor i was receiving treatment from said that it was nothing and that my vision was the same. A year later, 2006, i started to notice more significant changes in my right eye. My visual acuity was now 20/40 od and 20/30 os. I also complained of blurriness. I decided to receive a retreatment on my right eye, but not on my left. In four months later, i received the retreatment. After the surgery, my visual acuity was 20/25 od. I was complaining of blurring and double and triple vision, especially at night. The doctor's office recommended another retreatment. In approx two months later, i received a second retreatment on my right eye. My visual acuity remained 20/25 in my right eye, but there was still a lot of ghosting and double/triple vision. I decided to leave the doctor's office at this time. In 2007, i went to a local ophthalmologist seeking glasses and contacts to help with my vision. The doctor diagnosed me with keratoectasia. Most likely caused by the lasik. My visual acuity was 20/40 od and 20/25 os. I was fitted with a synergese contact lens. They worked well for a while, but my vision began to fade again, due to the bulging of my corneas. I knew that this would happen due to the nature of the disease. Due to worsening condition, i sought out further care for my eyes. After months of researching, i decided to receive further care. In 2008, my visual acuity was 20/100 od and 20/40 os. The ectasia was progressing fast. In the same month, i received intacs in both eyes. I also received ck - conductive kerotoplasty - in my right eye and c3r - corneal collagen crosslinking with riboflavin - in both eyes. Since then my visual acuity has gotten better. Va od is 20/60 and os is 20/20. My vision is still fluctuating to this date. Thank god for these procedures. I am functioning right now unaided and doing much better. I'm more then certain, based on what i know and has been evaluated by the many doctors that i have seen, that my flap thickness was cut too thick and this is what caused the ectasia. This has effected me greatly. I'm a firefighter and need my vision to work. The nasty part of the disease is that it caused me the inability to function with soft contacts and glasses. This is a problem for someone who is required to respond to an emergency in the middle of the night. I couldn't just place a contact in my eye within seconds of waking up. Hopefully, the treatments and procedures i received the same month, will allow me to function for years to come. So far things have gone well, and i hope that they continue to. I'm very happy to see that the fda is getting involved with the requirements for lasik. Lasik is destroying lives right now. Doctors' careless attitudes are also destroying lives with the use of lasik. I would guess that in several years lasik will be a thing of the past and nobody will be performing it any longer.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1040321
I got lasik surgery from a dr. I have had complications ever since. The main problem is severe dry eye which causes constant pain. I never go to speak to the doctor before or after the surgery. They really rushed me through, and i am sure they include me as a successful surgery because my vision is better. No one ever asked me if i was satisfied. They even told me another surgery might make the dry eye go away. I have found no information backing up that statement. It makes me sick at my stomach to even think about the place where i had this done. They are obviously only interested in making money and don't care about the patients. Since the surgery, i have spent thousand's of dollars on doctors, eye drops, special glasses, and other items. I have even had my tear ducts plugged to keep the moisture from draining. Some things help, but i have come to realize that i must live with this pain forever. People don't think dry eye is a big deal, but the chronic pain can be devastating. I drink water constantly and take a nap every day just to try and make the pain go away. Please let people know about people like me. There are more than anyone knows. Just take a look how many eye drops are on the market. It is absurd.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1061866
I have had lasik surgery twice now and i am going blind. I was never told that there "might" be a possibility that this could happen. I have been living a lasik nightmare for the past 4 years and i have been to countless doctors and they have no idea what i have and i should just live with it and be thankful that i am not blind yet. I have triple vision and i can't see at night and i cannot go back to work because i can't see. I cannot drive anymore. I have to carry a lens with me that makes everything bigger. I can't see after dark and i can't see when it is bright out. I know that there is someone out there that has a solution for what i have -although i don't have a diagnosis yet- lasik needs to be researched further more before the procedures are done. Or there should be a better pre-op testing procedure. My life has been ruined due to lasik and i cannot receive any compensation. While lasik might be right for some people, it isn't right for others. I have been damaged from it and i hope that other people will think before they have this done. Trust me, it is not worth it. I would give anything to wear glasses again. I have two small children to raise and my biggest fear is that one day, i will wake up and i will not be able to see them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1061336
I had disastrous lasik performed in 2007. On the day of surgery, i had second thoughts - the office staff was very pushy, instructing me to take three valiums and then decide to have the surgery. How is a person to make a logical decision about an irreversible medical procedure under the influence of powerful drugs? i went ahead with the surgery, and as a result, i face many life-altering complications that i now know are common after lasik. I feel that dr does not thoroughly pre-screen his patients for dry eye. I clearly told dr and his office staff that i was unable to wear contact lenses due to dry eye, which is a red flag for the development for serious post-lasik dry eye - yet they told me that i was a good candidate for the surgery! after surgery, i immediately experienced overwhelming pain that continues to this day. Lasik surgery involves cutting into the cornea, severing crucial corneal nerves, resulting in chronic nerve and dry eye pain in many patients. I am currently on 3 medications to handle the pain and anxiety i feel as a result of my lasik disaster with dr dean dornic. Dr and his staff were very impatient with me after the surgery, insisting that 'there is no medical reason' for my pain, although there is much peer-reviewed medical literature to support the existence and mechanism of post-lasik eye pain! i have missed countless days of work, my family does not understand what i am going through. I am in constant pain and the meds to control the pain make me groggy. I want others to know about the comfort and quality of life that i have lost, so that they can make a more informed decision about lasik eye surgery. Lasik doctors should be controlled by the fda.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1061336
I had disastrous lasik performed in 2007. On the day of surgery, i had second thoughts - the office staff was very pushy, instructing me to take three valiums and then decide to have the surgery. How is a person to make a logical decision about an irreversible medical procedure under the influence of powerful drugs? i went ahead with the surgery, and as a result, i face many life-altering complications that i now know are common after lasik. I feel that dr does not thoroughly pre-screen his patients for dry eye. I clearly told dr and his office staff that i was unable to wear contact lenses due to dry eye, which is a red flag for the development for serious post-lasik dry eye - yet they told me that i was a good candidate for the surgery! after surgery, i immediately experienced overwhelming pain that continues to this day. Lasik surgery involves cutting into the cornea, severing crucial corneal nerves, resulting in chronic nerve and dry eye pain in many patients. I am currently on 3 medications to handle the pain and anxiety i feel as a result of my lasik disaster with dr dean dornic. Dr and his staff were very impatient with me after the surgery, insisting that 'there is no medical reason' for my pain, although there is much peer-reviewed medical literature to support the existence and mechanism of post-lasik eye pain! i have missed countless days of work, my family does not understand what i am going through. I am in constant pain and the meds to control the pain make me groggy. I want others to know about the comfort and quality of life that i have lost, so that they can make a more informed decision about lasik eye surgery. Lasik doctors should be controlled by the fda.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1061846
Lasik surgery to correct vision. The surgery was done. As a result of my surgery, i have severe, chronic dry eyes. I insert lacriserts in both eyes daily; they blur my vision but do offer some relief. I also use restasis eye drops, theratears liquid gel, and i take 2000 mg of flax oil per day. I have lacrimal plugs in both eyes in both punctum. Sometimes the pain is so unbearable that i am forced to wear swimming goggles to protect my eyes from the air. I've seen three ophthalmologists, and they all agreed there is no occular treatment for my condition, and that the condition is permanent. In other words, my eyes are not going to get any better.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1061874
In 2003, i underwent a bilateral lasik procedure on my eyes at lasik plus. A dr performed the procedure. In the mos and yrs that followed i developed worsening vision, starbursts and halos, until the point that images began to double and multiply. I did not know it at the time but have since been evaluated by other drs and told that i now have a condition called ectasia and it is directly due to having underwent lasik. In 2005, my left eye had gotten so bad that i had to have a cornea transplant. My right eye also has ectasia and will require a transplant as well. For me the "problem" and "user error" is the fact that i feel lasik plus does not allow for adequate screening, lasik plus advertises as though everyone is a perfect candidate for the procedure. There has been no lasting law to prevent them from continuing explicitly advertise as an equally safe choice as wearing glasses. While it might be safe for some, it is not safe for everyone! yet the advertising touts the safety and hype. One big operational hazard that allowed the mistake on my eyes to happen was the lack of attn to detail. My chart was not given adequate time for scrutiny or discussion. I was not alerted to the fact that my corneas were thin, or that this was an important variable for a safe procedure. At the time of my procedure, i was crammed into a room with 6 other pts and not given any personal time with the dr to ask questions. Medical history is a sensitive topic, and one that should not have been discussed hastefully in front of several other pts. I wish i had known that my corneas were thinner than normal, i myself would have objected to the operation. I have a separate complaint against the lasik plus dr.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1059500
Had lasik eye surgery. Lasik ruined my vision that has made life miserable. I had 20/15 clear vision anytime of the day with glasses before lasik. Now i have: severe starbursts in the daytime on all reflections. A starburst on an oncoming car is so bad that it blocks the whole car to where i can barely see the front bumper. Even more severe starbursts at night. Starbursts from cars block my view of the road. I have to use my hand to block the starbursts or i have a square piece of 3x4 inch duct tape on the windshield to block starbursts so i can see the road. Severe glare that makes it look like there's a fog around anything that is lit or white. The tv remote is white and has a glare around it sitting on oak table. Halos around lights at night and dim lighting. A frosted light bulb will have a halo and a clear bulb will have the starbursts. Severe light sensitivity. The sun reflecting on dry concrete hurts my eyes. Double vision and sometime triple vision. Dry eye that makes the problem worse. Night vision and in low light my vision is horrible. Low light is grainy photo. I have been on depression and anxiety medication since right after having lasik. Within 2 months, i lost 20 lbs right after having lasik because i couldn't eat. I am still on the medication today. The medication helps some but not completely, i can describe it as only taking the sharp edge of depression away. In the beginning, i went through 4 pairs of glasses of varying prescriptions to get by. Company had three pairs made and i had 1 pair made. I decided to have enhancements done because i felt i had no other choice living with this miserable suffering vision. Enhanced left eye 2007, right eye 2008. Vision focus improved enough to go without glasses but all the problems did not. Starbursts/glare got worse, vision fluctuates a lot. Before i had decided to have lasik, i asked the question to the consulting dr - be honest with me that i am definitely good to have lasik - she said yes and she did not talk about the problems. I told them that i want to see the same as i do with my glasses and they said i would be happy with what i see. Lasik plus lied, they told me the gash problems would go away, and they didn't. They told me my expectations were too high. Then they told me i just needed an enhancement. They lied to make money by ruining the only pair of eyes i will ever have. Lasik doctors have no integrity. I don't know how they can sleep at night after "lied to you", ruined a person's eyes and their life for profit. I went to a local eye dr and told him about my problems. He told me he used to work for company, and he said their corporate wants you to sell the lasik. He said he could have run off a lot of people. I asked him if he had lasik and he said no, he wears contacts. From one human being to another human being to not talk about and completely explain every detail about lasik and how it can ruin the only pair of eyes you will ever have is horrible and unbelievable. I am living a nightmare and i suffer every second because of lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1059460
I had lasik on both eyes in 2001. The first result was not good and i had one enhancement of my left eye and twice on my right eye. The right eye was still not fully corrected. In 2006, a regular eye exam found cataract in both of my eyes. It was worse in my right eye. In 2008, i had a cataract surgery for my right eye. I will have another surgery on my left eye at a later date. One of the eye doctors i have seen thought my cataract might be related to the lasik. If lasik could cause such side effect, this surgery should be prohibited or at least the dr should certainly let patients know the risk.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057417
Reporting of this complaint at this time is based on a previously filed serious injury mdr. As a result of that injury report, a 2-year reporting timeframe was initiated for all complaints of the same type. All complaint files for the ladarvision 4000 were reviewed for this type of event starting 2007. This mdr filing is a result of that retrospective review. A surgery database performance verification was conducted on this system and the analysis indicated the laser performance factors analyzed were operating within specification during the time of this pt's surgery. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary when add'l reportable info becomes available.
A nurse reports a pt with a possible decentered ablation. This report is for the right eye, the left eye is being reported under manufacturer's report number 1061857-2008-00094. Pt records were received and indicated a one line decrease in bcva at the 2 weeks post-op exam. The pt was slightly under corrected (-. 50 diopter) and exhibited a small amount of residual astigmatism (-. 50 diopter). The surgeon stated there was no pt harm/injury associated with this event.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057423
Reporting of this complaint at this time is based on receipt of a letter from the fda dated april 10, 2008 in which the agency informed alcon that complaint (event date: 2006) should have been reported as a serious injury mdr. As a result of that injury report, a 2-year reporting timeframe was initiated for all complaints of the same type. All complaint files for the ladarvision 4000 were reviewed for this type of event starting 2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: the technical manager (tm) was dispatched to the site to evaluated the device. The tm found an open heater element on the thyratron, replaced the laser chassis (which contains the thyratron) and completed a system verification. Mfg tested the laser chassis and verified the tm's findings, an open heater circuit on the thyratron which will cause the laser to not fire. Conclusion: based on the results of the investigation, the root cause is component related, specifically an open heater coil on the thyratron. This report mailed in to fda on: 06/06/2008.
A system operator reports the laser stopped firing at 23% into a procedure. The surgery could not be completed. Follow-up info from the system operator indicates there was no decrease in bcva, however, the pt started at -6. 00 diopter sphere and is now -4. 25 diopter. The pt will be re-evaluated in 3 mos. Follow-up with the system operator indicates the pt was re-treated on a different mfr's laser approx 3 mos following the initial procedure. Prior to the re-treatment, the pt exhibited a 1 line decrease in bcva. Additional info has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1058388
I had lasik done in one eye. For days post lasik i started to have recurrent cornea erosions and dry eye. I never had any problems with my eye before. The agony and pain i have experienced has meant that i have not been able to work and my life right now resolves around trying to lessen the pain.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057073
I had lasik surgery in 2006. I now struggle with severe dry eye. My dry eye symptoms began with lasik. At first, the dry eye symptoms were mild, but they have gotten worse over time. Now my eyes are constantly uncomfortable and sometimes painful. I am unable to read for long periods of time without pain. I am now searching for a treatment to fix the problem. Restasis and punctal plugs have not helped. I didn't check the 'disability or permanent damage' box because at this point, i hope the condition isn't permanent but i'm not sure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057106
I was damaged by lasik in my left eye in 2000, by dr. He finally admitted that i had a decentration and wrinkles in my flap, but that he didn't have the laser to fix the problem. I had to go to a specialist in another country, to try to get my eye fixed but it was damaged too bad and i had to receive a corneal transplant. Dr told me he would foot the bill or reimburse me for the surgeries that it would take to fix my eye, i believed him and never went to a lawyer. Once it came time to be reimbursed, he said he didn't remember saying that he would reimburse me, and my statute of limitations ran out. I never rec'd a dime from him. I had to foot the bill on this myself. I lost my house from these high surgery bills and now have to live with a corneal transplant because of this dr. Not one time over the years has he ever dropped a call or a letter to see how my eye was doing. This guy shouldn't even be a dr in my opinion. He now has a clinic in another country, and i wonder how many other people he has damaged since me.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057064
Adverse effects of lasik surgery on my eyes. I had lasik in 1999 in both eyes. I then had each eye "enhanced" several months later. In 2000, my vision began to deteriorate and has gotten consistently worse. I was diagnosed with severe keratoconus in both eyes due to the lasik. I am totally dependent on hard contact lenses and my vision will never get better. I will probably need a corneal transplant at some point in the future.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057091
Developed corneal ectasia after lasik surgery. Vision is now distorted and not very clear. I see long streaks from lights at night or in low light.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1056171
I had lasik surgery in another country in 2007. I chose this group because my sister had her eyes done there and was very happy with her results. At that time, i wore glasses for far vision, but i could still read without glasses. I went back for my checkup one day after surgery and then 1-2 week post-op. The one weak checkup was planned a few days early because i was experiencing pain in my left eye. The optometrist said, i had an inflammation in my eye and if it wasn't better in 48 hrs, i should a see a dr in the states. I decided on my way home to see an ophthalmologist immediately. The ophthalmologist said there was something very wrong and sent immediately to a cornea specialist. He did scrapings and put me on 2 types of drops. From there it went down hill. After not growing a culture on the first scraping, they kept me on antibiotic and steroid drops. Two weeks later, and a lot of pain, they did another scraping. This time they found a candida fungus. This meant that the steroids were helping the fungus grow, so i was taken off of the steroids immediately and put on 3 different antibiotic drops, one of which i had to use every hr, and at night every 3 hrs. One antibiotic was one hundred dollars a bottle, had to be kept cold and expired every 7 days. I had to see the dr either every day or every other day at first. During this time, i was trying to work but my eye was so painful, it was very difficult. One day my vision got so bad, it felt as though i was looking under water. I reported this to the ophthalmologist immediately and got an emergency appt. They found that the fungus ate a hole in my eye and it was leaking. I was to go home, not pick up anything over 5 lbs, and keep my eye covered while showering. They didn't want me to do anything. At the time of the surgery, i had a full time job and 2 small part time jobs. Now i had to quit one part time job and go on disability from the other jobs. Also, i couldn't be in any light at all, it was unbearably painful. I spent most of my days in the basement or a very dark room. I couldn't watch tv and i most certainly couldn't read. My visits to the dr were everyday now, even on the weekend, both saturday and sunday. My father had to drive me to and from the drs and i had to ride in the car with a coat over my head. There was talk about having to glue my eye, but the drs decided to wait to see if my eye would seal itself off. It did thank god, but the battle continued. I spent 5 mos on disability. The disability company wanted constant updates about my condition or i wouldn't get a check. During this time, my condition would get slightly better, then go down hill again. It was agonizing 24/7. By this time, i'm taking 4 different drops and a pill. I had to take 2 a day. This doesn't include all the co-pays, other medical bills, prescription costs and the fact that i'm now earning less than half my normal pay and have to pay for health benefits. My vision was never 20/20 after the lasik surgery and now it would get better then worse. My right eye remained about the same, but again, the best it got was about 20/30 to 20/40. Thank god i had some medical coverage. What i've told you so far is what it cost me financially and physically. Mentally, i was a disaster. I cried most of the time. I lost all self-esteem for many reasons. One, i chose to do this. I felt as though it was partially my fault. Two, my career of 26 yrs was in definite jeopardy. I'm an ultrasonographer. We spent all day in a dark room looking at a computer screen which is mostly black and white and have to measure things in millimeters. I couldn't read anything at this point even with reading glasses. The thought of losing my house was constantly on my mind. I've been a very independent person for a long time. I raised 2 children completely on my own. Now i had college expenses i couldn't pay. I've never had to take a hand out from anyone. Now i had to depend on my elderly parents to do everything for me and i had to constantly fight with the disability company for every dime they sent. I thought that i would have to move in with one of my siblings in order to survive. It was the absolute worse time of my life. The thought of ending it all was not far from my mind. Very slowly i got better, with the best care i could ask for from the corneal specialists, and the kindness of their staff. When i went to my appointments, i was in tears and had to hold an icepack on my left eye most of the time. The staff would keep the lights down in the room, so my eye would not be so painful. In late 2007, i went back to work part-time and eventually full time. I still have trouble with my left eye. I've had 3 different prescriptions. Non of them work well. My left eye has shadow vision, or double vision. There is a scar in it. The ophthalmologist said that might get better, but it constantly feels like there is something in it. Both eyes need correction for both near and far vision. My night vision is terrible because all of the lights smear. I can't even enjoy looking at the moon or stars because it's all a smear. I have an appt tomorrow with lasik md approx one yr after surgery. They have closed the clinic, so now i have to drive to another city, a two hr plus trip. They have all of my records because i had everything faxed to them during this disaster. I'm not sure what i'm going back for. I just know i need to go. As far as i know, i did everything by the book and there were no errors that i know of elsewhere.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1056867
Model Number INTRALASE
I had lasik surgery about a year ago and now i'm experiencing "starburts" and glare at night. I had the surgery done by a very well recommended surgeon, so i didn't 'cheap it off'. The starbursts are getting worse and worse but seems to go away a little when i use lubricating drops. Please stop people from having the surgery done until they've worked all the "kinks" out of it. People are having their vision damaged. Dates of use: 2007 - 2008. Diagnosis or reason for use: terrible vision. Saddleback eye center. F: lasik surgery requires that the patient take too much responsibility for their healing. Please stop this procedure until it can be perfected!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057092
This is related to cosmetic eye surgery. I considered lasik for awhile, but was afraid that my eyes were too dry. I didn't really use any drops during the day, but it was when i could feel that they were really dry, that's when i occasionally would use drops. Finally after 3 years i decided to go see a lasik specialist for advice. Two places that i went to did not event check to see if i had dry eyes. The doctor just looked at my eyes and said they were fine. I was not satisfied with their answers. I finally decided to go to an eye institute for a screening because i heard a lot of good things about them. Even if they charged a lot more, i was willing to give them a try. On my first appointment, dr determined that i had dry eyes, therefore, put me on antibiotics and fish oil. She also suggested prk instead of lasik for me, because there will be less nerve damage to my eyes making it less dry. I was very happy because this was the first place that i felt cared about my eyes. I was on it for 1 month, when i came back for another check up, the doctor said there was improvement, therefore, i can go ahead with the surgery. Before the doctor decided this, she had her assistant measure the dryness of my eyes with some kind of camera. They had to take the pictures may times, because my eyes were too dry, therefore, the camera could not get a good picture of my eyes. I was a little bit hesitant, because my eyes only felt a little better, but trusted that she knew what she was talking about, since she seemed to care a great deal about my eyes. She asked me to continue the antibiotics and fish oil after surgery, she said it should continue to improve even more. I was very excited to hear that. The doctor that operated on my eyes was another doctor. The next day after surgery, i was required to come back in for a check up. When i did, the assistant mentioned that my file said i got lasik not prk, i was very nervous and confused. I went in thinking and also signed paperwork for prk. Then dr mathers came in, but he was also confused on what i got done, finally they figured it out by looking at my eyes through a microscope. Prk has a different kind of surgery mark than lasik. I was so scared starting that moment on, i wasn't sure anymore about this place. These were my eyes they were dealing with! four days later, i came back to get the contacts taken out of my eyes, they didn't even know what doctor i was seeing. Dr mathers was on vacation, therefore, i was to see his assistant doctor. Two different ones came in before they could determine which one was to see me today. I was so angry, another mix up, by now i was really scared and didn't trust this place anymore. When the doctor took out my contacts he accidentally poked my eyes. I was shocked, because i thought he should be good at this by now. From then on all my follow up appointments was with third dr. He was not very organized, every time he came in the room he would ask me why i was here. He would never remember what he recommended for me from the last time. For example, he asked me to start taking 4 pills of fish oil instead of one, he forgot that. He asked me to continue to take my antibiotics and plus he added restasis eye drop to my daily routine and he forgot that. I always had to update on what he asked me to do last time. It was horrible. I don't think he even looked at my file before he came in. Well, after surgery, my eyes dryness level got worse. I was putting in eye drops every 5 minutes. When i came in to see him, he boosted my fish oil intake and recommended other brands of eye drops. He also gave in an inflammatory drop, that helped. I started doing eye drops every 15 minutes. I was still very frustrated. When i came in to see him, he would tell me my eyes look fine and didn't really do anything else for my dry eyes except to tell me to continue my antibiotics, fish oil and restasis, even though i kept telling him it has not helped me any. After changing to refresh celluvisc eye drop i was able to wait every half an hour to put in drops, that was a relief from every 15 minutes. When i woke up in the morning, my eyes felt like there was sand in it. I could never open them, therefore, i started using a night time ointment. I never had to do this before the surgery. I was very frustrated and angry at the fact that this was not told that my eyes will get this dry and there's really no improvement and the doctor is doing nothing about it. My contract says that after surgery they will see me for six months to monitor my eyes. Every appointment i had after surgery with him was pointless. He kept telling me my eyes were fine after looking at it through his microscope. My last appointment was at my 6 month post operative exam. They measured the level of dryness for my eyes again with their special camera, it came out very dry. I figured since my eyes were still really bad he would continue to see and help me get better. Instead he said that since my eyes were dry to begin with it was not the surgery that made it worse, i was so angry when i heard this. I hardly used eye drops before the surgery. Now i am doing it every half an hour and it's not the surgery then what is it? not only is it annoying to put in eye drops so often, but it's very expensive. He said he will send all paperwork to my regular doctor so i can continue my treatment there. I feel that this doctor did not really care about me. He just wanted to push me out of the door. I am very unhappy and still doing eye drops every half an hour after 9 months of surgery. I still have to put thick ointments in my eyes before going to bed otherwise, it would hurt to open them in the morning. I want to let others know, so they won't go to where i went. The eye institue. Dates of use: 2007 - 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1055489
I had lasik performed on both eyes in 2005. My surgery was done by a dr. I wanted lasik because i was no longer comfortable wearing contact lenses. I was not tested for dry eye or warned of the link between contact lens intolerance and dry eye. I was also not warned that a pre-existing dry eye condition would put me at a higher risk for developing permanent dry eye after surgery. I was handed my informed consent form with the words "read this, but don't let it scare you, this stuff never happens. " immediately following my surgery, i began having pain in both eyes due to severe dry eye. My lasik clinic offered very little help, and when i was able to get visits with my surgeon -instead of the regular post-op care dr-, he would spend about 2 minutes with me and rush me out the door to perform his next "assembly line" lasik procedure. I have seen over 10 doctors, tried most conventional dry eye treatments, and spent thousands of dollars in the process trying to get relief from dry eye pain and discomfort. I continue to spend over $100 a month on drops, gels, and other treatment methods to help with my condition. That said, i am still always uncomfortable and often in pain due to my lasik-induced severe dry eye. My dry eye symptoms have impacted all aspects of my life and affect me every waking hour. The first year after my surgery was complete torture. I suffered from severe depression and panic attacks due to the physical pain and guilt that i felt over having elected to have lasik. I never had a problem with anxiety or depression prior to my lasik outcome. A 15 minute procedure that was supposed to make my life easier, has now greatly decreased my quality of life and has complicated it more than i ever could have imagined. I will face a lifetime of eye pain and problems due to my lasik outcome. I cannot express in words the pain and sadness that lasik has caused me and those closest to me. I try to keep hope that someday a new drug will come out that will help me, but until that day comes, i will continue to battle eye pain and the altered lifestyle that i have been forced to accept under these circumstances. I am unsure what laser was used to perform my surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1055498
I rec'd bilateral lasik with the alcon ladarvision 4000 sys. The treatment was wavefront guided utilizing the custom cornea software. A bd microkeratome with 180 micron head was used for flap creation. The optical zone used was 6. 5mm with a 9mm total ablation zone. Preoperatively, i was od: -5. 5d and os: -5d with. 75d astigmatism. My scotopic pupils were measured at 8. 3mm. Ever since surgery, i have suffered from large starbursting and halo under low light conditions and reduced low light contrast sensitivity. The bottom line is that i was not a candidate for refractive surgery in the first place: i was lied to and sold the procedure by my dr and his staff. The optical zone must be large enough to cover the scotopic pupil for surgery to be allowed, end of story. Why dose the fda continue to allow such dangerous and deceptive practices by refractive surgeons? it should be a contraindication for surgery if the scotopic pupil is larger than the proposed optical zone for the device. These visual disturbances are quite disturbing and dangerous for activities such as night time driving. They are very bothersome for any activity conducted in low light. Finding things in low light is much more difficult post surgery due to the reduced contrast sensitivity. The most blatant violation was treating me with an insufficient oz size, but other damages have resulted as well. I have corneal irregularities within the oz: central islands, as revealed by corneal topography scans. The alcon sys have been known to cause these complications; as such, they are dangerous devices and should be taken off market until these problems can be proven through testing, to be resolved. Another damage i have rec'd is high increase in floaters. These are caused by posterior vitreous detachment. Microkeratome suction rings are dangerous devices that create high intraocular pressures and stresses, causing damage to ocular structures like the vitreous humor and retina. As such, they should not be allowed. There are much safer, reliable surface ablation procedures for refractive surgery that do not involve microkeratomes and flap creation. The lasik flap never heals and remains as a life long interface. This leaves the cornea permanently weakened and vulnerable to trauma and flap dislocation. How does this permanent damage benefit the pt with previously healthy corneas? i was 19 at the time of surgery. The fda approval order for the ladar vision 4000 sys clearly state that this device is only indicated for use in those 21 yrs of age and older. I was not informed of this. In fact, my informed consent was highly insufficient. I was not provided a copy of the pt information handbook for the device, which is required to be given to prospective pts - as specified by the fda approval order and the operator device manual-. The pt info handbook contains studies and clearly outlines complications and their percentage of occurrence and also warns about scotopic pupils larger than the 6. 5mm oz. My informed consent contained no info about the risk for surgery due to my large pupils or the risk for vitreous detachment and floaters. The clear differences in safety between lasik, lasek, prk, etc. Were not presented so that i could make an informed choice on the type of procedure to choose. The summary of this complaint is as follows: the optical zone must be at least as large as the scotopic pupil. Surgery conducted outside of this is dangerous and visually damaging to the pt. A clear standard of care needs to be established for pupil size. Alcon devices have been shown to be inferior devices with comparatively high complication rates, particularly relating to central islands. The should be banned, investigated, and corrected before use is allowed in the future. Lasik is a dangerous procedure due to microkeratome flap creation. Surface procedures need to be advocated as safer alternatives. Strict guidelines regarding device use and reporting of complication need to be set and enforced. Success rates need to be based on what the pt deemed a success, not the dr. The pt is the one who has to live with their vision. Informed consent needs to be far more detailed and standardized for refractive surgery. Dates of use: 2007. Dianosis: correction of myopia.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053753
A pt reports following lasik surgery, he is experiencing floaters, glare, halos, severe starbursts and dry eyes. The pt stated the floaters make it, 'difficult to see' and he is having trouble driving due to the starbursts. The pt wa seen by several drs for second opinions. One dr mentioned corneal imperfections and flat corneas. The pt indicated he had done some research and found out about central islands and thinks that is what the corneal irregularities are. This report is for the left eye, the right eye is being submitted under mfr # 1061857-2008-00081. The surgeon who performed the lasik procedure on this pt indicated the pt did not have central islands and has not been harmed or injured by this event. The surgeon declined to provide any pt records. Pt records were provided by one of the drs the pt saw for a second opinion. The records indicate at 4 mos post-op bcva in the right eye was 20/15; left eye was 20/15-2. Ucva in both eyes was 20/20. Pt has peripheral vascular disease.
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when add'l reportable info becomes available.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053952
Initial lasik surgery performed in 2003. Two weeks after surgery, i experienced blurred vision & shooting pain in the left eye. From there i have five corrective surgeries. I've been to four different corneal transplant specialists. I am now facing a corneal transplant, but the only problem is that the cornea will be repaired but the pain from the nerve damage is irreparable due to numerous surgeries. Now my only relief is to apply ointment & tape a gauze bandage to it to get the eye toned for the following day. I struggle daily with side effects like constant eye pain & other overwhelming side effects. This has taken a toll on my emotions & quality of life. For me, not a day goes by without wondering how much worse the pain level can become with no medication for relief & also the future cost incurred by this can become an issue.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052127
Pt reports that she was not informed of the side effects of the prk surgery states that five hrs after her surgery, she experiences intense pain. She now has extreme dry eyes, has to close one eye to drive because of halos. Pt states that she has to wear glasses to see, however, the glasses makes her nauseated. The office where she had the surgery promised to send her a pair of glasses and has not as of yet.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1053909
In 2003, i underwent lasik surgery using the ladar laser for severe hyperopia and astigmatism at the eye center. I was told i would at least be seeing 20/40 the next day, which was not the case. After going through several pairs of glasses and several months, my vision finally settled. I cannot, however, achieve 20/20 in my right eye anymore with glasses. I can't wear contacts because my eyes are too dry now, and i can't tolerate the hard lenses. I have had problems with halos and starbursts since surgery, and they continue now, 5 years later. I now also have a problem with some mild ghosting in my left eye with certain lights. I also lost contrast sensitivity as a result of the procedure. I do not drive at night unless necessary because the oncoming headlights obscure the road. I did not read and sign a consent form until after they had taken my glasses and given me ativan to calm me for the procedure. During the procedure, dr had a problem while using the laser on one of my eyes because i could not hold my eye still, apparently, and he kept telling me over and over to hold my eye still. Not so easy when he's yelling and i'm nervous as hell as a laser is burning off part of my eyeball. I just want others to know and understand the risks associated with lasik surgery and for these money-hungry doctors to be more open about the risks of this elective surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052128
Pt reports that after having laser/lasik surgery on both of her eyes, she can no longer see and this has caused her not to be able to obtain her driver's license.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052885
Patient had lasik surgery in 1999-?-. In 2006, noticeable decline in vision quality sudden began. In 2007, patient was seen again by surgeon. In 2008, patient was told he had cone shaped corneas and should be enrolled in the fda trial. No other recourse was offered. Research dept's packet strongly insinuated that the lasik was the cause of the now degrading eyesight. Patient requires glasses once again and vision is constantly changing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052136
I have heard that the f. D. A. Is investigating lasik surgery and is interested in pts that have had unacceptable outcomes from lasik surgery. I had lasik surgery on both eyes approx ten yrs ago. Prior to surgery, i was extremely nearsighted. The surgery overcorrected my vision. In 1999, i went to another country for lasik to correct the now farsighted condition. I had surgery on my right eye at that time. The vision in my right eye is permanently distorted following that surgery. I was told that my condition was a "fluke" and they had no idea why my eye did not heal as expected. I now wear rigid contacts which corrects the irregular surface of my right eye and the farsightedness in my left. My uncorrected vision is improved from the original condition but not well enough to drive or do everyday tasks without contact lenses. The laser ctr.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052221
In 2001, i had lasik, first on one eye and then on the other eye one week later, at a clinic. I have struggled with dry eye ever since, ranging from mildly to severely annoying. Despite having tried punctal plugs, daily hot compresses, and doxycycline therapy, my meibomian glands have never returned to normal function. Of course, i have since learned this is considered a 'minor' lasik 'side effect', most likely due to the permanent nerve damage wrought by the microkeratome -hansatome- and excimer laser -visx- devices your agency has approved for medically unnecessary purposes. I observed my first floaters--signs of a posterior vitreous detachment--within weeks of the lasik surgery - reported september 2001. This i have learned is due to the high pressure caused by the suction ring used with the microkeratome, which your agency has approved for medically unnecessary purposes. I noticed double vision symptoms, especially at night, soon after the surgery. I was relieved in 2002 that i was able to get a prescription that seemed to relieve these symptoms. However, over the next several years, i went in for several more prescriptions, each proving a bit less satisfactory than the last. Finally, in 2007, i was diagnosed with post-lasik ectasia, as my corneal topographies showed the trademark sign of inferior steepening, which accounted for my increasing cylinder and increasing symptoms of double/multiple vision. I have thick corneas, had stable refraction for 2 years, and measurements of flap thickness with an artemis device showed no signs of a too-deep flap thickness. In other words, i was a 'perfect' candidate, whose preoperative topography -which showed ~0. 5 d of inferior steepening- would probably not be turned away today despite the new 'stricter' guidelines being suggested. The reality of course, is that nobody is a good candidate to have their corneal strength weakened by a third by a microkeratome, for no medically indicated purpose. However, this butchery remains approved by your agency. The reality is that keratoconus remains poorly understood. At this point, i'm still -barely- correctable to 20/20, so by some accounts i'm 'normal', despite the fact that one can see 20/20 -or 20/16- with significant irregular astigmatism that is anything but 'normal'. This has been known in the keratoconus literature for years. Yet your agency continues to employ outdated visual acuity measurements as the 'clinical outcome' measurement for approving devices. This is convenient for the doctors, especially so because '20/20' has been popularly misunderstood as 'perfect' vision, when it is anything but. In the last several years, i have read with interest about 'wavefront-guide' treatments, with an interest in reducing my irregular astigmatism. I have been shocked and appalled to see that devices marketed as being effective in reducing higher-order aberrations have actually shown no data to this effect, whatsoever. In fact, they merely reduce the amount of induced higher-order aberrations. They have reduced hoas in patients with initially high levels, but the reductions have been small. It's shocking that devices known to increase higher-order aberrations / on average/ are approved for general use. Should not people be warned that their hoas--their quality of vision--/ will/ be reduced? -though maybe not enough that they'll notice or care. Now i am considering a topography-guided ablation, as this is the only approach that has some track record of consistently reducing irregular astigmatism and hoas by significant amounts. Indeed, several doctors in another country have now several cases of improving forme fruste keratoconus patients' best-corrected vision. However, your agency has not seen fit to at least give humanitarian approval to the laser refractive surgery devices that /do/ have a record in reducing irregular astigmatism -e. G. The suite from ivis technologies and/or the topography-guided options from wavelight-, which is a legitimate medical purpose for refractive surgery. This of course would not be lasik, but rather surface ablation. It is unclear why lasik remains approved today despite the mounting evidence that surface ablation is much safer biomechanically. So i will have to leave this country, and visit europ instead, to have a chance to improve my vision and likely also do corneal collagen crosslinking, which was kept a well-hidden secret from us patients -frequently along with their ectasia/keratoconus condition itself, as doctors frequently don't diagnose what they can't effectively treat- for many years, by your agency. Ironically, i have been funded by the dhhs -nih- in the past, during my phd work. I work as an optical engineer, developing adaptive laser scanning systems for neuroscience research. I've developed a cutting edge system, and might well have moved towards consideration for future nih funding, including the pioneer award. Of course, now it's difficult to work in the dark, so my scientific career prospects are significantly diminished. I am able to work for now under private funding. So, do consider that your agency's behavior has not only been reckless, but counterproductive. I hope you're ashamed. Dates of use: 2001. Diagnosis or reason for use: good question! nominally a 'disease' called myopia.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052147
Following lasik surgery, i have experienced severe dry eyes and fluctuating vision throughout the day as my intraocular pressure changes. My vision fluctuates between approx 20/60 - 20/120, requiring me to wear two different pairs of glasses depending on the time of day.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052148
The date of the "event" is the moment of realization of the problem, not the date the lasik occurred. I had lasik performed about 10 years ago by a dr. My vision was excellent immediately, but began deteriorating and i went in for a redo on one eye a little over a year later. My vision continued to decline and i learned, it was not correctable by glasses. I realized a few years ago that i was seeing triple, but didn't know why. I didn't put it together with lasik until 2007 surfing on the internet. The medical forum talked about a pt whose triplopia was caused by lasik. Then i met an optometrist who was familiar with triplopia. He examined me and confirmed he couldn't do anything. He suggested getting legal representation but i don't have the money to do so. He told me i will not be able to pass a dmv eye chart exam. I didn't think there was anything i could do. Then my daughter heard on npr that the fda is looking into lasik issues and that's how i got here.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1052143
Lasik surgery on both eyes. Problems: evaluation for candidacy did not include a thorough explanation of the effects of substituting distance vision for close vision in an older person. I was told that i would probably need reading glasses. Before the surgery, i was able to take off my glasses -which i had worn for myopia since age 8- and see up close. I was able to read, to put on makeup, to cut my toe nails, to see faces up close, to work on the computer - in short, the vast majority of activities that one does. I could not drive without my glasses or see distances. As a result of the surgery, i could drive and see distances, but 99% of my daily activities were now no longer available to me without reading glasses. In addition, i could not see as well with the reading glasses. I wore progressive lenses before; i wear progressive lenses today. Eight years later, i am still angry and mourn the loss of my vision every day. The issue is whether i was an appropriate candidate for this surgery in the first place.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776
I had lasik surgery in 2001; a year later, my vision had worsened, so i had to have it again; to this date; i cannot see anything without rigid gas permeable contact lens that i can only wear for 8 hours a day; i'm literally blind without these glasses; i only wish i'd never gotten this surgery, because glasses don't even work. I'm really sad and depressed about this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078775
I had lasik surgery in 2002. In 2008, i was advised i could have lasik enhancements because my vision had changed. I now have moderate dry eye in one eye and extreme dry eye in the other. I also experience severe pain and discomfort when i try to read, watch tv, look at a computer screen, or anything that requires me to focus. My eye surgeon has placed a permanent plug in my tear duct. I use eye drops every 30 minutes and get very little relief. It has made my life miserable. I went to a cornea specialist last week. He suggested taking fish oil and other multiple vitamins in hopes of making my eye better. I was not explained the possible complications by my eye doctor, and if i signed a consent form, it was just the same day and just prior to the enhancement procedure. If i had known the possibility of the severe dry eye, i would have never had the procedure done. I am very upset with my doctor!!!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1077192
In 2008, i underwent lasik on both eyes in the offices or dr. The next day my vision was very blurry and i went back to dr and was told that my flaps were too thin and that i would need an enhancement surgery, but this may not correct the problem. When i asked why this happened, i was told that, "it is just medicine" by dr. He also asked the equipment mfr why all the machines told us i was the "perfect candidate" for lasik and then this happened. They also had no response. I believe the maker of the equipment is nadik. So now i have gotten 3 second opinions and all agree that it may be fixable with add'l ptk surgery, a yr of treatments.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075511
Lasik complication. Following a lasik procedure i developed inflammation and central toxic keratopathy -ctk- resulting in severe hazing across the cornea, arge straea, and a blistering of the epithelial layer. Betadine was administered even though i reported an allergy to it. Hazing cleared, but halos in day time reflections and night time lights are prevalent in both eyes. I am now 4 steps farsighted -was 3. 5 steps near sighted- in one eye. Irregular astigmatism persists causing ghost images and fuzzy vision. I believe this to be a permanent condition after nearly 2 years.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075441
The military used prk corrective laser eye surgery on both of my eyes, and my vision in my right eye has become blurry. I have difficulty reading emails on my laptop and cannot read the powerpoint presentations during class. At night, i see starbursts around lights which has made driving dangerous under these conditions.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073789
Starburst and night vision problems since lasik eye surgery. Starburst began immediately after surgery and never subsided. Vision seems to be getting worse. It was a rare family history of glaucoma. Lasic surgery tlc laser- whitten.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1074478
I had lasik eye surgery and have suffered numerous side effects in my vision. Including a loss of peripheral vision in both eyes, floaters, regions of depressed sensitivity in day light vision. Night vision has degraded significantly and my vision has a yellowish tint. In addition, i require daily eye drops for dryness and get flashing migraine headaches on occasions. I have extreme difficulty reading, and can not do technical work anymore. I deal with eye pain and eye strain daily. Additionally, my eyes are very sensitive to sunlight. Now i just go to college and live off the proceeds of my house. I am also registered with the learning disabilities center as visually impaired. Yet, my eye dr says my vision is 20/40 and i am fine. I still need eye drops for dryness 2. 5 years later. Additionally, i feel that my eye dr who did the lasik procedure is not being truthful with me and i have to pay for this checkups every six months for the rest of my life. I am getting ready to apply for disability.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075348
Post operative data of a pt treated with the wavescan revealed an over correction of +2. 00 diopter in the right eye and +3. 00 diopter in the left eye at one month following treatment. Pt also is experiencing dry eye. Patient's best corrected post operative visual acuity in both eyes is 20/20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1073784
Lasik eye surgery has caused me severe pain, damage and trauma. Every day of my life it consumes me. Every day, all day, my eyes are dry, sore and in severe pain. I use expensive eye drops and they only provide a split second of relief. It is painful to do my favorite activities, such as reading. It is painful to do my job as i work from a computer. I am scared to go swimming, to the beach, or snowboarding because they may only irritate my eyes further. I can not go outside without sunglasses. I no longer think i can go back to school because reading is so painful. It is painful to sleep and painful to wake up. All day i live in complete misery. I am only 24 and am sad every day because i realize my life has been ruined from this surgery. Today i saw someone wearing glasses and was wholly consumed with envy. I wish i could wake-up from this nightmare. I'm scared and have little hope. I don't want this to happen to others. Thank you for taking the time to read this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069870
I underwent lasik surgery in late 2005. I have dry eye complications from that surgery. I heard through the news about the fda hearing today and was dismayed at the fact that only 140 complaints were made. I need to know what i should do to let the fda know about my complications. Please provide me with instructions. I am desperate to have the lasik industry changed to protect future pts. (as a side note, i was a healthcare admin for over 10 yrs, and before that a scientific researcher- so i was a little appalled hearing that less than 1% of lasik pts have complications- there is much research, websites, etc. That prove otherwise). Your advice and direction will be greatly appreciated.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069871
I was eger to share my experiences once i found out about this hearing. In 2000, i had lasik performed. In 2007, i began having sensations of sand in my eye or sometimes, when very dry, glass in my eye. It was very painful. I also had photophobia, and could not look at the computer screen (i need to use for my job) or the television screen without eye pain. Also, it was difficult to drive - in some cases, when i would administer eye drops when my eyes were dry, the drops would turn to almost a gluey consistency, and it was difficult to see - somewhat like looking through wax paper - not good for driving. This condition took over my life for the next yr, while i went from dr to dr in search of a solution to the pain and discomfort i was experiencing. Some drs said this condition could not be linked to lasik, because it didn't occur until 7 yrs post-lasik (interestingly, these drs also had lasik practices). However, 2 of the ophthalmologists i went to (including two drs of the eye center affiliated with tufts) did feel it was due to lasik. I now have the boston scleral lens and it has helped me tremendously.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069872
I don't know if the fda addressed the issue of inaccurate intraocular eye pressures and intraocular lens calculations in post refractive surgery pts but this had become a real problem. I am a board certified ophthalmologist (cornea specialist) who performs lasik and prk as well as cataract surgery. What most refractive surgeons omit telling pts is that refractive surgery changes the curvature and dynamics of the cornea. This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult. If the preoperative, operative and postoperative info is available, it can be used to better calculate the true intraocular pressure and implant power. Most refractive surgery pts are in their 20s and 30s but glaucoma and cataracts don't become problems for decades later. By this time the medical record is lost or unavailable. To help address this issue, i have started a web-based refractive surgery database where pts or their refractive surgeons can store this info for further use. The website also provides info for pts and contains an extensive list of references regarding this issue. Whether pts use this database or not it is important that they obtain their medical record for safekeeping. Please feel free to contact me with any questions you might have. Thank you for your time and consideration.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069873
Lasik 2007. Severe dry eye since, burning, unremitting pain, 4 tear ducts plugged, blood serum drops, artificial tears, restasis, depression, post traumatic stress, on work disability since 2008. This experience has been beyond traumatic. They should ban this procedure if beforehand, there is no way to determine if you will get this. I had no previous history of dry eye or any underlying conditions.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1071085
I am reporting a problem with my lasik surgery. I was told by the doctor that lasik had a permanent effect. That was not true in my situation, i had monovision and had a dramatic decrease in the vision of both eyes 5 years after my surgery. The doctor still has info on his web site that the procedure is permanent. I ended up having the procedure done again at great expense. I would have thought twice in the beginning if i had known that there was a possibility of it not being permanent.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069890
I underwent lasik surgery to correct farsightedness. I was initially corrected with monovision. I was unable to see clearly from that day on. I was told that it would take time for my eyes to heal and make the adjustments for the monovision. So, i waited patiently but the vision did not improve, instead it only got worse. In 2007, i was given an enhancement to "delete" the monovision - that is what the practice called the procedure. I had explained on numerous occasions that i felt something had gone terribly wrong. I was given the same song and dance every time i called in. When the flap was being cut in my right eye they stopped mid procedure and started again without explanation. I was told that this is no cause for alarm, but i am hesitant now to trust anything they say or do. I am left with scar tissue on my right eye that extends from the mid iris area to the edge of the pupil and a little bit beyond. My distance vision in both eyes was excellent before the procedure. Now i am left with blurry vision in my left eye and my right eye is similar to looking through a kaleidoscope. It is always very dry and painful, even though i put drops in as directed. My night vision requires such a heavy prescription that it distorts everything around me, causing me to fear going out at night. My right eye no longer opens completely because of the sensitivity to light and dryness. The depression following this event has been the most devastating event in my life so far. I am not sure where to turn for help, and am unable to think clearly to even follow through and get some help. When i call around for a second opinion i am told that i need to keep seeing my original surgeon, and that makes no sense. I can tell that my eye is getting worse, and i am certain that one day soon i will be unable to see at all with my right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1068318
Initial, bilateral, lasik surgery w/summit apex plus excimer laser for moderate myopia both eyes w/mild astigmatism right eye. Within 4 months, vision was 20/200 bilaterally and blurry vision, halos, starbursts and dry eyes experienced. In 2000, bilateral surgery performed utilizing ladarvision to correct residual myopia and astigmatism. At about 8 months later, surgery performed on right eye utilizing ladarvision to correct residual myopia and regression. In 2001, surgery performed on left eye utilizing ladarvision to correct residual myopia and astigmatism. The surgery(ies) resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts, loss of contrast and has made a negative impact physically, psychologically & financially. (see scanned pages).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1067436
I had intralase, followed six months later by an "enhancement" with lasik. I had been told i was a good candidate and any risks were described as very minimal. Problems were evident immediately afterward and i was told repeatedly they would clear up. Several years later, while i have decent acuity, the quality of my vision is poor. I suffer from issues with glare, light scatter, see ghost images, halos and starbursts during the day. At night, i am almost blind. I lost much of my ability to function in the world and am also depressed and filled with remorse because i made the choice to have this surgery. Yet, i imagine, i am characterized as a success because i can read an eye chart from across the room. At my last appointment with the physician who did the surgery, he said, he remained terribly puzzled about my eyesight, acted almost as if he didn't believe me, and said, "well, there's a lot we don't know about eyesight. " if that were the case, i can't imagine why this surgery is marketed so heavily.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066827
A system operator reports a pt with overcorrections following bilateral refractive surgery. This report is for the left eye, the right eye is being reported under mfr report #3003288808-2008-00002. Pt records were received and reviewed on may 28th. The corneal flap was created by intralase and the pt received a conventional hyperopia with astigmatism treatment with a planned monovision outcome. At 1 month post-op, this pt was overcorrected by -. 75 diopter in the left eye. The left eye also exhibited a 2 line decrease in bcva. The surgeon was contacted on june 10th to obtain data on the pt's current status; however, the surgeon indicated, he was unwilling to provide additional info, stating there was no harm to this pt.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1066036
Result of lasik procedure: left eye now has blurry vision, double vision, halos, starbursts, epithelial ingrowth, floaters, dry eye. Vision both near and far uncorrectable with glasses. Right eye: double vision, halos, starbursts, floaters, dry eye. Distance vision correctable with glasses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064755
This letter addresses my concern about the safety of lasik surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on lasik, i decided not to do the surgery. I believe lasik surgery is not consistent with the ophthalmologist's hypocritic oath of "first do no harm. " statistics on complications could easily be manipulated by surgeons and i don't think their reporting of complications can be relied upon. I think a few points are more valid: it was reported in the last year in the literature that lasik surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the lasik flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When i have explained this fact to hundreds of patients who were considering lasik, everyone stated that it is enough reason not to do the surgery. I explained to them that it's as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won't do the surgery. When i have seen patients that have had lasik surgery with other doctors, none of them were aware of this fact. We are playing russian roulette with these patients, hoping statistically that they won't be hit in the eye. We are also playing this roulette game hoping beyond all hope that they don't get infection, but we all know infections happen. I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are lasik surgeons, why aren't we more concerned about the damaging effects of lasik which causes dry eye and damaged corneal nerves. They elected not to answer the question. I think we have a panel already in this country that is ideal to give you the answer to the problems with lasik. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don't do this surgery and ask them why they don't do it. I have seen other examples of where the fda allows higher risk manipulations of the eyes when it clearly is against the patients' interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence. The three examples cited in the letter, i. E. , lasik surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a "wow" factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over "first do not harm".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064265
Received lasik surgery in 2007. Since surgery i have had much trouble adjusting to new vision including loss of near vision that was not a factor previously, even with glasses -pre-surgery- on for nearsightedness. This effect was not explained to me before surgery. I experience ghosting in both eyes, more severely in right eye. Both eyes experience starbursts, daybursts, halos, and glare. I experience double vision when i look to my extreme left that i did not have before surgery. I have had a noticeable increase in floaters in both eyes, but especially severe in the right eye. Both eyes are noticeably drier than before surgery. I never had any dry eye before lasik surgery, not even once. Distance vision is noticeably not as clear and sharp as before surgery with glasses. Overall vision is significantly reduced and less functional than before lasik surgery. Overall quality of life is significantly reduced as i have experienced and continue to experience digestive issues and psychological disturbances that directly coincided with lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1064245
I had lasik surgery and since then i have not been able to work for more than a half a day. I see double at times. My vision goes blurry and then i can't see up close or anything in the distance. I can no longer drive at night because of the halo effect. In low light areas, i strain my eyes so hard that i have pain. I had mono lasik and it has completely screwed my life up. My doctors office which is the lasik vision institute keeps telling me that i have extremely dry eyes and that it will clear up, but i have had no improvement and it seems to be getting worse. This could ruin my career and my life. When they tested my eyes before the surgery and found out how dry my eyes were, they should have turned me away, or at least informed me of the serious problems that were occurring because of dry eye syndrome. I am paying for surgery that has ruined my life. I don't know how the fda can continue to let these doctors perform this surgical procedure that ruins peoples lives. I am devastated over this and don't know what i am going to do.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134043
I had bilateral lasik eye procedure to correct distance vision. I awoke the next day to find that i had 20/20 distance vision, but i had lost my near vision. That was not the case prior to surgery and i do not remember being specifically warned of that possibility. I also developed dry eye, floaters, halo & glare that i was told would go away within a few months healing time. They did not. I also was not offered the option of only having one eye done at a time or was the option of monovision correction offered. I am an ultrasound technician by trade and i depend on being able to see near/computer and now i am burdened with having to wear glasses and having to pay off a huge amount of loan because i didn't want to wear glasses in the first place !! diagnosis or reason for use: improve distance vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1134023
Severe dry eyes from lasik with wave technology. For therapy, currently using nocturnally heavy lubricant eye ointment of 41. 5% mineral oil, 56. 8% white petrolatum with eye mask to preserve humidity. Daytime use of lubricating eye drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1128165
Permanent visual problems resulting from lasik procedure. I was 20/20 with contacts prior to the procedure, and had no eye problems. I now suffer from higher order aberrations as well as dry eye. I have lost my best corrected vision and can no longer wear contact lenses, due to discomfort. This procedure has severely impacted my quality of life.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125904
In 2008, i was undergoing a lasik procedure. The doctor had just started the procedure on my right eye. The first part of the procedure required the use of a microtome cutter that cuts a flap in eye tissue to expose the cornea for the laser treatment. However, in the process of using the microtome, i experienced sharp very intense pain, the doctor made a comment like - "oops", or "oh know"- he explained that "i have to stop, i cannot do laser on you just now, we must do it later-, he then said that he needed to allow me to heal and that i had to come back the next day -friday- and saturday so he can see the healing. On friday, i was seen by another dr. He looked at my eye and i asked him what happened the day before, i also told him, that during and after the procedure, dr never told me what happened and since i was sedated during that procedure i was not thinking clearly. Friday, i asked this other dr what happened. This dr. Told me that dr. Had cut or nicked my cornea. I told him my eye hurt and i could not see out of it. Dr. Said that dr. Wanted to look at my eye on sunday. I am reporting this because i am a former bio medical engineer with experience investigating pt device failures. I will be seeking medical help from insurance co. Next week, however, medical literature shows that cornea cuts, and abrasions often leave permanent eye damage, i have been in much pain for two days, i am shocked and dismayed by the unprofessional behavior of my surgical doctor, i was injured because either the device malfunctioned or the doctor made mistake during the procedure. Thus, this is a reportable event.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125943
Lasik eye surgery resulting in partial blindness in right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1125983
In 2003, i had lasik surgery. Since that time, i have experienced extreme dry eyes and eye pain. On many days i cannot see much at all. I have had medical treatment for the dry eyes and pain with minimal success; the eyes will feel somewhat better for a short time only to become near debilitating again. Dates of use: #1. 2003, #2. 2004. Diagnosis or reason for use: #1. To improve vision. #2. I don't actually remember why they "enhanced" by eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1120483
Prior to the lasik procedure, a treatment table from the wavescan 3. 9 software was generated that resulted in an induced astigmatism of 3. 2 diopter in the right eye and 1. 2 diopter in the left eye. In addition, the right eye received an over correction of 2 diopters. Pt's uncorrected visual acuity is 20/40 in the right eye and 20/30 in the left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1111792
Received lasik laser surgery on my eye. Since that time, my eyesight has deteriorated terribly and i have permanent blurred and foggy vision. Diagnosis or reason for use: to improve eyesight.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1108803
I underwent custom vue lasik procedure in 2005. After the surgery, i have experienced the following problems in my left eye: approximately 1-2 months after the procedure, my tear ducts left eye completely closed and my left eye is constantly tearing. I have undergone surgery to try to open up the tear ducts, but the surgery was unsuccessful. Over the past 2 years, my vision left eye has been getting progressively worse and i have been diagnosed with ectasia -thinning/warping of the cornea-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119026
A voluntary medwatch was received from the fda. Info indicates a pt experienced difficulties following bilateral lasik surgery. The report is for the left eye, the right eye is being submitted under mfr report # 1061857-2008-00169. This pt reports experiencing blurry vision, halos, starbursts and dry eyes 4 months following initial lasik surgery. The following year an enhancement was performed on the left eye to address residual myopia and regression. One year later, a second enhancement was performed on the left eye, this is to correct residual myopia and astigmatism. This pt stated these surgeries resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts and loss of contrast.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1119083
A voluntary medwatch was received from the fda. Info indicates a pt experienced difficulties, following bilateral lasik surgery. This report is for the right eye, the left eye is being submitted under mfr report #1061857-2008-00170. This pt reports experiencing blurry vision, halos, starbursts and dry eyes 4 months following initial lasik surgery. The following year an enhancement was performed on the right eye to address residual myopia and regression. Eight months later, a second enhancement was performed on the right eye, this is to correct residual myopia and astigmatism. This pt stated these surgeries resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts and loss of contrast.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104239
An optometrist reports a hyperopic pt that is unhappy following bilateral lasik surgery. This report is for the left eye. The right eye is being reported under mfr report number 3003288808-2008-00008. The pt was a +5. 00 diopter pre-op and at 1 month post-op was +1. 75 diopter which regressed to +3. 00 diopter at the 7. 25 month post-op exam. Bcva remained the same as pre-op (20/20) and ucva improved from 20/200 to 20/100-. The pt reported difficulty driving at night due to glare and 'can't see as well as before the lasik'. This pt has a history of esotropia, and during the post-op period, the pt reported the left eye was 'turning in'. Additional info from the optometrist indicates this pt had strabismus and was likely an amblyope. The optometrist also stated the pt was becoming more presbyopic which was causing the pt additional frustration.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1104240
An optometrist reports a hyperopic pt with a poor clinical outcome following bilateral lasik surgery on the right eye. This report is for the right eye, the left eye is being submitted under mfr's report number 3003288808-2008-00011. A 6 months post-op, this pt exhibited a 1 line decrease in the right eye and ucva went from 20/50 pre-op to 20/200 post-op. Additional info has been requested.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1103503
I had wavefront lasik surgery in 2004. I was severely overcorrected and had to have a second surgery 4 months later in early 2005. I have had severe dry eye ever since. I use drops almost every hour -systane nonpreservative vials- and get up at night 2 to 3 times to put drops in and still wake up with red, irritated eyes. My upper eyelids are always swollen and i get irritated eyes if i put makeup or moisturizer to close to my eyes. I have a lot of discomfort and get stabbing eye pain with headaches 2 to 3 times a month. It take two days of advil to stop the pain. I believe i am also uncorrectable. My optometrist hasn't specifically told me this but there is no change to my vision with different lens. I have to wear reading glasses to see within arms length now and didn't right before the surgery but needed to right after the surgery. I had to wear my husband's reading glasses to see at all until the next surgery. I was unable to read or write or drive a car for 4 mos.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1082580
A surgeon reports one pt with decreased bcva following lasik surgery. Follow-up with the surgeon indicates the patient's vision has returned to 20/20, the topographies look well centered, the epithelial irregularities have cleared with the use of dry eye medication and punctal plugs. The surgeon also stated the pt has not been harmed or injured. The surgeon did not provide any info regarding this patient's pre-op bcva measurement and has declined to provide any other info regarding this pt, and requested we not contact him any further regarding this matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1088924
Alcon received a voluntary medwatch from the fda. The pt reports following lasik surgery for severe hyperopia and astigmatism, she is experiencing a loss of best corrected visual acuity (she cannot achieve 20/20 in the right eye), halos, starbursts, dry eyes, ghosting and loss of contrast sensitivity. The pt also reports she no longer drives at night because the oncoming headlights obscure the road. In addition, the pt stated she had difficulty holding her eye still during the procedure,although the dr repeatedly instructed her to hold still. The surgery was 5 yrs ago, and the pt still has symptoms.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1089204
Alcon received a voluntary medwatch from the fda. A pt reports chronic problems and disability following lasik surgery. Pt records were received and reviewed. This pt was treated for a monovision outcome, the left eye being treated for distance vision, the right for near vision. During the post-op period, the pt experienced dry eye issues, trouble with depth perception in the left eye, difficulty reading newsprint, halos at night and blurry vision. The surgeon noted early dry macular degeneration approx 5 months post-op, blepharitis throughout the later post-operative period, and noted the blepharitis and dry eye issues were affecting the pt's vision. Following an enhancement on the right eye, the pt reported an improvement to the near vision, but the mid-range was not good. The pt continued to have near vision difficulties throughout the post-op period. At the last post-op exam provided, the pt experienced a decrease in bcva in the right eye from the initial pre-operative measurement.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1080832
Rptr reports that he had laser surgery in 2005 and now he has double and blurring vision and has to use many eyedrops. Reporter states that dr will not see him, or honor the warranty that he has. In oct 2006 rptr states that he had to have plugs inserted for dry eyes and saw a specialist and was told he had a refraction and his eye was the shape of a football. In 2008, pt had "lasik surgery touch up". Rptr states that he had 7 f/u visits and was told that he had scar tissue and an astigmatism and would have to wear an eye patch on his right eye. Pt states that he now has to have glasses to see after paying thousands of dollars for lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081320
A surgeon originally reported a patient with topographically-observed "central islands" (corneal irregularities) following a custom myopia with astigmatism laser procedure. The patient's outcome following the initial procedure was reported under mfr report #1061857-2007-00332. An enhancement procedure was performed on a different laser platform from the initial procedure. This report is for the pt's outcome following that enhancement procedure. At approx 2 months post-enhancement, the pt's bcva is 20/80, a 4 line decrease from pre-enhancement and ucva is 20/400. Notes on the pt's records indicate, "right cornea has +1/2 reticular haze centrally with pericentral tough supero-temporally".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081426
In the midst of my lasik surgery on my right/first eye. The dr announces that "we are dealing with a free cap". After he completes the surgery on the right eye that lasts almost half an hour, he tells me that "there must have been some mismeasurements". We can continue and run the risk of the same thing happening to the left eye or he can make some adjustments and hope we don't have to repeat free cap. At the time i was too traumatized to understand the full meaning of a free cap and knew i would never come back if i left at that moment. Fortunately, the left eye turned out fine. Unfortunately, there were not appropriate markings to replace my free cap in its correct position. During the next 12 months, i had 5 further surgeries to turn, stretch, stitch the free cap in its proper position. In the end, the amputated cap was removed. I now have to wear a hard contact to get any vision in that eye. It's very painful, irritating and stressful. The reason i originally had the procedure was to not wear soft contacts. I cannot get the hard contact out without a plunger and it is always painful.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081413
Lasik enhancement, 2 more subsequent enhancements, irregular astigmatism.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081298
Post operative data of a pt treated with the wavescan revealed an over correction of +2. 00 diopter in the right eye at one month following treatment. Pt's best corrected visual acuity is 20/25-2.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1078776
I had lasik surgery in 2001; a year later, my vision had worsened, so i had to have it again; to this date; i cannot see anything without rigid gas permeable contact lens that i can only wear for 8 hours a day; i'm literally blind without these glasses; i only wish i'd never gotten this surgery, because glasses don't even work. I'm really sad and depressed about this.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1208863
I had surgery in lasik center in 2008, i was farsightedness using 1. 50 glasses i went to have a consultation to see if i was a candidate for surgery, they said i was the perfect candidate and that it will be done in less than 10 minutes. The day of the surgery, a lady doctor who was going to perform the surgery told us that we may need reading glasses after the surgery, she never told us that i won't be able to see up to 8 feet or that i will have this problems that i am writing below. Discomfort of pain, blurry vision, dryness, glare, halos, starbursts around light, itching, scratchiness, light sensitivity, i can hardly see my face now, i cannot perform my job, i have been buying almost 30 pairs of glasses trying to fit one to my needs and my life, it is not the same any more. I am very depressed, grieving, desperate, they have ruined my eyes and my life, and the life of my family. Please help me. I don't know what to do now. I feel blind, i can do nothing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1202339
I received lasik on both eyes in 2006 at the laser eye center. Dr of the eye consultants performed the surgery. I experienced severe dryness after the surgery. I also experienced problem driving at night and watching tv. Some days were good and some were bad. When things started getting really bad, i went back to dr. After some tests, he concluded that my vision distortion is caused by a condition in the cornea, something he termed as 'keratoconus'. He also mentioned that my eyes could be susceptible to eventually suffer this condition, but most likely the progression got elevated by the lasik. He has signed me up to participate in a study called 'collagen cross-linking' of the cornea - at institute - where they use a combination of vitamin b2 and uv light to strengthen the corneal muscle. This study is my only hope. If this does not work out for me, then i would have to consider a corneal eye transplant according to dr. I seriously regret having done lasik. I am hoping that this complaint will help fda to help future potential lasik candidates to seriously consider all options before opting.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1193647
In 1997, i had lasik surgery performed on both eyes. I had an enhancement in 2005, 1998 on my right eye. I now suffer from debilitating starbursts, halos, poor contrast and depth perception, and severely limited low light vision. Where i once was able to drive freely at night, i can no longer get around even on foot. Even in daylight i often mix up my own children with other people's children from distances as short as 6 feet away. I also suffer severe headaches from intense eye strain and the use of pilocarpine drops -. 5%-. Pre-existing conditions were: congenital nystagmus, myopia, astigmatism, night blindness - able to drive at night. My pre-operative readings were: measurement od os ou vcc 20/20020/40020/200 bscva 20/40 - 20/50, 20/10020/40 - 20/50. Refraction. -10. 00, -5. 75 x 010, 20/80, -10. 50, -6. 00 x 155. 20/200, 20/75. My current visual acuity is around 20/60 - 20/70 ou. Although i visited dr's office numerous times to seek help with the symptoms mentioned above, i was always told that everything was perfect and that these "side effects" were temporary and would go away, which they never did. In 2001, i finally gave up on dr and saw another lasik practitioner who informed me that i had decentered ablations, due to my nystagmus and that i was contraindicated for lasik at that time. I later learned that i also had significant higher order aberrations and was also contraindicated, due to the degree of my myopia and my pupil size.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1190204
Ectasia in both eyes due to lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1187773
Ophthalmologist performed lasik surgery too soon after stopping wearing rgp contact lenses. He said my eyes were stable only 3 weeks after giving up these rgp lenses. They were not. As a result, my eyes continued to change drastically for several months after the procedure. I went from being myopic, about 8. 00 diopters to hyperopic. He also left me with very significant striae in my cornea, especially the left one. He tried to "iron out the wrinkle" the next morning. The visual lack of acuity continued for a long time and he would not tell me what was wrong with my vision. I finally was compelled to go to another ophthalmologist in the area, who said a special procedure had to be done immediately to try to get the striae out. I then had to go under this procedure which was not covered by insurance. This helped to a large extent. I could not, however, get a refraction for glasses or contacts for about 4 yrs that would correct my vision. I now have to wear rgp lenses once again. Eyeglasses cannot be prescribed as they will not work. Therefore, i can't correct my vision - for example when my eyes are inflamed or irritated- unless i'm wearing them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1183965
I had lasik surgery 4 yrs ago. I have been suffering from chronic dry eye since. When i first returned to the surgeon who performed the lasik surgery, he informed me that my surgical incision had healed beautifully, and that he did not have an answer as to the constant red eyes. After two yrs, and 200 bottles of visine later, i finally went to another dr who informed me that i had been suffering as a result of the lasik surgery. We gave our college aged son the lasik surgery as a birthday gift the same year!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1177611
Not sure of exact dates, but had lasik done about 18 months ago. I now have severe, irrepairable dry eye syndrome. The pain is debilitating, intense, and continual. I have been advised by dry eye specialists that the condition is permanent. How will i live when i get too old to apply the eye drops i have to use literally every 5 minutes? the worst is the massive and intentional lying regarding risks. The sales person told me that they had only ever had two individuals suffer significant issues post op. The surgeon himself misrepresented the risk. Dr. Himself told me verbally that the only instance of permanent injury was when a lady accidentally poked herself in the eye with a garden tool and peeled the flap back. He specifically told me the risks of severe side effects were ''very remote". I suppose dry eye syndrome is considered a "minor" complication. I should have noticed earlier that dr. Himself has yet to discard his spectacles. This quack of a money whoring surgeon should be censured at least, and preferably shot between the eyes for intentionally lying to me regarding the statistical risk profile of this procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1232234
There is epithelial ingrowth in both eyes and i can not see clearly near or distant both. Refraction test shows cylindrical, as well as spherical number in both eyes. All my jobs are suspended since the operation i. E. For the last 2 mos. Overall, the irregularities in the corneal surface is suspected to be responsible for all the existing problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1230095
Approx 6 weeks after lasik surgery, i noticed that points of light at night are doubled -e. G. , instead of one red traffic light, i see two-. Surprisingly, i don't notice much of the haloing and starbursting that are usually described as lasik night vision problems. I have also noticed that i experience double vision in my right eye during the day time. This is most noticeable when trying to read a ruler or tape measure. All the graduation lines are doubled and i have to close my right eye to determine the correct measurement. I have also noticed a dramatic increase in the number and density of the vitreous opacitities -floaters- in my vision. This increase also occurred at approx 6 weeks post surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1226129
VISX Laser: Severe contrast, low light issues from lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1224224
Lasik surgery- non wavefront- roanoke, va at eye care & surgery. Adverse event- g. A. S. H. - glare- arc of light- starbursts- halos- at nighttime & in low light settings.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1216517
Dr. Performed my lasik in 2007. After the procedure, i developed chronic dry eye. I hadn't had this problem before the procedure and was not warned about it prior to the procedure. I went back to dr. Norden and he inserted plugs in my tear ducts and explained that women over 40 tend to have this problem. I would liked to have been warned beforehand so i could have made a more informed decision about this procedure. Now, over a year later, i still have plugs in my tear ducts and wake up in the middle of the night with difficulty opening my eyes and have to put drops in to be able to sleep. My eyes are sore, very dry, and puffy in the morning and i'm concerned about the long-term effects. I have been given a prescription for restasis but am afraid of forming a dependency. I thought that after all these years this procedure had been perfected and i knew all of it's shortcomings, and i'm very disappointed with the results. With all the problems, i would at least have hoped that i would have come out of it with perfect vision, but that was not the case. Dr. Offered to do the procedure again to fix my vision, but i'm afraid my eyes will just turn to dust if i take him up to it.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1215203
I had lasik eye surgery from dr. In 2006. It was the biggest mistake of my life. Here is a list of my concerns: - my last checkup occurred last year, and i still remained at 20/15 on my right eye and 20/20 on my left eye. This is very misleading as things over 20 feet are blurry. They're especially blurry in medium to low lighting. I had no idea that my eyesight was definitely going to be worse afterwards. I thought since 20/20 was very likely, my vision could remain perfect at far from it. My vision also fluctuates depending on how much rest i get. I believe it's because the more i rested i am, the bigger my pupils are. Bigger pupils lead to seeing more through untreated parts. -they only treated my eyes partially and did not warn me of this. The treatment zone simply did not cover my entire eye. I have big pupils. The cut did not go outside of my pupils but within it. The outer area of my pupils remains untreated. I was not warned of this. I just cannot understand how they can get away with something like this as it has severely affected my vision for the worse. -i was not warned that i was going to get a permanent scar on my eyes. I believe it plays a big part of my blurred vision. -i was not warned that my night vision was definitelly going to get worse. I was very shocked the next day to see that my night vision definitely got worse. This should not be a surprise. I was simply warned about the possibility of getting starbursts and halos. I have a severe case of both. Based on the size of my pupils, they should have told me that the likelihood was high. -dry eyes are a constant problem for me. I've experienced loss of sleep and lack of sleep, due to extreme dryness that wakes me up or severe crust formations that did not exist before surgery. I was not aware that there are tests to determine how dry your eyes are. This should be a mandatory test. I have to put several eye drops a day- probably for the rest of my life. This is very costly, embarrassing, and bothersome. - i had red eye for about one month on my left eye. I had no idea that this could happen. It was very embarrassing to have it when i wanted to prove to co-workers and friends that lasik was safe and recommendable, but was i simply showing them proof that i made a mistake. The reputation of my judgement has probably been significantly damaged. -it takes a long time focusing on different distances. If i'm reading something and look up to something, it takes seconds to focus on it. This was always instant before. I was not warned of this. -the stats provided by the media and the ads are absurd. My surgeon asked me if i was glad to have done the surgery the day after. I said i was. He may have put that on record. No one's asked my how i'm doing now. Based on my own personal survey of people having done the surgery, most have regrets.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1213589
I had lasik in both eyes in 2008. I had high prescription of contacts at a -8. 50 in left eye and -9. 50 in right eye. Very high prescrip. My surgeon, dr diagnosed me with dry eye before i had surgery when he was doing some tests. I shouldn't have had this surgery. After surgery, i saw like a freak immediately, though mostly clear, my world has turned upside down. My floor is crooked, my walls are stretched, circles aren't round anymore, my eyes were changing constantly being even one whole diopter different, i was overcorrected, and eventually when i got stern enough, he finally told me i had both decentered eyes. A nightmare i still live with everyday. What was not told to me until i gathered enough information from 15 docs or so, -most of whom would not tell me, only found out because i insisted on my records, that is, if they chose to put what it really was, i found some do not even write what they should on the charts- i found out i had epithelial ingrowth, blepharitis, corneal haze, corneal swelling, post-op astigmatism that the laser gave me!, irregular flaps, and some more i probably don't remember right now. One month after surgery, after my lying doc said all i had was overcorrection, -i knew he had to be lying- i went for a second opinion at laser center and saw another dr od, who worked for dr(third)- he told me i was fine, i just saw freaky because i had such a high prescription and it would take a long time to heal -more lies- then said i too had corneal swelling- of which at that time i didn't know you have to treat with steroids. He did not treat me, told me to see my surgeon in the next week and sent me on my way. Well, because he didn't treat me, and i got to my surgeon too late, i now live with unbearable permanent damage from the corneal swelling seeing a ghosty line around everyone and everything and have no 3dimensional vision all due to him not treating me- i had an episode on the following month, where everything i saw had changed. Mind you, on top of the freak world i "already" lived in with moving, crooked walls, distortion, crooked floor, etc. -and you know what dr(second) saw in my charts that i had dlk-therefore i even had pred forte on my counter and could have taken it till i got to my surgeon if "he" didn't "want" to treat me, and i wouldn't be living like this, had he told me what was going on and how i could fix it or event that i should see my surgeon asap today!, if he wasn't going to help! good thing i have one honest doctor i can now turn to. But the damage is done and not repairable, and believe me if you had to live like this, you wouldn't want to. It's god awful existing this way and being "forced" to see things so wrong. After thousands of dollars spent, i have contacts that help some, but guess what i will never see normal again. Well, i guess i must add, that i do have severe dry eye, of course halos and starbursts, and of course, loss of contrast in a big way. I also have corneal thinning, because i also have only 219 microns left in my left eye and not much more in my right. I fear ectasia, cataracts, corneal transplants if corneal swelling continues, which i've already had again this year! lucky i know now, to go in right away and my new doc "does" treat me. I miss my beautiful world. Can't seven see my own face straight; even with contacts. My nose moves because it is a different shape in one eye than the other, as well as all things being different shape, too. I went in thinking i'd have a miracle, and ended up hating life, trusting none, but one doctor, and having my life turned upside down and never being able to get past it, because it's always "in front of me"! imagine! could you endure? going through a day in life, is no fun and very scare, every day! you know what, even the words on this screen typing to you, do not go straight across, dipped in the middle, up on one end, down on the other and swerved. Can you even fathom living like this? the machine used on me, was an alcon ladarvision 4000, and if i went to a second opinion doc, and i wouldn't let them known who my surgeon was, they'd just ask what was the machine used. I bet it's a faulty machine on top of finding out the doctor has a bad reputation. I've also learned of people who went to well world renowned docs and still had irreversible damage. I just don't think lasik should be done, period! i was responsible for deciding on this surgery, but the truth is, i trusted the doctors know what they are doing and would never do a surgery that would harm, if they knew it did, and i found out the worse, which is they do know it harms! included with that is all the hype that's it's virtually a piece of cake, and foolproof, to find out later the ruth is so many are harmed, -i've met those with transplants, now and who are blinded- and none of us should have to live like this. I had a great future ahead. Had, is how i feel. L:ife will never be the same! thanks for listening.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1212026
Complaint description: my optometrist of 20 years, dr at vision center recommended another dr to do my lasik surgery on my eyes. When i asked which office he was at, dr(first) told me that he was out of the office. I had eye surgery in 2008 at the office with dr(second). Immediately that night, i experienced problems. When i tried to call vision center, we only got a recording. There was no emergency number listed on the space for phone numbers on the papers that they sent home. When i paged dr(first) there was no response. At 1am on the next day, a friend drove me to the er. They too tried to page dr(first) and tried to call dr(second) and vision one. All the doctors could do for me at the er was to prescribe a pain pill and sedative, -which should have been prescribed by second dr to begin with-. The er visit cost almost $500. I continued to have problems and went to see dr(first) my optometrist. He really didn't know what to do because he is not a surgeon. He said i should just keep putting drops in my eyes and it would get better. When dr(first) took the contact bandages off, my right eye got worse immediately. I called up dr(first) and he said that i needed to give it time and it would get better. My eye was too painful to be able to see and i was not able to work. After a week and a half i returned to dr(first) and by that time i had serious issues with my right eye. After talking to second dr by phone, i was referred to an eye surgeon, another dr. I went to dr(third) and he had to perform surgery to lift the flap on my right eye and clean underneath it due to growths around and under the flap. My eye was very painful all over again, and i was not able to see clearly or work. I continued to see him a few times a week for several weeks. It was at that time i learned dr(second) does not live in town. He lives in another state. That is the reason why he could not see my when i developed problems. If i had known that he does not live here, i never would have used him as my lasik surgeon. Now after several mos of going out for appointments with third dr, i still can not see out of my right eye. It is like looking out of a blurry dirty film. It can not be corrected with lenses or glasses. I have to have another surgery on nov. 6 and dr(third) says i will need another in 4-6 mos. So far i have been billed for thousands of dollars and that does not include prescriptions or patches that i had to buy. That does not include the surgery on approx five months later, or any future visits to dr. Foulkes. I have had to miss weeks of work due to pain and loss of vision. I have had to take off work to drive out to hinsdale to see dr(third) many times. Lasik surgery performed by second dr on original date. Follow up care by dr(third) to try to correct problems. On ten days later, corrective procedure performed by dr(third) to lift flap of right eye to clean underneath. On the next day, follow up care dr(third), two days later follow up care dr(third), three days later follow up care dr(third), the following month(two days later) follow up care same dr, five days later follow up care same dr, three days later follow up care same dr, a week later follow up care same dr, the following month follow up care dr, eighteen days later follow up eye surgery to clean under flap in right eye by dr, three days later follow up care same dr.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039137
I had lasik surgery to correct my vision. I now suffer from extreme severe dry eyes. I use drops every 1-4 minutes in each eye. The surgeon still has me using the sterile drops and has me taking various supplements. He has also permanently plugged my tear ducts. Our monthly bills for drops and supplements! i am also in constant pain. I cannot drive at night or see well at dark. My day activities have been altered drastically. I cannot do so many activities due to eye pain, and needing to stop and use drops every 1-4 minutes. My vision is fuzzy at all times, except for about 5 seconds after administering the drops. I cannot read road signs or see faces. Of course i fear the worst, which is blindness. Because of pain and extreme light sensitivity i have to always wear dark glasses. As far as i can tell from my records, i was never asked or tested for dry eyes prior to the surgery. I thought i was suffering alone until the recent reports have been highlighted. My husband, parents, and relatives are chiropractors. They have me on the best supplements for dry eye, but nothing has helped much. If you know of anything else out there, i would be most thankful for your advice. Respectfully. I don't know the name of the machine used, but the date was 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039138
I flew to have perform lasik on both eyes. Since, today's date is 2008 and going on 9 years, my vision has been distorted, i have dry eye syndrome, decentered flaps cut from the microkeratome blade, and an uneven laser reshapement, permanently thinning out my only corneas further ruining my vision for life. I have spent, trying to return my vision to normal with no luck. I have traveled around the world and have seen the best doctors, all with no fix in line. My own dr, has lawsuits and has continued to lie to myself and my family about the lasik procedure going wrong, very wrong, horrifically wrong. I want a complete investigation of my dr's lawsuits, his lies, and his unprofessional ways. He has harassed my family, attempted to sue us to the tune -he failed- because of my website that warns the masses about lasik and lasik doctors like him. I want justice. Lasik will never be safe because it is still unpredictable surgery. One person it works for, and the next go blind or have complications beyond control to deal with. At least with contacts or glasses, you can get by with sane vision. The consent form is a joke at best. It does not give the consumer all of the known and unk symptoms, side effects, and long -term problems that it should be giving them. It protects doctor while injuring the pt. Complaint and investigation on: the vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039140
In 1992, i lost my vision after refractive surgery - rk. In early october i had gone to a "free" seminar to gather info before i saw a dr. I had pre-existing scar tissue on my left eye but dr said "no problem", and we proceeded with bilateral refractive surgery. I did not have good vision from the start. I was told that "things have not settled down yet. We can always perform an enhancement. " i struggled with my duties at home and work. In 1993, i went to another city to see another dr -a referral from dr(first)-. He performed a prk on my left eye with later plans to surgically improve the right eye. At that time second dr told me that dr(first) made the cuts in my eyes too deep and too long. My left eye now had vision worse than pre-prk and was covered with scar tissue from the laser. In 1995, i went on medical leave from my surgical nursing position and had a corneal transplant. During that year, i filed for disability retirement. In 1996, i went to jury trial -case, medical malpractice. I was the victim made to look like a perpetrator. We lost the case and threw ourselves into debt. Dr(first) told me i was a good candidate for refractive surgery, that i would have good results and could throw away my glasses. He never told me there was no turning back from this surgery. He never mentioned the star burst, night blindness, double vision or painful dry eye. He never mentioned that i would not be able to care for my three children. I live the nightmare every day and cringe when i see the same advertising today as when i had my disastrous eye surgery. Dates of use: 1992 - 1993. Diagnosis or reason for use: rk cutting device and laser for prk procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039141
Event: bilateral lasik refractive surgery to correct nearsightedness. Outcome: initially corrected to 20/25; about 3 months after surgery, regression began, causing nearsightedness to return and requiring use of expensive custom contact lenses to achieve 20/20 vision. Night vision severly damaged: corneal surfaces healed with a non-smooth surface, causing severe higher order aberrations -hoas-, which cause visual disturbances, including: large starbursts when looking toward any light source, such as car headlights. Multiple -more than 20- images of bright objects. Much poorer ability to discriminate objects in dark or dim rooms. Night vision disturbances and hoas cannot be corrected with glasses, or with most types of contact lenses. Require expensive custom-made large diameter rigid gas permeable -rgp- contact lenses. Annual expense for rgp lenses and special cleaning solutions: for first pair of lenses -including professional fees- with duplicate lenses for each lens. Annual cost of cleaning solutions and devices; dry eye caused by lasik causes discomfort when using corrective contact lenses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047150
My lasik experience: after initial surgery in 1998, then enhancement in 1999, my vision in both eyes, uncorrected was 20/20. This was truly a miracle for those of us so dependent upon contacts and glasses. I remember disposing of all my old contact lenses and extra cases. No more lens cleaning, scrambling for glasses at night, occasional discomfort etc. This visual quality of life lasted 9 months. Then, gradually the sight in my right eye deteriorated to 20/100 by late 1999. I also noticed declining vision in my left eye, just to a lesser degree. My lasik process from the outset was being handled by both my local od and surgeons from the nearby medical school clinic. Neither could understand this change but both concluded that in early 2000, i should undergo a 2nd enhancement on both eyes. The outcome of this 2nd enhancement made no improvement and further thinned my cornea to less than 250m r and 275m l. Eventually, ectasia or keratectasia became the diagnosis and rgp lenses were prescribed. My average best corrected post lasik vision with a rose k rgp in the left eye is 20/25 and a boston scleral lens in the r is 20/40. Typically, i am able to wear my lenses with reasonable comfort up to 15 hours daily. Unsuccessful results: unsuccessful results as in my situation, tend to lead to various complications such as ectasia or keratectasia, dry eye problems, depth perception difficulties, and in general, intense disappointment. Most likely, the real reason for unsuccessful outcomes in the pre lasik screening and preparation process was not adequate and the surgeon was too aggressive in the degree of correction. Also, as is the case in all vocations, there are some physicians who are simply not qualified. Another contributing factor to complications after lasik surgery can occasionally be the result of obsolete or faulty calibrated equipment. Lastly, is the fact that fundamental mistakes are made even by the most qualified doctors. I believe and again emphasize that if attentive pre lasik screening is adhered to, reasonable margins for error are considered, and detailed checks and balances are built into the lasik process from beginning to end, complications as a result of lasik surgery can be significantly mitigated. When you get to the stage many of us are in, anger, frustration, and major disappointment is natural. We ask; why did this happen? what should i do? what will be the final result, i. E. Will i end up blind? although still very difficult, i try to objectively negate or offset many of these disappointments and concerns by concentrating first by simply coping but secondly and most importantly, focusing on the prospects that better treatments for ectasia, kerataectasis, and keratoconus are being constantly developed and in the not too distant future, a long-term viable solution will emerge. Detailed history: 1998: preop exam, manifest r -7. 00-1. 75x030 20/20. L -6. 75-2. 25x162 20/20. On the following month: two week status post lasik. Visual acuity without correction 20/25 r and l. Manifest r -0. 50 sphere 20/20. L -0. 75 sphere 20/20. In 1999: three months status post lasik. Visual acuity with out correction 20/20 in the right eye, 20/25 on the left eye. Manifest r -1. 00 sphere 20/20. L -0. 25-0. 75x130 20/20. On approx three months later: six months post lasik. Visual acuity with out correction 20/50 in the right eye, 20/25 on the left. Manifest r -1. 00-0. 25x010, l -0. 25-0. 75x140; 20/20 vision in both eyes. On approx six months later: visual acuity with out correction r 20/60, l 20/40. Manifest r -1. 00 sphere. L -0. 75-1. 00x145, 20/20 acuity in each eye. In 2000: 24 hr post lasik enhancement. Visual acuity with out correction 20/20 in the right eye, 20/20-1 in the left eye. Manifest r plano-0. 50x050 and 20/20 vision l -0. 25 sphere 20/20. Two wks post lasik enhancement. Visual acuity 20/20- right and left eye. Manifest r plano-0. 50x055, l-0. 50 sphere 20/20 vision in both eyes. In 2000: three months post lasik enhancement. Visual acuity without correction 20/25 in the right eye, 20/20 in the left eye. Manifest r plano-0. 75x055 20/20 vision and l plano-0. 50x140 20/20 vision. On approx three months later: six months post lasik enhancement. Visual acuity without correction 20/30 in the right eye and 20/25 in the left eye. Manifest r -0. 25-1. 00x065 and l -0. 25-0. 50x130 20/20 vision in both eyes. In 2001: one yr post lasik enhancement. Visual acuity without correction 20/100 in the right eye and 20/50 in the left. Manifest r plano-3. 50x086 and l-0. 25-0. 50x130 with 20/20 vision in both eyes. On the following month: preop for lasik enhancement #2. Visual acuity without correction 20/100 in the right eye and 20/32 in the left. Manifest r was -0. 50-3. 25x081 and l -0. 25-0. 50x 130 for 20/20-3 in the right eye and 20/20 in the left. On approx seven months later: visual acuity without correction was 20/100 in the right eye and 20/32 in the left. Manifest r -0. 25-4. 25x094 for 20/25 acuity and l -0. 50-0. 75x115 for 20/20. On sixteen days later: lasik enhancement #2. On the following month: two weeks post lasik enhancement #2. Visual acuity without correction. Was 20/50 in the right eye and 20/25 in the left. Manifest r plano -0. 75 x 040 with a variable response for best corrected visual acuity of 20/50 and l plano -0. 75x135 for 20/20. On approx three months later: three months post lasik enhancement #2. Visual acuity without correction was 20/50 in the right eye and 20/25 in the left. Manifest r -0. 50x1. 00x060 for 20/40 acuity and l pano-0. 75x 135 for 20/25 visual acuity. Since the enhancement #2, continuous central pek worse in the right eye than the left. In 2002: five months post lasik enhancement #2. Visual acuity without correction was 20/100 in the right eye and 20/30 in the left. Manifest r -0. 75- 2. 75x35 for 20/20 visual acuity. Irregular steepening in the central cornea, mild pek, confirmed central comea ectasia. On the following month: contact lens fit od that achieved 20/25 vision. One and a half months later: change in visual acuity in the left eye. Manifest refraction l plano 1. 75x 50. On four weeks later: initiated rgp fitting of the left eye with visual acuity of 20/20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039109
I had lasik surgery performed in 2005. A year's long problem with dry eye syndrome, itching of the eyes, there were days i came home from work and wanted to rip my eyes out, they itched so bad. Had lots of blurred vision, was put on restatsis for 6-9 months. The hospital where i work -i'm a veteran- put permanent plugs in both bottom tear ducts to help with dry eyes, but this created a lot of fluid build-up at night to where my vision was even blurrier. My provider who performed the surgery eventually told me to blow dry my eyes every morning. What a joke, i paid him 4,000. 00 to have all these problems. If i had this to do over again, i would never have had this procedure performed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039110
Lasik surgery that has resulted in ghosted vision, reduced night vision, halos, reduced vision in dim light, and loss of contrast in dim light. Diagnosis or reason for use: nearsighted -4. 25, no longer able to tolerate contacts, glasses cause.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039111
Had a lasik procedure completed that resulted in reduced vision in my left eye and improved vision in my right eye. In the process of creating the corneal flap, the entire cornea came loose and had to be stabilized with a contact after the procedure. The complication was labeled normal, and my claims of blurred vision and poor outcome were not taken seriously by the facility that completed the procedure. However, i am a nurse and had a chance to speak with an ophthalmologist regarding the procedure. The ophthalmologist attributed the poor outcome entirely to the error of the unsuccessful flap creation in the left eye for the laser. Lasik surgery in 2007 laser.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039112
I had lasik surgery in 2006, and have suffered significant eye health issues ever since. While my eyesight is good, i developed superior limbic keratoconjunctivitis -slk- and severe dry eye syndrome. According to webmd, "it is believed that slk is present secondary to superior bulbar conjunctiva laxity, which induces inflammatory changes from mechanical soft tissue microtrauma. " ophthalmologists treated the slk with drops and environmental modifications for a full year with no success. I have since reluctantly had additional surgery - conjunctiva resection on both eyes, but am still experiencing problems. My ophthalmologists say they cannot begin to treat the dry eye syndrome until the slk is brought under control. Unfortunately, the lack of an adequate tear film aggravates the slk. I believe this vicious circle was directly caused by lasik surgery. Neither the surgeon nor the surgical center where i rec'd the lasik adequately warned me of the dangers. Although it was not bothering me at the time, they measured my tear production, determined i had dry eyes prior to surgery and started a course of restasis. Knowing what i do now, that alone should have disqualified me from the procedure. I urge the fda to mandate stronger criteria to disqualify people for this procedure and to promote additional pt education prior to surgery. Dose or amount: bilateral surgery, frequency: once.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039113
I received lasik eye surgery two years ago. Since that time, i have had three "touch-ups" due to poor results. These poor results include: - blurred vision - dry, itchy eyes - a feeling that something is "in there" - extreme sensitivity to light - fear of night driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039114
After effect: night halos, especially while driving; dry eye; noticeable weakening of correction within 18 months of procedure. Glasses required for night driving. Pre-procedure: despite requests, i was never able to speak directly with the operative surgeon until moments before the procedure and then, only just briefly. There was no substantive contact with the surgeon, ever, even post surgery. Also, pre-procedure, i was shuffled between two optometrists in the office and had trouble getting consistent info about the details of my correction. It felt like a mill; i was just one of the masses. P. S. Despite the problems, i feel that lasik requires a risk-benefit assessment for each pt. I suffer these after effects, but if i had the option to choose the procedure again, i would probably do it. The benefits outweigh the after effects. For others this may not be true. It is an assessment that each individual must make. If i could do anything differently, it would be to interview more facilities/physicians, instead of just going with the one who i thought had the best record. I should say, also, that i chose mono-vision so that one eye sees far away and the other sees close. I do not need glasses for reading or distance, only for driving at night due to halos. I do have some trouble with intermediate distances, say three to four feet.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039121
Lasik surgery flap not sufficient to proceed in left eye, device did not fit eyelid. Redid surgery in several months, 2006, using another technique. Painful dry eye resulted immediately in both eyes from original lasik surgery and has not remitted fully, although, improved with daily use of expensive eye drops - cyclosporin.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039122
I was overcorrected in my left eye as a result of wavefront prk with the visx excimer laser. Not only that i have, terrible side effects in both eyes -gash- which greatly affect my night vision and vision in low light situations. Mild dry eye is also problematic. For a procedure that was supposed to make my life easier, it has made it much more difficult and complex on a daily basis. I so very wish that i could go back to my vision with glasses. Not a day goes by that i am not reminded of the adverse events following my prk. Date of use: 2006.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038013
Laser vision correction surgery. An inexperienced surgeon or defective machine cut flap too deep leaving a bulge on my eye. Second surgery in 2005 -by the same surgeon- to remove bulge, damages the cornea and leaves me with the uncurable eye disease pinguecula. The surgeon contends i have dry eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038108
Dear sir/madam: please be informed that i had a lasik surgery in late 1996 at the hospital by a dr. I have written you a certified letter on 04/28/2008 in reference to the problem, and i have also written certified letters through the years to medical entities, and political officers. Dr did a malicious act by masking half of my cornea and created fluids under the cornea flap to conceal the immediate results. I have been all over the world to see if something can be done to correct my cornea, but nothing can be done. In my letter to you, i have enclosed tomographies, so you can see that only a human hand could have covered half of the cornea and create fluids under the flap. Currently, my cornea is irritated, i can't wear contact lenses, and i can see triple images. I hope your agency shall investigate this matter and bring dr. Mcdonald and other doctors like her to justice. If doctors like dr are left unchecked, the problems doctors injuring patients will not go away, and we will have an injured handicapped and unhealthy society. Sincerely.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038117
Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference from l to r eye. Left eye also still has bad astigmatism, had to get prescription reading glasses for one eye to slow down headaches. I paid the extra per eye, for lifetime touch up. After waiting 1 yr, i went back to see if they could balance out the eye better and was told no. Unless they get worse than 20/40 they would not do it. That was not told to me at the time of surgery. Why pay the extra money then? i am now very light sensitive. As my md told me, photo-phobic. The need for sunglasses is all the time and i have even had a few episodes that were so severe that i had to pull over when driving. It is interfering with my work. Floaters or what i would term as dirt floating around in the eyes, which is really loose blood vessels. I was told that these would go away after a few weeks as they started shortly after the surgery. It's been a year and a half and there's still a lot of them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038120
After lasix surg: i had preexisting ectasia which went undiagnosed by the dr. He took 2 thermal photos on two separate appointments that now we know clearly show red, thin areas of the cornea. After the first surgery, i could not see as well as before surgery and dr kept saying it will get better. Never did. He did what he called "an enhancement" which he said would re-center my vision, removing even more tissue. He was going to do a third procedure "enhancement" and was stopped by the head of the eye dept at the out of town hosp where the surgery was done. I see halos, star bursts and now have to wear contacts to hold the cornea down. Dry eyes is a huge problem. Night driving is pretty much not possible except in emergency. Long drives to parents and friends is not something i can do anymore. Lost 30 peripheral vision as well. Just about ruined my life and dr never said, i'm sorry. No help at all.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038128
I had lasik surgery two years ago. Mostly it has been perfect, but my night vision is awful now. It used to be very good. It's almost scary to drive at night. Especially when it's raining. I never had that problem before. It's like when the sun shines just right into a camera and the light spreads and blocks stuff out. Also i see the halos around duller lights. My vision during the day is fantastic.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038131
Lasik surgery. I was not a good candidate having a size 7 pupil and -10 1/2 refraction with astigmatism. My night vision is impaired and have to stop driving at night. Have starbursts and very dry eyes which affects vision. Had extreme pain after surgery and 4 months of very little vision. Ten years later i have macular degeneration in one eye which has further debilitated my sight. The surgeon said i was an excellent candidate which was clearly not the case.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038099
Following lasik surgery, i have had problems with serious dry eyes. Every morning i must use eye drops and most nights as well. In addition, in the dark light objects have sunbursts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038103
I was talked into having rk-radial keratotomy- on my eyes by dr. He said, he never had a problem with any of his surgeries and guaranteed me a successful outcome. After the surgery, however, my eyes became very fatigued and sore. He said that i was reading from the twenty-twenty line on the eye chart and that this problem is in my head. He offered no support or guidance in this matter whatsoever, and practically dismissed me. I was shocked. Now i was left with sore, tired, fatigued eyes and no answers, since this was a new procedure in our area. So i began a journey to try and find a solution. This journey has taken me to numerous prominent eye surgeons. The have prescribed soft and hard contact lenses, glasses, performed ck-conductive keratoplasty-, lasik twice, and nothing has really corrected the problem. The pitfalls of corrective eye surgery need to be honestly discussed by these eye doctors, not covered up by misleading advertising and hype. Thank you for your time and concern in this matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038104
Lasik surgery. Extreme pain in eyes lasting 2 weeks. Had to stay in darkened room for a month. Since operation every thing is dim. Very difficult to drive at night, halo and sparkler effect from lights, extreme dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038106
Lasik surgery was performed with less than desired results. The patient requested clear distance vision and the results were clear close-up vision with maintained distance vision requiring corrective lenses. Lasik was performed again on the left eye with better results, but still less than desired. In 2007, cataract surgery was performed on both eyes to obtain desired results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036129
Was supposed to have lasik surgery, but had prk because the md said i did not have enough cornea. Prk in early 2008. That night the bandaid lens fell out of my left eye and formed a corneal abrasion. After many visits back to the md, and he stating everything looked good for about a month. I visited another md because my eye looked like it was going to fall out of the socket. The 2nd md stated i had a terrible infection behind the cornea. He treated me aggressively for about 2 weeks. No improvement with many eye drops and daily visits to the md. The md stated that he had to do an emergency corneal transplant or i might loose my eye. I have a permanent disability 20/70 in my left eye. I continue to have discomfort and i am recovering from shingles of the eye. My outcome for vision is not good. I had 2 other md visits and they both agreed regular lasik surgery was much better, and i had enough cornea flap. I feel that the first md from lasik plus in tampa fl neglected my care and eye. He never addressed an infection. I was put on large dosages of pain killers and tranquilizers and sleeping pills for the pain. Each time i would visit the md, he would say 2 more weeks and you will be healed. If i would have not gone to another md, i would have lost my eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037947
Laser: VISX S4
In 2007, i underwent lasik vision correction surgery. I was screened and declared a perfect candidate for the surgery. The surgery itself went exactly as planned with no "surgical" complications. According to the dr, the healing process also went normal and i was declared to have an excellent outcome due to my low refractive error. However, in spite of this, the results of this surgery were actually disastrous. Although my post-surgical refractive error is quite low, the surgery induced a significant level of higher order aberrations, including a highly abnormal level of spherical aberration and coma due to a correction zone that is much smaller than my scotopic pupil size. I see fine in direct sunlight and natural lighting, but have difficulty seeing clearly under normal levels of indoor or artificial lighting. I can not see clearly in many indoor environments during the day, particularly on overcast days, and i have consistently poor quality of vision indoors in the evenings due to significant loss of contrast sensitivity. I frequently experience halos around indoor lighting. It is also very difficult to drive at night due to significant starbursting on all light sources, which results in a significant loss of depth perception. I can not enjoy many leisure activities such as watching movies. Watching television with lights on can be quite challenging due to poor quality of the image i see, and going out at night is difficult. None of these vision quality issues can be reliably corrected with glasses or contact lenses, and when dealing with eye drs, i find that my pupils are now considered to be abnormal and i'm lumped in with individuals who have diseased corneas. Although i did sign an informed consent form, this form was treated as a formality and it was represented to me that with the latest wavefront technology, the types of complications detailed in that consent form were mostly a thing of the past. I also expected to be notified if i was at a higher risk for any of those complications -i. E. Due to my larger than average pupils, etc. , but was not adequately notified of my higher than average risk factors. I have spent a significant part of the last year trying to cope with the emotional turmoil and anxiety that have resulted from the loss of visual quality from an elective surgery that was supposed to improve my quality of life. I did not need this surgery, and based on my results, it clearly is not as safe and reliable as it was represented to be.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038014
Lasik laser eye surgery - sight is good, but dryness now coming on two years has not improved.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038017
I had lasik eye surgery approximately 5 years ago. I did not receive 20/20 results, but did experience exceptional clarity after having very poor vision for some time. In the last 6 months, i noticed that my vision seemed to worsen. It was not as clear as it used to be. I could not read as far away as i used to. I am aware that the natural deterioration still occurs due to aging of the eye, but did not expect to experience this at a young age. I have trouble driving at night. My eyes are exceptionally sensitive to light -specifically during nighttime- and i find it hard to focus. Lasik summer - 2003.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038018
Had lasik surgery. Results, eyes tire easily, difficulty focusing, blurred vision, blinking, difficulty reading, avoid evening driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038021
Lasik: developed fungal infection under corneal flap os during one of multiple relifting and smoothing procedures as follow-up to surgery -to remove corneal wrinkles. Referred to ophtho dept; many photographs taken. Prolonged therapy with multiple antifungals. Eventual resolution with residual corneal scarring -luckily out of field of view-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038025
I had lasik surgery on both eyes and woke up with terrific vision. My right eye had been -975- so this was a wonderful day for me. Within 4-6 weeks, i had to have my right eye done again, because it slipped back to about -200. Now, 9 years later, i have eye plugs in both eyes because they are so dry, use drops several times per day, and have to wear glasses to see to drive or watch tv. My right eye has slipped back again, and my left eye is blurry. I have also developed sjorgens syndrome- so i don't know how much the dry eye is from that or the lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038029
Had lasik surgery three years ago. Since then, i have bad vision at night, i see halos around bright lights, and star bursts. Vision during the day is great, but at night it is not very good. I also have dry eyes all the time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038034
Lasik -- i had high myopia -roughly -10 diopters- and large pupils. I did my research, and asked many questions about problems like halos and blurry night vision. I was assured my chances of those problems was low. Sure enough, i still have significant problems with halos and night vision more than 10 years later. And the level of correction "missed" by a significant amount -- 1. 25 on one side, -1. 75 on the other.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038044
Over two years ago i had lasik performed on both my eyes. The dr was thorough in addressing possible hazards and counseled me. I was very near-sited with a serious astigmatism and had worn glasses since 7th grade. Probably needed them well before that. I was better than 20/20 correctable with glasses. After counseling i opted for mono-vision, which would have allowed for book/computer reading in one eye, and distance/driving in the other. The surgery resulted in both eyes being far-sighted. I then underwent 2 - 3 additional corrective surgeries. I am still not satisfied with the results. I cannot file my nails, read most non-computer correspondence/print, properly apply facial cosmetics (eye liner or mascara), etc. Reading glasses do not help with these problems either. Another puzzling complication is that i even have trouble with such mundane tasks as putting away laundry, arranging my closet and dresser drawers, filing personal papers, etc. My eyes tire easily. Prior to the surgery, i could read books, magazines, personal papers (bills, etc), watch tv, etc. All day long with no ill effect. Now i tire within a few hours. This affects my work and earning an income.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038045
Adverse results from lasik. Twenty months after the procedure: blurred vision at all distances, ghost images, halos, starbursts, dry eye, poor contrast sensitivity. Procedure in 2008. Treatment for blepharitis in the next six months. After that, no treatment other than continued use of restasis and intake of fish and flax oil to encourage tear production.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038072
I had lasik to correct near-sightedness, and although i can see well since the surgery, i do have very diminished night vision, very dry eyes, and sometimes have difficulty in focusing on things. This is much more pronounced when my eyes feel dry. If i try to read for any length of time, my eyes dry out a lot, and it's hard to focus on far away objects after that. Before the surgery, i was able to read for hours, and not have this problem. I do wish now, that i had not done the surgery, but it's too late.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038076
Following lasik surgery, i experienced gradually increasing halos and starburst as well as a general deterioration of night vision. Additionally, i continue to experience "floaters" in my field of vision, particularly on the periphery of vision. Finally, my reading vision has degraded inexplicable ( no significant family history of such at my age). The doctors and technicians explained that halos and starbursts might be a temporary problem but assured me that they would stop and fade shortly after the initial procedure - this was over four years ago. The other problems i encountered were not mentioned to me at all. At this time, i am limited in my night driving as a result and forced to employ strong reading glasses in my professional life in order to maintain basic clarity when reading. The facility i used was vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038078
I had lasik surgery to correct nearsightedness in 2004. I have since developed halos and starbursts at night, affecting my vision and my ability to drive. I was given prescription glasses which do not really correct the halos and i cannot drive in the rain.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038080
Lasik procedure was done in 2007. Ok for a couple of days, then eyesight got progressively worse. Many follow-up treatments, later an "enhancement" was done to one eye. Eyesight has gotten progressively worse with that treatment also. Now they are considering doing a third treatment in a couple more months. Thousands of dollars spent and little improvement to vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038083
In 1999, i went in to have lasik eye surgery laser center. The doctor cut a deep flap on the first eye. He then went on to laser and penetrated into my anterior chamber and then aborted surgery. He never did the second eye. I went in with -7. 00 diopters in both eyes and came out with a -22. 00 in my right eye. My doctor was disciplined by the bme in 2006. My present doctors recommend that i have a cornea transplant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037585
It is still too early for me to definitively evaluate my "advanced" -maybe it's called wavefront?- lasik, since the eye doctor tells me that it takes several months to stabilize. I'm trying to be patient, but i'm still waiting. I have severe myopia, and the surgery did seem to improve my vision greatly in that regard. I can read road signs, if the print is large enough, without glasses now, whereas before i would not be able to recognize a person's features if their face was 3 feet away. However, my vision is blurry, and i suspect that is a bit of astigmatism that hopefully can still be corrected if i am allowed to go in for a follow up procedure. The halos around lights at night have subsided but are not totally gone. I am unable to focus a camera perfectly through the viewfinder. I hope that i can have a correction made, but if not i am going to have to ask to get glasses and hope that my vision will be clearer. I did not go into this procedure with unrealistic expectations. At best, i was hoping that i would have incredibly clear vision, like a celebrity in the promotional posters must have, because i know he would not settle for "close enough. " at worst, i was hoping that at least i could function if i lost my glasses, and this is the case. However, i do feel that people should be very careful about what they think will happen after lasik. So far i have not had any complications other than dry eyes, but it is still too early to tell about that either. Now that i talk to my friends who raved about the surgery that they had done years ago, i find out that their vision is not perfect either, but they don't seem too concerned about that. People need to know that it is a complex surgery and to get things perfect is not guaranteed. They either need to read the fine print, with their glasses, or the doctors need to be more honest and spend more time with the pt to make sure they understand all of the details. I am in the midst of several follow up exams at my optometrist. He has pronounced my vision to be 20/20, although i am telling him that my vision is still blurry. He tells me that the eyes are still healing on the cellular level, and that they are dry. I am waiting before i can fully evaluate the effectiveness of the procedure, but it has been several months and i still do not have perfect vision. I do need reading glasses, but at the age of 50 i was expecting this. It is my far distance vision that i am concerned about. Tlc laser eye center, lansing, mi.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037588
Had lasik surgery and had 20/20 vision for the first year or so. Nighttime vision has been increasingly difficult, starbursts around lights has been constant, and overall daytime vision is now around 20/50 after 7 years -failed the eye test 4 years after surgery. Eyes take longer to focus and adjust on objects. I have had to wear glasses or contacts for driving, sports, and most outdoor activities. Overall, i am not happy with the adverse effects that have been happening since i had the surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037589
Experiencing starbursts and halos when looking at light sources after having lasik eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037590
Lasik surgery. I've had 5 different lasik surgeries. I was not pleased with the information given to me. Need for reading glasses. They did not effectively warn me about the acceleration of the need for reading glasses, due to the surgery. I did not need any type of bifocal lenses prior to the surgery. They corrected my vision, so that one eye was designed to read up close and one to see far. This causes all kinds of frustrating problems. I ultimately had more surgeries to correct this and chose to start using reading glasses rather than have the constant strain on one eye, or the other. Need for repeat surgeries. I was also told that, once corrected, i would never need another surgery. I was fine for about 2 years, but then my vision started to decline again. I had another surgery to correct one eye a year ago, and the other eye is now over 20/50 again. I had purchased a life-time adjustment plan on the original surgery. When i called to get the other eye corrected again, they informed me that they no longer support the life-time plan and i would have to pay another $ to correct my bad eye. They have obviously figured out that the surgery doesn't last, and it is costing them money.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037591
Had lasik on both eyes. Right eye - my dominant eye was still slightly blurry at a distance. Wanted distance vision corrected, even if this meant wearing reading glasses. Doctor re-treated 3 months after initial treatment with another lasik procedure. After the second treatment, my eye was much worse. Right eye is now at 20/100. I see 5 or 6 of everything with that eye, and cannot see anything, but a blur at night. Doctors proclaimed the procedure a success due to the fact that with both eyes open i could see 20/20. Suffer from dry eyes, but i am able to treat this with otc drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037592
I first had lasik eye surgery on both eyes in 2003. Within a year after the surgery, my left eye had worsened from 20/20 to where i needed corrective glasses. I went ahead and had the surgery over again in that eye only. Now my left eye sees very well. However, my right eye has over the years begun to get blurry, to where i can no longer see street signs with that eye until i am right under them, and i have trouble reading very large power point presentations. My right eye is very blurry and it causes headaches because my eyes have such different vision. I have resisted going back to the eye doctor for the fear that they will tell me i need to have yet another surgery, or get glasses. It's gotten to where i am not comfortable driving at night, so i am going to get glasses. Since my original surgery, i have read that lasik shouldn't be done on eyes that are potentially still changing. I wonder if that's what happened in my case, since i was only 23 when i first had the surgery. Either way, i am not totally dissatisfied with the procedure, because it is certainly better than before, but i wouldn't say i am completely satisfied, and i am scared of what may continue to happen to my vision in the future
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037594
After i have lasik surgery, i now have starburst when i see lights at night, more so in my left eye, then my right. My night vision is not as good as it used to be. I have the ghosting effect, double images when i am in the dark looking at something that is in the light. From the audience looking at a stage. I have a hard time reading now because of my left eye and the ghosting effect. Things in my left eye are bigger and blurrier than in my right eye. All of these side effects are there even though i technically have 20/20 vision now. I would have preferred to wear contacts for the rest of my life and be able to read than have 20/20 vison and not able to read.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037599
Lasik surgery to both eyes. Procedure was to create "mono-vison" with left eye for distance vision, and right eye for near vision. Initial surgery failed as right eye healed with a focal distance of approx 8 inches instead of the desired 24 inches. After three months for the initial surgery to heal, a second procedure was performed to correct the right eye. This procedure also failed, as the right eye now had a focal distance, approx 30 inches. The surgery center suggested solution was to alter the left eye, which had headed properly following the first procedure. I declined, not wanting to risk my vision any further. The initial assessment was performed by a technician and an optometrist. I did not see the surgeon until just minutes before the procedure. To this day i require eye drops several times a day - a possibility that was not impressed upon me prior to the surgery. After 21 months, i gave up squinting in order to read and returned to glasses. I now wear tri-focals. I believe the decline of my near vision, which was fine before the surgery, was hastened by the surgery. I would not recommend this surgery to anyone.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037601
Approximately, ten years ago i had lasik surgery. After the surgery, i experienced halos and starbursts around lights at night and double vision at night such that headlights and street lights were double. This problem has improved over the years, but, i still have problems at night with lights - milder halos and starbursts. If i had a choice now, i would not have lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037603
Had lasik with customvue on both eyes. Vision is now good, but sometimes unstable esp towards latter part of the day. On-going problems include: dry eye problems and floaters which occurred as a result of the procedure. The dry eye problem has been mostly taken care of by daily eye drops and punctal plugs.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037638
I had lasik surgery - ladarvision 4000, with intralase at eye institute. Since then, i have had starburts at night, severe and painful dry eye, and increased floaters.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037644
Pt had lasik surgery at facility by dr. In 1999, on his left eye. Subsequent to, and as a direct result, of this surgery the pt acquired chronic impaired night vision - starburst, glare, and halos. Additionally, he has dramatically reduced contrast sensitivity. This was confirmed on a contrast sensitivity test in 2000, where his left eye scored 50% but his right eye - unoperated - 100%. Because of the devastating negative outcome the patient decided against the planned lasik surgery on the right eye. The disparity in the visual acuity of his eyes resulted in a secondary condition of anisometropia and he is now dependent upon a contact lens in his unaltered right eye as his only means of balanced, corrected vision. As to a cause of the negative outcome it became clear to the patient after second and third medical opinions that his left pupil size was large and made him a poor candidate for lasik - 6mm ablation zone and patient has 8mm to 9mm pupils on low light. Facility incorrectly assessed his pupil size at 6mm in low light. The patient recalls that his screening by a technician at facility was done only using a card with varying sizes of black circles. He now has learned this to be the most primitive of techniques in assessing pupil size and there is also no standard for pupil measurement - whether devices or techniques - in the u. S. He is also dismayed that dr. Did not independently verify his pupil size at any point prior to surgery. There is apparently no surgical recourse for this outcome of poor night vision, anisometropia and loss of contrast sensitivity, none of which were disclosed in his consent form for the off label use of the summit laser for lasik. In 1999. Lasik surgery performed by dr. At facility, affiliated with another facility-. Dates of use: one day in 1999. Diagnosis or reason for use: correct lasik refractive eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037656
I had lasik surgery in late 2003 by a dr. It was traditional lasik using a b & l technolas laser. The outcome was not as i expected. I share the blame as i signed a document that i fully understood the risks of the surgery. I only did so after being assured, by the physician himself, that i was an excellent candidate and would love the results and that the possibility of complications were extremely small. I was never told about dry eyes, complications of night vision, possibility of ectasia, etc. Needless to say, i feel as though, i was swindled by a very good salesman. I was a -3 to begin with and regressed to a -1 following the surgery. I still struggle with dry eyes today, over three years following the surgery. I have difficulty driving at night because of the halo effect of oncoming traffic lights. I would urge the fda, to put some type of procedure in place that would let the general public know that some individuals wished they never had the surgery. Perhaps have them watch a mandatory dvd of people who have had bad experiences. I think this should be part of the sales pitch that the doctors make when trying to get patients to come to their establishment for the procedure. It's too easy to have the procedure, especially when something as vital as your eye sight is on the line.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037657
I had custom intralase lasik in 2007. My vision in my left eye was 20/40 after surgery. I had an enhancement done in seven months later on my left eye. Several weeks after enhancement, i noticed floaters in both eyes but especially in my left eye. These have not improved in the 6 months or so after my enhancement. These floaters consume most of my waking thoughts. I have researched for hours to find out there is nothing that can be done about them. They have caused me enormous stress and depression. I have a hard time with the thought that i will have to live with these forever. When i had the surgery, there was never any mention of floaters in the papers that i signed. I realize i took a risk having surgery, but is it possible that a study could be done to determine if floaters are indeed caused by lasik? there are so many people that have floaters that are struggling to cope with this garbage in their eyes. I know it is not a life threatening condition but i know that quality of life is definitely diminished. Please take this seriously. I would go back to my glasses days in a heartbeat ! !.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037658
After "all-laser" lasik with wavefront, i am experiencing vertically-stacked double images in both eyes due to astigmatism introduced by the surgery, see halos and flares at night, and i have a corrected vision level of 20/40.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037659
In 2003, i underwent bilateral lasik using the visx customvue platform following the screening by and recommendation of a dr of eye center. I was informed that i was an excellent candidate for the procedure and inquiries as to whether pupil size and/or size of correction were potential adverse considerations in the determination of my candidacy, such concerns were very cursorily and flippantly dismissed and the customvue technology was purported to eliminate the adverse consequences experienced by some, prior lasik procedures - with advertisements showing pictures of rep visual outcomes with and without customvue technology. The result of the procedure was the immediate inducement of visual smearing - far worse than anything ever seen in even the poor outcome representations that customvue was to render obsolete - upon expansion of pupils in indoor, dim lighting and nighttime settings, a directional smearing and loss of contrast sensitivity due to the cumulative effects of such smearing. In inquiries immediately following the surgery, dr alleged that the visual smearing - very precisely and accurately described by me - could potentially be the result of brain / optic nerve issues that would necessitate visiting a neuroophthalmologist that could potentially be extremely serious - and, of course, of no relation to lasik. I visited a neuroophthalmologist who concluded the results to be caused by lasik and that i had extremely dry-eyes. Dr would later cite psychological problems and the need to seek therapy-. The cause of the induced problems were very clear and obvious to those with even a casual understanding of the subject - and even the tiniest degree of honesty, integrity or compassion for human beings-: the ablations were systematically decentered superiorally which, when coupled with inadequacy of optic zone for size of pupils (note: pupils were noted at "16. 0mm" with lights off by pre-qualifying examiner - dr of another place- despite being extremely large even to the casual observer - registering at 8. 0mm by physicians in subsequent visitations; as such, qualifying/referring practitioner likely set the pupil size equal to the size of the treatment zone so as to conclude one to be a good candidate, not because it is actually the size of my pupils and amount of tissue removed, accounted for all of the visual problems experienced. This is very clearly evidenced by all topographies; this was not the product a biomechanical instability of the flap manifesting itself as an undesirable healing pattern but by an incorrect alignment as achieved by the laser platform and the practicing physician, which is supported by artemis scans and the immediacy of symptomatic descriptions. The flagrant lies following the procedure caused tremendous mental/psychological distress - i am not a complete idiot, so i had a sense that i was being lied to by first dr and assorted referring physicians concerning the cause and prognoses of the devastating and life-altering results - due to the fact that i soon realized i could not obtain the truth concerning my current condition from anyone in the industry - i visited many throughout the country - due to their interests in protecting their colleagues and their profession. What i encountered during my efforts to work with the medical community - the willingness to do and perpetuate harm at any cost for - albeit tremendous - personal gain; greed manifested by a desire to perpetuate a practice at any cost and any level of dishonesty and obfuscation in the midst of those literally crying for help or at least acknowledgement of problems induced if help was not possible - beyond any description - was something i will never forget. I obtained confirmation of the truth of what was done to me only upon traveling overseas - to london, england - a tremendously painful and difficult trip given the dry-eye and visual disruptions - apparently severing the code of silence on my travel across the pond. Perhaps even more importantly, the lies perpetuated by the lasik community during my inquiries immediately following the surgery very likely caused a further life-long devastating condition: dry-eye. First dr prescribed alphagan p approx 10 days post-op - without the disclosure of its potentially devastating dry-eye effects if applied to recently ablated eyes during a crucial time/window when corneal nerve regeneration is of utmost importance - due to the devastating visual effects - and election not to disclose the reason for the directional smearing and consequent ineffectiveness and inadvisability of pupil-constricting medication as a post-op, long-term solution given the cause-; he then prescribed c-pilocarpine due to lack of efficacy. Dr holzman then prescribed - within approx 2 months of the surgery - corneal gas permeable lenses; the practitioner to whom he referred me had no experience fitting such lenses in post-lasik cases. The pain of lens wear was truly excruciating. All of these courses of actions prescribed likely retarded corneal nerve regeneration during the time period in which such regeneration is crucial, resulting in the -extreme, irreversible- symptomatic onset of dry-eye pain, which progressively worsened to a constant and debilitating state.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037660
I had lasik surgery in 1998 and following, have post lasik ectasia in both eyes. My vision has progressed to the point where my left eye is legally blind, and i function using my right eye, which gives me 20/60 vision but with severe astigmatism, so i have constant disabling headaches. I also wear an eye patch on my left eye because my brain cannot process the images produced by the eyes at the same time - anisometropia - without getting even more severe, intolerable headaches. Because of the constant headaches and low vision, i cannot work or attend school and i do not qualify for disability. The surgery - performed, using a visx laser - has absolutely ruined my life. I am not a good candidate for a cornea transplant because i have extremely dry eye, also exacerbated by lasik surgery. This surgery has destroyed my life. Please contact me if you want further info.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037661
I received bilateral lasik surgery with the visx inc. Star excimer laser system and have had significant ongoing vision problems post-op. I had no surgical complications (flap problems, infection, etc). However, i have significant higher - order abberations, resulting in poor vision acuity and quality and double vision (daytime and night), and glare - especially at night. My best corrected vision with lens and/or spectacles is much poorer compared to pre-surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037662
Surgeon cut a short flap during lasik procedure and did not abort procedure. Eye was lasered in only one half of intended area, and the underside of the flap was also lasered, resulting in a severe permanent scar in the field of vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037663
I need contacts for both eyes, but i had lasik on my right eye only due to my flexible spending account situation. I now have a harder time seeing out of that eye at night because of the starbursting that was supposed to go away after i stopped using the medicated eyedrops. The doctor told me it would be a day or two after i stopped using the eyedrops that my starbursting would go away. It has now been three weeks since surgery, and there is no improvement with the starbursting. My left eye still sees normally at night when i wear my contact. My right eye vision has been corrected, but i notice smaller starbursts during the day and big starbursts at night. I was planning to have the left eye done as well, but i don't want to do it until i know my right eye night vision improves. I might be part of the 5% who experience permanent starbursting after the surgery since the effect is taking longer to go away than the doctor expected. I have a true before and after comparison and i am not yet satisfied with the results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037785
I have had three lasik surgeries to correct my vision. At no time did i ever achieve the "20/20" ideal. My eyes keep regressing. After the first surgery, they poo-poo'd me and told me to use more eye drops. I thought this was absurd as i was not going to use eye drops every few mins just to see, and my eyes did not feel dry. Since the first, i have had bilateral lasik and a third in just one eye. Within one year of the final surgery, i was back in glasses to see. I was now in bifocals, which was not needed before. I heard the article on npr radio this morning. If this is the info you need, i will be happy to research my records for more detail.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037786
Received lasik eye surgery on my right eye. Prior to my appointment i had many scans from the tlc ctr on my right eye. I had all the required pre-op appointments. The day of my surgery, the doctor put the ring around my eye. The device was off ctr and had to be adjusted and put back on. My eye ball swelled and i had a large red ring where the device was. The lasik was performed. Outcome was good. Two months later, i awoke to great pain in my right eye. Later that morning, i noticed that i was missing vision from the ctr of my eye up. I was like someone pulled a shade over half my eye. I went to the eye doctor for my follow up visit, and i mentioned this new development. My retina detached. I had to see a specialist for a scleral buckle. This reattached my retina. However, i no longer have 20/20 vision in my right eye. I was told they can reperform the lasik to recorrect my vision. After all that, i went through i do not think i will have it redone. I have since gone into a deep depression and now i am being treated for that. I still have to see the retinal specialist for check up. I have very poor night vision in my right eye. In the paper work, i signed for the surgery for lasik procedure it did say that there was a possibility of detached retina, however, i did not understand what that meant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037787
I don't remember the exact date, but it was sometime in summer of 2000. I had lasik surgery and i'm semi-unhappy. Vision is not as good now as i had hoped it would remain, even though it was about 20/15 for some time after the surgery. Severe dry eyes and halo effect, uncomfortable at times with night vision/driving. Surgical results still better than contacts were for me, but overall wish i had stuck with glasses, i think. I continue to use restasis eye drops for dry eyes and experience much discomfort most mornings wear glasses to bring vision back up to 20/20. Must have 20/20 for my job.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039137
I had lasik surgery to correct my vision. I now suffer from extreme severe dry eyes. I use drops every 1-4 minutes in each eye. The surgeon still has me using the sterile drops and has me taking various supplements. He has also permanently plugged my tear ducts. Our monthly bills for drops and supplements! i am also in constant pain. I cannot drive at night or see well at dark. My day activities have been altered drastically. I cannot do so many activities due to eye pain, and needing to stop and use drops every 1-4 minutes. My vision is fuzzy at all times, except for about 5 seconds after administering the drops. I cannot read road signs or see faces. Of course i fear the worst, which is blindness. Because of pain and extreme light sensitivity i have to always wear dark glasses. As far as i can tell from my records, i was never asked or tested for dry eyes prior to the surgery. I thought i was suffering alone until the recent reports have been highlighted. My husband, parents, and relatives are chiropractors. They have me on the best supplements for dry eye, but nothing has helped much. If you know of anything else out there, i would be most thankful for your advice. Respectfully. I don't know the name of the machine used, but the date was 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039138
I flew to have perform lasik on both eyes. Since, today's date is 2008 and going on 9 years, my vision has been distorted, i have dry eye syndrome, decentered flaps cut from the microkeratome blade, and an uneven laser reshapement, permanently thinning out my only corneas further ruining my vision for life. I have spent, trying to return my vision to normal with no luck. I have traveled around the world and have seen the best doctors, all with no fix in line. My own dr, has lawsuits and has continued to lie to myself and my family about the lasik procedure going wrong, very wrong, horrifically wrong. I want a complete investigation of my dr's lawsuits, his lies, and his unprofessional ways. He has harassed my family, attempted to sue us to the tune -he failed- because of my website that warns the masses about lasik and lasik doctors like him. I want justice. Lasik will never be safe because it is still unpredictable surgery. One person it works for, and the next go blind or have complications beyond control to deal with. At least with contacts or glasses, you can get by with sane vision. The consent form is a joke at best. It does not give the consumer all of the known and unk symptoms, side effects, and long -term problems that it should be giving them. It protects doctor while injuring the pt. Complaint and investigation on: the vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039140
In 1992, i lost my vision after refractive surgery - rk. In early october i had gone to a "free" seminar to gather info before i saw a dr. I had pre-existing scar tissue on my left eye but dr said "no problem", and we proceeded with bilateral refractive surgery. I did not have good vision from the start. I was told that "things have not settled down yet. We can always perform an enhancement. " i struggled with my duties at home and work. In 1993, i went to another city to see another dr -a referral from dr(first)-. He performed a prk on my left eye with later plans to surgically improve the right eye. At that time second dr told me that dr(first) made the cuts in my eyes too deep and too long. My left eye now had vision worse than pre-prk and was covered with scar tissue from the laser. In 1995, i went on medical leave from my surgical nursing position and had a corneal transplant. During that year, i filed for disability retirement. In 1996, i went to jury trial -case, medical malpractice. I was the victim made to look like a perpetrator. We lost the case and threw ourselves into debt. Dr(first) told me i was a good candidate for refractive surgery, that i would have good results and could throw away my glasses. He never told me there was no turning back from this surgery. He never mentioned the star burst, night blindness, double vision or painful dry eye. He never mentioned that i would not be able to care for my three children. I live the nightmare every day and cringe when i see the same advertising today as when i had my disastrous eye surgery. Dates of use: 1992 - 1993. Diagnosis or reason for use: rk cutting device and laser for prk procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039141
Event: bilateral lasik refractive surgery to correct nearsightedness. Outcome: initially corrected to 20/25; about 3 months after surgery, regression began, causing nearsightedness to return and requiring use of expensive custom contact lenses to achieve 20/20 vision. Night vision severly damaged: corneal surfaces healed with a non-smooth surface, causing severe higher order aberrations -hoas-, which cause visual disturbances, including: large starbursts when looking toward any light source, such as car headlights. Multiple -more than 20- images of bright objects. Much poorer ability to discriminate objects in dark or dim rooms. Night vision disturbances and hoas cannot be corrected with glasses, or with most types of contact lenses. Require expensive custom-made large diameter rigid gas permeable -rgp- contact lenses. Annual expense for rgp lenses and special cleaning solutions: for first pair of lenses -including professional fees- with duplicate lenses for each lens. Annual cost of cleaning solutions and devices; dry eye caused by lasik causes discomfort when using corrective contact lenses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1047150
My lasik experience: after initial surgery in 1998, then enhancement in 1999, my vision in both eyes, uncorrected was 20/20. This was truly a miracle for those of us so dependent upon contacts and glasses. I remember disposing of all my old contact lenses and extra cases. No more lens cleaning, scrambling for glasses at night, occasional discomfort etc. This visual quality of life lasted 9 months. Then, gradually the sight in my right eye deteriorated to 20/100 by late 1999. I also noticed declining vision in my left eye, just to a lesser degree. My lasik process from the outset was being handled by both my local od and surgeons from the nearby medical school clinic. Neither could understand this change but both concluded that in early 2000, i should undergo a 2nd enhancement on both eyes. The outcome of this 2nd enhancement made no improvement and further thinned my cornea to less than 250m r and 275m l. Eventually, ectasia or keratectasia became the diagnosis and rgp lenses were prescribed. My average best corrected post lasik vision with a rose k rgp in the left eye is 20/25 and a boston scleral lens in the r is 20/40. Typically, i am able to wear my lenses with reasonable comfort up to 15 hours daily. Unsuccessful results: unsuccessful results as in my situation, tend to lead to various complications such as ectasia or keratectasia, dry eye problems, depth perception difficulties, and in general, intense disappointment. Most likely, the real reason for unsuccessful outcomes in the pre lasik screening and preparation process was not adequate and the surgeon was too aggressive in the degree of correction. Also, as is the case in all vocations, there are some physicians who are simply not qualified. Another contributing factor to complications after lasik surgery can occasionally be the result of obsolete or faulty calibrated equipment. Lastly, is the fact that fundamental mistakes are made even by the most qualified doctors. I believe and again emphasize that if attentive pre lasik screening is adhered to, reasonable margins for error are considered, and detailed checks and balances are built into the lasik process from beginning to end, complications as a result of lasik surgery can be significantly mitigated. When you get to the stage many of us are in, anger, frustration, and major disappointment is natural. We ask; why did this happen? what should i do? what will be the final result, i. E. Will i end up blind? although still very difficult, i try to objectively negate or offset many of these disappointments and concerns by concentrating first by simply coping but secondly and most importantly, focusing on the prospects that better treatments for ectasia, kerataectasis, and keratoconus are being constantly developed and in the not too distant future, a long-term viable solution will emerge. Detailed history: 1998: preop exam, manifest r -7. 00-1. 75x030 20/20. L -6. 75-2. 25x162 20/20. On the following month: two week status post lasik. Visual acuity without correction 20/25 r and l. Manifest r -0. 50 sphere 20/20. L -0. 75 sphere 20/20. In 1999: three months status post lasik. Visual acuity with out correction 20/20 in the right eye, 20/25 on the left eye. Manifest r -1. 00 sphere 20/20. L -0. 25-0. 75x130 20/20. On approx three months later: six months post lasik. Visual acuity with out correction 20/50 in the right eye, 20/25 on the left. Manifest r -1. 00-0. 25x010, l -0. 25-0. 75x140; 20/20 vision in both eyes. On approx six months later: visual acuity with out correction r 20/60, l 20/40. Manifest r -1. 00 sphere. L -0. 75-1. 00x145, 20/20 acuity in each eye. In 2000: 24 hr post lasik enhancement. Visual acuity with out correction 20/20 in the right eye, 20/20-1 in the left eye. Manifest r plano-0. 50x050 and 20/20 vision l -0. 25 sphere 20/20. Two wks post lasik enhancement. Visual acuity 20/20- right and left eye. Manifest r plano-0. 50x055, l-0. 50 sphere 20/20 vision in both eyes. In 2000: three months post lasik enhancement. Visual acuity without correction 20/25 in the right eye, 20/20 in the left eye. Manifest r plano-0. 75x055 20/20 vision and l plano-0. 50x140 20/20 vision. On approx three months later: six months post lasik enhancement. Visual acuity without correction 20/30 in the right eye and 20/25 in the left eye. Manifest r -0. 25-1. 00x065 and l -0. 25-0. 50x130 20/20 vision in both eyes. In 2001: one yr post lasik enhancement. Visual acuity without correction 20/100 in the right eye and 20/50 in the left. Manifest r plano-3. 50x086 and l-0. 25-0. 50x130 with 20/20 vision in both eyes. On the following month: preop for lasik enhancement #2. Visual acuity without correction 20/100 in the right eye and 20/32 in the left. Manifest r was -0. 50-3. 25x081 and l -0. 25-0. 50x 130 for 20/20-3 in the right eye and 20/20 in the left. On approx seven months later: visual acuity without correction was 20/100 in the right eye and 20/32 in the left. Manifest r -0. 25-4. 25x094 for 20/25 acuity and l -0. 50-0. 75x115 for 20/20. On sixteen days later: lasik enhancement #2. On the following month: two weeks post lasik enhancement #2. Visual acuity without correction. Was 20/50 in the right eye and 20/25 in the left. Manifest r plano -0. 75 x 040 with a variable response for best corrected visual acuity of 20/50 and l plano -0. 75x135 for 20/20. On approx three months later: three months post lasik enhancement #2. Visual acuity without correction was 20/50 in the right eye and 20/25 in the left. Manifest r -0. 50x1. 00x060 for 20/40 acuity and l pano-0. 75x 135 for 20/25 visual acuity. Since the enhancement #2, continuous central pek worse in the right eye than the left. In 2002: five months post lasik enhancement #2. Visual acuity without correction was 20/100 in the right eye and 20/30 in the left. Manifest r -0. 75- 2. 75x35 for 20/20 visual acuity. Irregular steepening in the central cornea, mild pek, confirmed central comea ectasia. On the following month: contact lens fit od that achieved 20/25 vision. One and a half months later: change in visual acuity in the left eye. Manifest refraction l plano 1. 75x 50. On four weeks later: initiated rgp fitting of the left eye with visual acuity of 20/20.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039109
I had lasik surgery performed in 2005. A year's long problem with dry eye syndrome, itching of the eyes, there were days i came home from work and wanted to rip my eyes out, they itched so bad. Had lots of blurred vision, was put on restatsis for 6-9 months. The hospital where i work -i'm a veteran- put permanent plugs in both bottom tear ducts to help with dry eyes, but this created a lot of fluid build-up at night to where my vision was even blurrier. My provider who performed the surgery eventually told me to blow dry my eyes every morning. What a joke, i paid him 4,000. 00 to have all these problems. If i had this to do over again, i would never have had this procedure performed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039110
Lasik surgery that has resulted in ghosted vision, reduced night vision, halos, reduced vision in dim light, and loss of contrast in dim light. Diagnosis or reason for use: nearsighted -4. 25, no longer able to tolerate contacts, glasses cause.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039111
Had a lasik procedure completed that resulted in reduced vision in my left eye and improved vision in my right eye. In the process of creating the corneal flap, the entire cornea came loose and had to be stabilized with a contact after the procedure. The complication was labeled normal, and my claims of blurred vision and poor outcome were not taken seriously by the facility that completed the procedure. However, i am a nurse and had a chance to speak with an ophthalmologist regarding the procedure. The ophthalmologist attributed the poor outcome entirely to the error of the unsuccessful flap creation in the left eye for the laser. Lasik surgery in 2007 laser.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039112
I had lasik surgery in 2006, and have suffered significant eye health issues ever since. While my eyesight is good, i developed superior limbic keratoconjunctivitis -slk- and severe dry eye syndrome. According to webmd, "it is believed that slk is present secondary to superior bulbar conjunctiva laxity, which induces inflammatory changes from mechanical soft tissue microtrauma. " ophthalmologists treated the slk with drops and environmental modifications for a full year with no success. I have since reluctantly had additional surgery - conjunctiva resection on both eyes, but am still experiencing problems. My ophthalmologists say they cannot begin to treat the dry eye syndrome until the slk is brought under control. Unfortunately, the lack of an adequate tear film aggravates the slk. I believe this vicious circle was directly caused by lasik surgery. Neither the surgeon nor the surgical center where i rec'd the lasik adequately warned me of the dangers. Although it was not bothering me at the time, they measured my tear production, determined i had dry eyes prior to surgery and started a course of restasis. Knowing what i do now, that alone should have disqualified me from the procedure. I urge the fda to mandate stronger criteria to disqualify people for this procedure and to promote additional pt education prior to surgery. Dose or amount: bilateral surgery, frequency: once.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039113
I received lasik eye surgery two years ago. Since that time, i have had three "touch-ups" due to poor results. These poor results include: - blurred vision - dry, itchy eyes - a feeling that something is "in there" - extreme sensitivity to light - fear of night driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039114
After effect: night halos, especially while driving; dry eye; noticeable weakening of correction within 18 months of procedure. Glasses required for night driving. Pre-procedure: despite requests, i was never able to speak directly with the operative surgeon until moments before the procedure and then, only just briefly. There was no substantive contact with the surgeon, ever, even post surgery. Also, pre-procedure, i was shuffled between two optometrists in the office and had trouble getting consistent info about the details of my correction. It felt like a mill; i was just one of the masses. P. S. Despite the problems, i feel that lasik requires a risk-benefit assessment for each pt. I suffer these after effects, but if i had the option to choose the procedure again, i would probably do it. The benefits outweigh the after effects. For others this may not be true. It is an assessment that each individual must make. If i could do anything differently, it would be to interview more facilities/physicians, instead of just going with the one who i thought had the best record. I should say, also, that i chose mono-vision so that one eye sees far away and the other sees close. I do not need glasses for reading or distance, only for driving at night due to halos. I do have some trouble with intermediate distances, say three to four feet.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039121
Lasik surgery flap not sufficient to proceed in left eye, device did not fit eyelid. Redid surgery in several months, 2006, using another technique. Painful dry eye resulted immediately in both eyes from original lasik surgery and has not remitted fully, although, improved with daily use of expensive eye drops - cyclosporin.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039122
I was overcorrected in my left eye as a result of wavefront prk with the visx excimer laser. Not only that i have, terrible side effects in both eyes -gash- which greatly affect my night vision and vision in low light situations. Mild dry eye is also problematic. For a procedure that was supposed to make my life easier, it has made it much more difficult and complex on a daily basis. I so very wish that i could go back to my vision with glasses. Not a day goes by that i am not reminded of the adverse events following my prk. Date of use: 2006.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038013
Laser vision correction surgery. An inexperienced surgeon or defective machine cut flap too deep leaving a bulge on my eye. Second surgery in 2005 -by the same surgeon- to remove bulge, damages the cornea and leaves me with the uncurable eye disease pinguecula. The surgeon contends i have dry eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038108
Dear sir/madam: please be informed that i had a lasik surgery in late 1996 at the hospital by a dr. I have written you a certified letter on 04/28/2008 in reference to the problem, and i have also written certified letters through the years to medical entities, and political officers. Dr did a malicious act by masking half of my cornea and created fluids under the cornea flap to conceal the immediate results. I have been all over the world to see if something can be done to correct my cornea, but nothing can be done. In my letter to you, i have enclosed tomographies, so you can see that only a human hand could have covered half of the cornea and create fluids under the flap. Currently, my cornea is irritated, i can't wear contact lenses, and i can see triple images. I hope your agency shall investigate this matter and bring dr. Mcdonald and other doctors like her to justice. If doctors like dr are left unchecked, the problems doctors injuring patients will not go away, and we will have an injured handicapped and unhealthy society. Sincerely.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038117
Lasik, prk eye surgery left eye prk, right eye lasik. Extreme difference from l to r eye. Left eye also still has bad astigmatism, had to get prescription reading glasses for one eye to slow down headaches. I paid the extra per eye, for lifetime touch up. After waiting 1 yr, i went back to see if they could balance out the eye better and was told no. Unless they get worse than 20/40 they would not do it. That was not told to me at the time of surgery. Why pay the extra money then? i am now very light sensitive. As my md told me, photo-phobic. The need for sunglasses is all the time and i have even had a few episodes that were so severe that i had to pull over when driving. It is interfering with my work. Floaters or what i would term as dirt floating around in the eyes, which is really loose blood vessels. I was told that these would go away after a few weeks as they started shortly after the surgery. It's been a year and a half and there's still a lot of them.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038120
After lasix surg: i had preexisting ectasia which went undiagnosed by the dr. He took 2 thermal photos on two separate appointments that now we know clearly show red, thin areas of the cornea. After the first surgery, i could not see as well as before surgery and dr kept saying it will get better. Never did. He did what he called "an enhancement" which he said would re-center my vision, removing even more tissue. He was going to do a third procedure "enhancement" and was stopped by the head of the eye dept at the out of town hosp where the surgery was done. I see halos, star bursts and now have to wear contacts to hold the cornea down. Dry eyes is a huge problem. Night driving is pretty much not possible except in emergency. Long drives to parents and friends is not something i can do anymore. Lost 30 peripheral vision as well. Just about ruined my life and dr never said, i'm sorry. No help at all.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038128
I had lasik surgery two years ago. Mostly it has been perfect, but my night vision is awful now. It used to be very good. It's almost scary to drive at night. Especially when it's raining. I never had that problem before. It's like when the sun shines just right into a camera and the light spreads and blocks stuff out. Also i see the halos around duller lights. My vision during the day is fantastic.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038131
Lasik surgery. I was not a good candidate having a size 7 pupil and -10 1/2 refraction with astigmatism. My night vision is impaired and have to stop driving at night. Have starbursts and very dry eyes which affects vision. Had extreme pain after surgery and 4 months of very little vision. Ten years later i have macular degeneration in one eye which has further debilitated my sight. The surgeon said i was an excellent candidate which was clearly not the case.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038099
Following lasik surgery, i have had problems with serious dry eyes. Every morning i must use eye drops and most nights as well. In addition, in the dark light objects have sunbursts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038103
I was talked into having rk-radial keratotomy- on my eyes by dr. He said, he never had a problem with any of his surgeries and guaranteed me a successful outcome. After the surgery, however, my eyes became very fatigued and sore. He said that i was reading from the twenty-twenty line on the eye chart and that this problem is in my head. He offered no support or guidance in this matter whatsoever, and practically dismissed me. I was shocked. Now i was left with sore, tired, fatigued eyes and no answers, since this was a new procedure in our area. So i began a journey to try and find a solution. This journey has taken me to numerous prominent eye surgeons. The have prescribed soft and hard contact lenses, glasses, performed ck-conductive keratoplasty-, lasik twice, and nothing has really corrected the problem. The pitfalls of corrective eye surgery need to be honestly discussed by these eye doctors, not covered up by misleading advertising and hype. Thank you for your time and concern in this matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038104
Lasik surgery. Extreme pain in eyes lasting 2 weeks. Had to stay in darkened room for a month. Since operation every thing is dim. Very difficult to drive at night, halo and sparkler effect from lights, extreme dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038106
Lasik surgery was performed with less than desired results. The patient requested clear distance vision and the results were clear close-up vision with maintained distance vision requiring corrective lenses. Lasik was performed again on the left eye with better results, but still less than desired. In 2007, cataract surgery was performed on both eyes to obtain desired results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1036129
Was supposed to have lasik surgery, but had prk because the md said i did not have enough cornea. Prk in early 2008. That night the bandaid lens fell out of my left eye and formed a corneal abrasion. After many visits back to the md, and he stating everything looked good for about a month. I visited another md because my eye looked like it was going to fall out of the socket. The 2nd md stated i had a terrible infection behind the cornea. He treated me aggressively for about 2 weeks. No improvement with many eye drops and daily visits to the md. The md stated that he had to do an emergency corneal transplant or i might loose my eye. I have a permanent disability 20/70 in my left eye. I continue to have discomfort and i am recovering from shingles of the eye. My outcome for vision is not good. I had 2 other md visits and they both agreed regular lasik surgery was much better, and i had enough cornea flap. I feel that the first md from lasik plus in tampa fl neglected my care and eye. He never addressed an infection. I was put on large dosages of pain killers and tranquilizers and sleeping pills for the pain. Each time i would visit the md, he would say 2 more weeks and you will be healed. If i would have not gone to another md, i would have lost my eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037947
Laser: VISX S4
In 2007, i underwent lasik vision correction surgery. I was screened and declared a perfect candidate for the surgery. The surgery itself went exactly as planned with no "surgical" complications. According to the dr, the healing process also went normal and i was declared to have an excellent outcome due to my low refractive error. However, in spite of this, the results of this surgery were actually disastrous. Although my post-surgical refractive error is quite low, the surgery induced a significant level of higher order aberrations, including a highly abnormal level of spherical aberration and coma due to a correction zone that is much smaller than my scotopic pupil size. I see fine in direct sunlight and natural lighting, but have difficulty seeing clearly under normal levels of indoor or artificial lighting. I can not see clearly in many indoor environments during the day, particularly on overcast days, and i have consistently poor quality of vision indoors in the evenings due to significant loss of contrast sensitivity. I frequently experience halos around indoor lighting. It is also very difficult to drive at night due to significant starbursting on all light sources, which results in a significant loss of depth perception. I can not enjoy many leisure activities such as watching movies. Watching television with lights on can be quite challenging due to poor quality of the image i see, and going out at night is difficult. None of these vision quality issues can be reliably corrected with glasses or contact lenses, and when dealing with eye drs, i find that my pupils are now considered to be abnormal and i'm lumped in with individuals who have diseased corneas. Although i did sign an informed consent form, this form was treated as a formality and it was represented to me that with the latest wavefront technology, the types of complications detailed in that consent form were mostly a thing of the past. I also expected to be notified if i was at a higher risk for any of those complications -i. E. Due to my larger than average pupils, etc. , but was not adequately notified of my higher than average risk factors. I have spent a significant part of the last year trying to cope with the emotional turmoil and anxiety that have resulted from the loss of visual quality from an elective surgery that was supposed to improve my quality of life. I did not need this surgery, and based on my results, it clearly is not as safe and reliable as it was represented to be.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038014
Lasik laser eye surgery - sight is good, but dryness now coming on two years has not improved.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038017
I had lasik eye surgery approximately 5 years ago. I did not receive 20/20 results, but did experience exceptional clarity after having very poor vision for some time. In the last 6 months, i noticed that my vision seemed to worsen. It was not as clear as it used to be. I could not read as far away as i used to. I am aware that the natural deterioration still occurs due to aging of the eye, but did not expect to experience this at a young age. I have trouble driving at night. My eyes are exceptionally sensitive to light -specifically during nighttime- and i find it hard to focus. Lasik summer - 2003.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038018
Had lasik surgery. Results, eyes tire easily, difficulty focusing, blurred vision, blinking, difficulty reading, avoid evening driving.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038021
Lasik: developed fungal infection under corneal flap os during one of multiple relifting and smoothing procedures as follow-up to surgery -to remove corneal wrinkles. Referred to ophtho dept; many photographs taken. Prolonged therapy with multiple antifungals. Eventual resolution with residual corneal scarring -luckily out of field of view-.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038025
I had lasik surgery on both eyes and woke up with terrific vision. My right eye had been -975- so this was a wonderful day for me. Within 4-6 weeks, i had to have my right eye done again, because it slipped back to about -200. Now, 9 years later, i have eye plugs in both eyes because they are so dry, use drops several times per day, and have to wear glasses to see to drive or watch tv. My right eye has slipped back again, and my left eye is blurry. I have also developed sjorgens syndrome- so i don't know how much the dry eye is from that or the lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038029
Had lasik surgery three years ago. Since then, i have bad vision at night, i see halos around bright lights, and star bursts. Vision during the day is great, but at night it is not very good. I also have dry eyes all the time.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038034
Lasik -- i had high myopia -roughly -10 diopters- and large pupils. I did my research, and asked many questions about problems like halos and blurry night vision. I was assured my chances of those problems was low. Sure enough, i still have significant problems with halos and night vision more than 10 years later. And the level of correction "missed" by a significant amount -- 1. 25 on one side, -1. 75 on the other.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038044
Over two years ago i had lasik performed on both my eyes. The dr was thorough in addressing possible hazards and counseled me. I was very near-sited with a serious astigmatism and had worn glasses since 7th grade. Probably needed them well before that. I was better than 20/20 correctable with glasses. After counseling i opted for mono-vision, which would have allowed for book/computer reading in one eye, and distance/driving in the other. The surgery resulted in both eyes being far-sighted. I then underwent 2 - 3 additional corrective surgeries. I am still not satisfied with the results. I cannot file my nails, read most non-computer correspondence/print, properly apply facial cosmetics (eye liner or mascara), etc. Reading glasses do not help with these problems either. Another puzzling complication is that i even have trouble with such mundane tasks as putting away laundry, arranging my closet and dresser drawers, filing personal papers, etc. My eyes tire easily. Prior to the surgery, i could read books, magazines, personal papers (bills, etc), watch tv, etc. All day long with no ill effect. Now i tire within a few hours. This affects my work and earning an income.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038045
Adverse results from lasik. Twenty months after the procedure: blurred vision at all distances, ghost images, halos, starbursts, dry eye, poor contrast sensitivity. Procedure in 2008. Treatment for blepharitis in the next six months. After that, no treatment other than continued use of restasis and intake of fish and flax oil to encourage tear production.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038072
I had lasik to correct near-sightedness, and although i can see well since the surgery, i do have very diminished night vision, very dry eyes, and sometimes have difficulty in focusing on things. This is much more pronounced when my eyes feel dry. If i try to read for any length of time, my eyes dry out a lot, and it's hard to focus on far away objects after that. Before the surgery, i was able to read for hours, and not have this problem. I do wish now, that i had not done the surgery, but it's too late.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038076
Following lasik surgery, i experienced gradually increasing halos and starburst as well as a general deterioration of night vision. Additionally, i continue to experience "floaters" in my field of vision, particularly on the periphery of vision. Finally, my reading vision has degraded inexplicable ( no significant family history of such at my age). The doctors and technicians explained that halos and starbursts might be a temporary problem but assured me that they would stop and fade shortly after the initial procedure - this was over four years ago. The other problems i encountered were not mentioned to me at all. At this time, i am limited in my night driving as a result and forced to employ strong reading glasses in my professional life in order to maintain basic clarity when reading. The facility i used was vision center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038078
I had lasik surgery to correct nearsightedness in 2004. I have since developed halos and starbursts at night, affecting my vision and my ability to drive. I was given prescription glasses which do not really correct the halos and i cannot drive in the rain.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038080
Lasik procedure was done in 2007. Ok for a couple of days, then eyesight got progressively worse. Many follow-up treatments, later an "enhancement" was done to one eye. Eyesight has gotten progressively worse with that treatment also. Now they are considering doing a third treatment in a couple more months. Thousands of dollars spent and little improvement to vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1038083
In 1999, i went in to have lasik eye surgery laser center. The doctor cut a deep flap on the first eye. He then went on to laser and penetrated into my anterior chamber and then aborted surgery. He never did the second eye. I went in with -7. 00 diopters in both eyes and came out with a -22. 00 in my right eye. My doctor was disciplined by the bme in 2006. My present doctors recommend that i have a cornea transplant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037585
It is still too early for me to definitively evaluate my "advanced" -maybe it's called wavefront?- lasik, since the eye doctor tells me that it takes several months to stabilize. I'm trying to be patient, but i'm still waiting. I have severe myopia, and the surgery did seem to improve my vision greatly in that regard. I can read road signs, if the print is large enough, without glasses now, whereas before i would not be able to recognize a person's features if their face was 3 feet away. However, my vision is blurry, and i suspect that is a bit of astigmatism that hopefully can still be corrected if i am allowed to go in for a follow up procedure. The halos around lights at night have subsided but are not totally gone. I am unable to focus a camera perfectly through the viewfinder. I hope that i can have a correction made, but if not i am going to have to ask to get glasses and hope that my vision will be clearer. I did not go into this procedure with unrealistic expectations. At best, i was hoping that i would have incredibly clear vision, like a celebrity in the promotional posters must have, because i know he would not settle for "close enough. " at worst, i was hoping that at least i could function if i lost my glasses, and this is the case. However, i do feel that people should be very careful about what they think will happen after lasik. So far i have not had any complications other than dry eyes, but it is still too early to tell about that either. Now that i talk to my friends who raved about the surgery that they had done years ago, i find out that their vision is not perfect either, but they don't seem too concerned about that. People need to know that it is a complex surgery and to get things perfect is not guaranteed. They either need to read the fine print, with their glasses, or the doctors need to be more honest and spend more time with the pt to make sure they understand all of the details. I am in the midst of several follow up exams at my optometrist. He has pronounced my vision to be 20/20, although i am telling him that my vision is still blurry. He tells me that the eyes are still healing on the cellular level, and that they are dry. I am waiting before i can fully evaluate the effectiveness of the procedure, but it has been several months and i still do not have perfect vision. I do need reading glasses, but at the age of 50 i was expecting this. It is my far distance vision that i am concerned about. Tlc laser eye center, lansing, mi.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037588
Had lasik surgery and had 20/20 vision for the first year or so. Nighttime vision has been increasingly difficult, starbursts around lights has been constant, and overall daytime vision is now around 20/50 after 7 years -failed the eye test 4 years after surgery. Eyes take longer to focus and adjust on objects. I have had to wear glasses or contacts for driving, sports, and most outdoor activities. Overall, i am not happy with the adverse effects that have been happening since i had the surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037589
Experiencing starbursts and halos when looking at light sources after having lasik eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037590
Lasik surgery. I've had 5 different lasik surgeries. I was not pleased with the information given to me. Need for reading glasses. They did not effectively warn me about the acceleration of the need for reading glasses, due to the surgery. I did not need any type of bifocal lenses prior to the surgery. They corrected my vision, so that one eye was designed to read up close and one to see far. This causes all kinds of frustrating problems. I ultimately had more surgeries to correct this and chose to start using reading glasses rather than have the constant strain on one eye, or the other. Need for repeat surgeries. I was also told that, once corrected, i would never need another surgery. I was fine for about 2 years, but then my vision started to decline again. I had another surgery to correct one eye a year ago, and the other eye is now over 20/50 again. I had purchased a life-time adjustment plan on the original surgery. When i called to get the other eye corrected again, they informed me that they no longer support the life-time plan and i would have to pay another $ to correct my bad eye. They have obviously figured out that the surgery doesn't last, and it is costing them money.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037591
Had lasik on both eyes. Right eye - my dominant eye was still slightly blurry at a distance. Wanted distance vision corrected, even if this meant wearing reading glasses. Doctor re-treated 3 months after initial treatment with another lasik procedure. After the second treatment, my eye was much worse. Right eye is now at 20/100. I see 5 or 6 of everything with that eye, and cannot see anything, but a blur at night. Doctors proclaimed the procedure a success due to the fact that with both eyes open i could see 20/20. Suffer from dry eyes, but i am able to treat this with otc drops.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037592
I first had lasik eye surgery on both eyes in 2003. Within a year after the surgery, my left eye had worsened from 20/20 to where i needed corrective glasses. I went ahead and had the surgery over again in that eye only. Now my left eye sees very well. However, my right eye has over the years begun to get blurry, to where i can no longer see street signs with that eye until i am right under them, and i have trouble reading very large power point presentations. My right eye is very blurry and it causes headaches because my eyes have such different vision. I have resisted going back to the eye doctor for the fear that they will tell me i need to have yet another surgery, or get glasses. It's gotten to where i am not comfortable driving at night, so i am going to get glasses. Since my original surgery, i have read that lasik shouldn't be done on eyes that are potentially still changing. I wonder if that's what happened in my case, since i was only 23 when i first had the surgery. Either way, i am not totally dissatisfied with the procedure, because it is certainly better than before, but i wouldn't say i am completely satisfied, and i am scared of what may continue to happen to my vision in the future
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037594
After i have lasik surgery, i now have starburst when i see lights at night, more so in my left eye, then my right. My night vision is not as good as it used to be. I have the ghosting effect, double images when i am in the dark looking at something that is in the light. From the audience looking at a stage. I have a hard time reading now because of my left eye and the ghosting effect. Things in my left eye are bigger and blurrier than in my right eye. All of these side effects are there even though i technically have 20/20 vision now. I would have preferred to wear contacts for the rest of my life and be able to read than have 20/20 vison and not able to read.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037599
Lasik surgery to both eyes. Procedure was to create "mono-vison" with left eye for distance vision, and right eye for near vision. Initial surgery failed as right eye healed with a focal distance of approx 8 inches instead of the desired 24 inches. After three months for the initial surgery to heal, a second procedure was performed to correct the right eye. This procedure also failed, as the right eye now had a focal distance, approx 30 inches. The surgery center suggested solution was to alter the left eye, which had headed properly following the first procedure. I declined, not wanting to risk my vision any further. The initial assessment was performed by a technician and an optometrist. I did not see the surgeon until just minutes before the procedure. To this day i require eye drops several times a day - a possibility that was not impressed upon me prior to the surgery. After 21 months, i gave up squinting in order to read and returned to glasses. I now wear tri-focals. I believe the decline of my near vision, which was fine before the surgery, was hastened by the surgery. I would not recommend this surgery to anyone.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037601
Approximately, ten years ago i had lasik surgery. After the surgery, i experienced halos and starbursts around lights at night and double vision at night such that headlights and street lights were double. This problem has improved over the years, but, i still have problems at night with lights - milder halos and starbursts. If i had a choice now, i would not have lasik surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037603
Had lasik with customvue on both eyes. Vision is now good, but sometimes unstable esp towards latter part of the day. On-going problems include: dry eye problems and floaters which occurred as a result of the procedure. The dry eye problem has been mostly taken care of by daily eye drops and punctal plugs.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037638
I had lasik surgery - ladarvision 4000, with intralase at eye institute. Since then, i have had starburts at night, severe and painful dry eye, and increased floaters.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037644
Pt had lasik surgery at facility by dr. In 1999, on his left eye. Subsequent to, and as a direct result, of this surgery the pt acquired chronic impaired night vision - starburst, glare, and halos. Additionally, he has dramatically reduced contrast sensitivity. This was confirmed on a contrast sensitivity test in 2000, where his left eye scored 50% but his right eye - unoperated - 100%. Because of the devastating negative outcome the patient decided against the planned lasik surgery on the right eye. The disparity in the visual acuity of his eyes resulted in a secondary condition of anisometropia and he is now dependent upon a contact lens in his unaltered right eye as his only means of balanced, corrected vision. As to a cause of the negative outcome it became clear to the patient after second and third medical opinions that his left pupil size was large and made him a poor candidate for lasik - 6mm ablation zone and patient has 8mm to 9mm pupils on low light. Facility incorrectly assessed his pupil size at 6mm in low light. The patient recalls that his screening by a technician at facility was done only using a card with varying sizes of black circles. He now has learned this to be the most primitive of techniques in assessing pupil size and there is also no standard for pupil measurement - whether devices or techniques - in the u. S. He is also dismayed that dr. Did not independently verify his pupil size at any point prior to surgery. There is apparently no surgical recourse for this outcome of poor night vision, anisometropia and loss of contrast sensitivity, none of which were disclosed in his consent form for the off label use of the summit laser for lasik. In 1999. Lasik surgery performed by dr. At facility, affiliated with another facility-. Dates of use: one day in 1999. Diagnosis or reason for use: correct lasik refractive eye surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037656
I had lasik surgery in late 2003 by a dr. It was traditional lasik using a b & l technolas laser. The outcome was not as i expected. I share the blame as i signed a document that i fully understood the risks of the surgery. I only did so after being assured, by the physician himself, that i was an excellent candidate and would love the results and that the possibility of complications were extremely small. I was never told about dry eyes, complications of night vision, possibility of ectasia, etc. Needless to say, i feel as though, i was swindled by a very good salesman. I was a -3 to begin with and regressed to a -1 following the surgery. I still struggle with dry eyes today, over three years following the surgery. I have difficulty driving at night because of the halo effect of oncoming traffic lights. I would urge the fda, to put some type of procedure in place that would let the general public know that some individuals wished they never had the surgery. Perhaps have them watch a mandatory dvd of people who have had bad experiences. I think this should be part of the sales pitch that the doctors make when trying to get patients to come to their establishment for the procedure. It's too easy to have the procedure, especially when something as vital as your eye sight is on the line.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037657
I had custom intralase lasik in 2007. My vision in my left eye was 20/40 after surgery. I had an enhancement done in seven months later on my left eye. Several weeks after enhancement, i noticed floaters in both eyes but especially in my left eye. These have not improved in the 6 months or so after my enhancement. These floaters consume most of my waking thoughts. I have researched for hours to find out there is nothing that can be done about them. They have caused me enormous stress and depression. I have a hard time with the thought that i will have to live with these forever. When i had the surgery, there was never any mention of floaters in the papers that i signed. I realize i took a risk having surgery, but is it possible that a study could be done to determine if floaters are indeed caused by lasik? there are so many people that have floaters that are struggling to cope with this garbage in their eyes. I know it is not a life threatening condition but i know that quality of life is definitely diminished. Please take this seriously. I would go back to my glasses days in a heartbeat ! !.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037658
After "all-laser" lasik with wavefront, i am experiencing vertically-stacked double images in both eyes due to astigmatism introduced by the surgery, see halos and flares at night, and i have a corrected vision level of 20/40.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037659
In 2003, i underwent bilateral lasik using the visx customvue platform following the screening by and recommendation of a dr of eye center. I was informed that i was an excellent candidate for the procedure and inquiries as to whether pupil size and/or size of correction were potential adverse considerations in the determination of my candidacy, such concerns were very cursorily and flippantly dismissed and the customvue technology was purported to eliminate the adverse consequences experienced by some, prior lasik procedures - with advertisements showing pictures of rep visual outcomes with and without customvue technology. The result of the procedure was the immediate inducement of visual smearing - far worse than anything ever seen in even the poor outcome representations that customvue was to render obsolete - upon expansion of pupils in indoor, dim lighting and nighttime settings, a directional smearing and loss of contrast sensitivity due to the cumulative effects of such smearing. In inquiries immediately following the surgery, dr alleged that the visual smearing - very precisely and accurately described by me - could potentially be the result of brain / optic nerve issues that would necessitate visiting a neuroophthalmologist that could potentially be extremely serious - and, of course, of no relation to lasik. I visited a neuroophthalmologist who concluded the results to be caused by lasik and that i had extremely dry-eyes. Dr would later cite psychological problems and the need to seek therapy-. The cause of the induced problems were very clear and obvious to those with even a casual understanding of the subject - and even the tiniest degree of honesty, integrity or compassion for human beings-: the ablations were systematically decentered superiorally which, when coupled with inadequacy of optic zone for size of pupils (note: pupils were noted at "16. 0mm" with lights off by pre-qualifying examiner - dr of another place- despite being extremely large even to the casual observer - registering at 8. 0mm by physicians in subsequent visitations; as such, qualifying/referring practitioner likely set the pupil size equal to the size of the treatment zone so as to conclude one to be a good candidate, not because it is actually the size of my pupils and amount of tissue removed, accounted for all of the visual problems experienced. This is very clearly evidenced by all topographies; this was not the product a biomechanical instability of the flap manifesting itself as an undesirable healing pattern but by an incorrect alignment as achieved by the laser platform and the practicing physician, which is supported by artemis scans and the immediacy of symptomatic descriptions. The flagrant lies following the procedure caused tremendous mental/psychological distress - i am not a complete idiot, so i had a sense that i was being lied to by first dr and assorted referring physicians concerning the cause and prognoses of the devastating and life-altering results - due to the fact that i soon realized i could not obtain the truth concerning my current condition from anyone in the industry - i visited many throughout the country - due to their interests in protecting their colleagues and their profession. What i encountered during my efforts to work with the medical community - the willingness to do and perpetuate harm at any cost for - albeit tremendous - personal gain; greed manifested by a desire to perpetuate a practice at any cost and any level of dishonesty and obfuscation in the midst of those literally crying for help or at least acknowledgement of problems induced if help was not possible - beyond any description - was something i will never forget. I obtained confirmation of the truth of what was done to me only upon traveling overseas - to london, england - a tremendously painful and difficult trip given the dry-eye and visual disruptions - apparently severing the code of silence on my travel across the pond. Perhaps even more importantly, the lies perpetuated by the lasik community during my inquiries immediately following the surgery very likely caused a further life-long devastating condition: dry-eye. First dr prescribed alphagan p approx 10 days post-op - without the disclosure of its potentially devastating dry-eye effects if applied to recently ablated eyes during a crucial time/window when corneal nerve regeneration is of utmost importance - due to the devastating visual effects - and election not to disclose the reason for the directional smearing and consequent ineffectiveness and inadvisability of pupil-constricting medication as a post-op, long-term solution given the cause-; he then prescribed c-pilocarpine due to lack of efficacy. Dr holzman then prescribed - within approx 2 months of the surgery - corneal gas permeable lenses; the practitioner to whom he referred me had no experience fitting such lenses in post-lasik cases. The pain of lens wear was truly excruciating. All of these courses of actions prescribed likely retarded corneal nerve regeneration during the time period in which such regeneration is crucial, resulting in the -extreme, irreversible- symptomatic onset of dry-eye pain, which progressively worsened to a constant and debilitating state.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037660
I had lasik surgery in 1998 and following, have post lasik ectasia in both eyes. My vision has progressed to the point where my left eye is legally blind, and i function using my right eye, which gives me 20/60 vision but with severe astigmatism, so i have constant disabling headaches. I also wear an eye patch on my left eye because my brain cannot process the images produced by the eyes at the same time - anisometropia - without getting even more severe, intolerable headaches. Because of the constant headaches and low vision, i cannot work or attend school and i do not qualify for disability. The surgery - performed, using a visx laser - has absolutely ruined my life. I am not a good candidate for a cornea transplant because i have extremely dry eye, also exacerbated by lasik surgery. This surgery has destroyed my life. Please contact me if you want further info.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037661
I received bilateral lasik surgery with the visx inc. Star excimer laser system and have had significant ongoing vision problems post-op. I had no surgical complications (flap problems, infection, etc). However, i have significant higher - order abberations, resulting in poor vision acuity and quality and double vision (daytime and night), and glare - especially at night. My best corrected vision with lens and/or spectacles is much poorer compared to pre-surgery.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037662
Surgeon cut a short flap during lasik procedure and did not abort procedure. Eye was lasered in only one half of intended area, and the underside of the flap was also lasered, resulting in a severe permanent scar in the field of vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037663
I need contacts for both eyes, but i had lasik on my right eye only due to my flexible spending account situation. I now have a harder time seeing out of that eye at night because of the starbursting that was supposed to go away after i stopped using the medicated eyedrops. The doctor told me it would be a day or two after i stopped using the eyedrops that my starbursting would go away. It has now been three weeks since surgery, and there is no improvement with the starbursting. My left eye still sees normally at night when i wear my contact. My right eye vision has been corrected, but i notice smaller starbursts during the day and big starbursts at night. I was planning to have the left eye done as well, but i don't want to do it until i know my right eye night vision improves. I might be part of the 5% who experience permanent starbursting after the surgery since the effect is taking longer to go away than the doctor expected. I have a true before and after comparison and i am not yet satisfied with the results.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037785
I have had three lasik surgeries to correct my vision. At no time did i ever achieve the "20/20" ideal. My eyes keep regressing. After the first surgery, they poo-poo'd me and told me to use more eye drops. I thought this was absurd as i was not going to use eye drops every few mins just to see, and my eyes did not feel dry. Since the first, i have had bilateral lasik and a third in just one eye. Within one year of the final surgery, i was back in glasses to see. I was now in bifocals, which was not needed before. I heard the article on npr radio this morning. If this is the info you need, i will be happy to research my records for more detail.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037786
Received lasik eye surgery on my right eye. Prior to my appointment i had many scans from the tlc ctr on my right eye. I had all the required pre-op appointments. The day of my surgery, the doctor put the ring around my eye. The device was off ctr and had to be adjusted and put back on. My eye ball swelled and i had a large red ring where the device was. The lasik was performed. Outcome was good. Two months later, i awoke to great pain in my right eye. Later that morning, i noticed that i was missing vision from the ctr of my eye up. I was like someone pulled a shade over half my eye. I went to the eye doctor for my follow up visit, and i mentioned this new development. My retina detached. I had to see a specialist for a scleral buckle. This reattached my retina. However, i no longer have 20/20 vision in my right eye. I was told they can reperform the lasik to recorrect my vision. After all that, i went through i do not think i will have it redone. I have since gone into a deep depression and now i am being treated for that. I still have to see the retinal specialist for check up. I have very poor night vision in my right eye. In the paper work, i signed for the surgery for lasik procedure it did say that there was a possibility of detached retina, however, i did not understand what that meant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037787
I don't remember the exact date, but it was sometime in summer of 2000. I had lasik surgery and i'm semi-unhappy. Vision is not as good now as i had hoped it would remain, even though it was about 20/15 for some time after the surgery. Severe dry eyes and halo effect, uncomfortable at times with night vision/driving. Surgical results still better than contacts were for me, but overall wish i had stuck with glasses, i think. I continue to use restasis eye drops for dry eyes and experience much discomfort most mornings wear glasses to bring vision back up to 20/20. Must have 20/20 for my job.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037788
Re: lasik surgery - adverse outcome. I understand the fda is investigating lasik surgery and is soliciting feedback from consumers who have had poor outcomes. I am reporting an adverse result. Here's my story: had the procedure done in 1999. The procedure was a failure from day one. I never fully corrected my vision and has deteriorated ever since. Initially after the procedure, i got by without glasses or contacts, but it was a real struggle to see. I then had to very regrettably go back to contacts, but had to wear soft "toric" lenses which i had never had to wear before. I had some astigmatism pre-op but, the lasik made it even worse. In the past two yrs, i have become fully contact lens intolerant. They do not correct my vision, they actually horribly distort it. I have tried many different types, including "hybrid" lenses for post surgical patients. I must now wear glasses 100% to see. My corneas are severely distorted and i have a bulging thin spot at the bottom which precludes any further procedures. I am not correctable to 20/20 with glasses, so bottom line, lasik has been an absolute disaster for me. I have gone for multiple opinions and have been diagnosed as having lasik ectasia, keratoconus, pellucid marginal degeneration, pmd, and "we don't know why it didn't work. " i was told that i should never have had the surgery looking at my pre-op topographies today, but i had gone for 3 evals before doing the surgery and no one had expressed any concerns or that i wasn't a "candidate. " so on top of having an extremely poor outcome, my other complaints are dry eye, and lots of junk in my vision, floaters and flashes. It has also been pretty devastating emotionally to hear all the glowing lasik stories, while i now have fewer corrective options than i did before the surgery, my bcva isn't event 20/20. There are also the time and personal expense issues of flying to see specialists, going to multiple appointments and the absurdly expensive treatments, intacs, c3r and special lenses that don't even work.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037789
Underwent lasik procedure; unfortunately have redeveloped vision deficit and halo with difficulty with night vision especially while driving; now using contact lenses again but with less myopia than before.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037790
I am glad to know fda is looking at lasik side effects. I feel i gained more from the surgery than i lost and i never filed a complaint with my doctor. I thought i was informed of all the risks, but i think things were not known at the time. While i had 20/20 vision for several years and the initial results were very dramatic, my eyesight has worsened over time. I began wearing slightly corrective glasses in 2002. Now i wear glasses most of the time. It isn't absolutely necessary in the daytime, but since my vision is not perfect, so it helps me, esp. With my weaker eye. It went back to being the weaker eye. More seriously is the fact that my night vision is seriously impaired. I cannot drive without my glasses at night. I do fine in the city where there is a lot of light at night. And, rarely found myself driving in darker places. But, i discovered a couple of years ago that i cannot drive in areas where it is darker and single lights serve the purpose of lighting. Single highway lamps or other cars headlights completely disperse and obstruct my vision. The light bursts out in lines in many directions. Seriously, i will not drive at night under those circumstances.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037796
Following lasik surgery, my eyes no longer produce natural tears. To control the extreme dryness, use eyedrops throughout the day. I also need to wake up throughout the night to use the eyedrops; typically eight times per night. I use one large bottle of eyedrops per week. In the two years following the surgery, i also have experienced frequent headaches and frequent eye infections.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037797
I had lasik surgery and was promised 20/20 vision with no need for glasses. Two yrs later, i still experience dry eyes, need for nearly constant wear of closeup glasses for 1st 10 feet, and fuzzy night vision. I am a physician and waited to have the surgery and only let myself do it because, it was explained to me that all the kinks were worked out of the procedure. I am able to see distance without glasses, but if i was clearly explained the downsides which i experience i would have waited more yrs for further improvement in the procedure. Unfortunately, medicine in this country has become big, maybe biggest, business and doctors, medical industry, hospitals are not under any real self, government, or fda ethical, moral quality control, in my field of orthopedics millions of unnecessary mris, xrays, procedure, surgeries and labeling of pts making them sicker are being promoted by the medical conglomerate and by pts. Until real understanding of the human being is incorporated into the world of medicine, and not just collections of body parts, with all kinds of disease labels thrown at people by other people, doctors, and media--great perpetuation of fears and all kinds of pills, tests, procedure, and surgeries are being generated without the real higher wisdom that we should be incorporating in health promotion and care.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037798
I had lasik surgery on my left eye only despite my ophthalmologist's urging that i do both eyes. I had read of the possibility that i would see an aura around lights at night after surgery and did not want to take the chance that would happen on both eyes. I had it done on my eye with the worse vision, 14 diopters. After it was done my vision in that eye was about 1 diopter. It progressed to 3. 5 diopters fairly rapidly and is now at 6. 5 diopters. My complaint is that i read in an ophthalmology text book about six months after the surgery that surgery was not recommended for people with vision of 8 diopters or worse and also that it was not recommended for people of my age. I had the surgery done at a med ctr and the physician should have known this info, but he did not inform me even though i did ask the questions.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037799
I had lasik surgery and did not require glasses to read while driving. I only needed glasses for close reading. After 2007, i realized that this was changing. I needed glasses for more things and my vision was degrading to returning to need glasses fulltime and at the same prescription before the laser surgery. I contacted the dr. 's office where it was done for a followup and this change and was told that if it had to be "redone" i would again have to pay for another surgery as the time was past the "two years". I then went to an ophthalmologist and was told that my glasses were of the same strength, of the ones i wore before the surgery, and that i had a cornea problem and had stages of cataracts. I was shocked since i thought that the exam at the time of the surgery would have shown these problems and would have shown perhaps an alternate type of surgery, or addressing this condition first. Vision after laser surgery and correction did not sustain.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037800
Within a month of my lasik procedure my night driving became impaired by starbursts which were made worse if it was raining. I had to wear very low-prescription, non-glare coated glasses for night driving. Also, the surgery couldn't completely correct my astigmatism, and in the last year my vision got worse, so i am back in glasses every day now. I had a very good doctor and he warned me of all of this, so none of it really surprises me, though it does disappoint me that my only option is to have the procedure again and the results would presumably be better given that the procedure is more precise now than it was 9 years ago. Lasik procedure on both eyes in 1999.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037803
I had lasik and it resulted in permanent halos, loss of night vision, and dry-eye. The dry-eye is mild and has improved with time, but has continued. The halos and night vision are severe. I have larger than average pupils, and i've been told that the problem is that they expand to be larger than the surgical scar, which causes light to refract and cause a halo or aura around lights or light-colored objects in dim light. Dim light basically means anything less than very bright sunlight. I used to have unusually good night vision, and it's far more limited now, that's what i regret the most. My measured vision regressed after the fact, but i expected that - it was very bad before. I still wear glasses, but at a much lesser prescription. I don't count that as an adverse reaction, but i do think that many people don't realize that if you have terrible vision to begin with you are less likely to get perfect vision from the surgery. I did know that and accepted it. Due to the halos, i could not drive at night for years, and i only risk it now because i've been able to get much better anti-glare for my glasses that helps a lot. The major problem that i have now is that i can't read street signs until i'm very close because the white wording blurs due to halos. Also, pupils shrink as you age, so that may have helped. My doctor spent a lot of time with me and was very thorough before and after - i don't blame him for this problem. I was warned that i had a higher likelihood than normal to get the long-term halo effects, but was also told it was unlikely. I did not know exactly what the halos wee, and i do not think people realized how likely they were with my type of eye structure at the time. The halo effect and loss of night vision have had a permanent adverse effect on my life and ability to function. I think people should be warned about how troublesome this is, and that there should possibly be stricter guidelines against people with large pupils having this surgery, at least until they figure out how to lessen the chances of this happening. Maybe some sort of drawing or film could be made showing what they might end up seeing at night to explain what the halos are could help. My doctor was very careful about measuring how thick my corneas were before agreeing to do the surgery - maybe pupil size should be an add'l first check. Lasik surgery, 1999.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037804
After having lasik surgery on my left eye, which was -13, or about 20/200-, my vision seemed to have improved. However, since the removal of the eye patch, the vision has had a "pulsating" sensation in which objects are almost in focus, then get grossly out of focus every second or so. This is constant. Plus, i have perpetual halos and flares at night as well as extreme dry eye. I've since learned from other ophthalmologists that the surgeon had over-corrected and the cornea is now permanently flat, rather than curved. They also told me that i should've been rejected as a candidate due to my extreme myopia. I'm thankful that i had the foresight - no pun intended - to have him operate on only one eye and not both. My reasoning was that if the surgery went well, i'd have him do the right eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037806
Got lasik. I now have large, distracting halos around bright light sources - hi contrast. Especially noticeable at night. I also have a large number of "floaters" in my eyes. I believe these are free, coagulated blood cells, but not sure. They are especially noticeable when looking at a evenly lit, uniform surface, such as a clear blue sky or a white wall. I would estimate about 10 distinct floaters in each eye. I also suffer from very dry eyes - i tend to use eye drops before i go to bed and when i wake up. I can barely keep my eyes open when i first wake-up, they are that dry. I use an over the counter eye lubricant prod. I am a photographer, so some of these uncomfortable adverse effects are very noticeable to me, and i sometimes feel like they are driving me crazy.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037807
Although i'm not certain about the date of my lasik eye surgery, there were problems from this surgery. Initially, the doctor reversed the monovision, mistakenly treating my right eye for near vision and my left eye for distance. Afterwards, when i couldn't see clearly, the doctor realized his mistake so he repeated the surgery on my right eye to make it for distance, too. Therefore, i didn't end up with monovision because of his mistake. Another problem was that my vision was approx 20/40 in one eye and 20/30 in the other until approx two yrs after the surgery. The doctor advised me to put drops in my eyes every day to dilate my pupils, so i could see better. He said i would need to wear sunglasses because of the light entering my eyes from this dilation. Needless to say, i didn't do this ridiculous procedure! however, after approx two yrs, my vision has improved to an acceptable level. This litany of problems sound like i went to a fly-by-night clinic, however, i went to a respected ophthalmologist.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037808
Had lasik surgery. Adverse results include extreme dry eye (has eased somewhat, especially with the use of flaxseed oil pills), starbursts, halos, double-vision and lack of contrast. Vision varies greatly based on the amount of light - much worse at night and in dim light - and amount of moisture in the eye. Each blink can produce a different quality of vision. If there is someone standing in front of me in dim light, and there is brighter light behind them, i can hardly see what's in the foreground. Even with the aid of glasses or contacts, my vision can no longer be corrected to that i had before. If i could go back and do it again, i would not have the surgery. I was probably a poor candidate, with large pupils and poor vision - 6. 5, but no one mentioned that at the time. One realy frustrating thing is that the eye tests indicate my vision is much better than what i know to be true, because they don't measure the effect of the starbursts, etc. , and they don't test night vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037809
One eye was only corrected to half the vision it should have been. The flap on the other eye was not smoothed out resulting in wrinkles on the flap that cause impaired vision. I have terrible night vision, see halos and starbursts around every bright light. In very muddled light vision is very difficult. Dry eyes are very common and i suffer from that.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037810
Lasik surgery was done on both eyes. Monovision was chosen so that i could read out of right eye - i had been using monovision contacts. Surgery resulted in double vision in left eye which is the distance eye. This means i still need to wear glasses while driving. Traffic lights and headlights appear double and blurry. Also now have dry eyes. The positive side is that i feel safe when sailing or swimming. I was legally blind without contacts before. I went back to the dr and she said that the result is fine. I disagree but am afraid to get it adjusted.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037811
Cataract surgery with lasik touchup resulted in very poor night vision and substantial increase in floaters.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037812
I got lasik eye surgery in early 2006 - (that's not the exact date), i have no vision issues, thank god, but what i do have is permanent dry eye disorder. The dry eye disorder is hell at times, it's very painful and i get headaches, it is disabling because i have a lot of trouble working a full day, because the ventilation and wind hitting my eyes makes them very dry and then painful. It's always there and never goes away, it's permanent. I use drops all the time and have all four punctal plugs, plugged but they're still dry. When the headaches come it's disabling and interferes in my life. I just find it hard going on with a normal life with this dry eye disease, it never goes away. If i would have known this would happen, i wouldn't have gotten lasik at all, i would be much happier with my glasses.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037813
My mother had a lasik surgery. The doctor told her it was a successful procedure, but she has developed extreme dry eyes, lost vision and her life is in complete disaster. She has not been able to work since due to the condition in her eyes. The doctor says her eyes are ok, giving the impression she is exagerating the symptoms. She was not informed correctly prior to the operation, but now it's too late for her. She is a dentist and had to close her office. We hope this doesn't happen to more people.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037814
On the date of the procedure, after correcting my right eye without event, i experienced a "button hole" cut on left eye during lasik surgery, due to what i was told was an "equipment malfunction. " the procedure was stopped and i went home to heal. The procedure was repeated on the left eye 6 months later; however, that eye has never focused well again - (near or far) - and is susceptible to blurriness and irritation. In addition, night vision is diminished.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037816
I had lasik eye surgery, and now my vision has regressed to a significant point - left dist. 20/25, right dist. 20/30 - and my optometrist warns me against attempting corrective surgery again. She claims my cornea is already too flat and if i sought surgery again it could have very negative effects on my vision, such as having a "fun-house mirror effect" where i would never see normally again. When i received my surgery, debris was caught in my left eye and i had to go back two weeks later to have it removed. The surgeons had to once again cut into my eye to lift a flap and clear the debris. The contract stated that i could get lifetime correction if needed if i sent yearly eye exams to them. My mother did this, but when i called the surgeon's office i was told they didn't have any of the faxed exams on file and i would have to bring them copies. Dates of use: 2003. Diagnosis or reason for use: poor eye sight.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037817
I had lasik laser eye surgery. When the procedure was being done, the flap that was cut on my left eye was very thin. Then, the computer on the laser machine crashed. It took a few minutes to re-boot. While re-booting, the doctor tried to keep my eye saturated with fluids. However, when the very thin flap was replaced, it had a wrinkle in it. The wrinkle caused blurry vision in a starry pattern. I had a second surgery done to smooth out the wrinkle, and it helped, but the vision in that eye will always be a bit blurry. Also, an overall consequence of lasik that i was not adequately informed of before the surgery is dry eyes. It is especially difficult overnight, and especially if i've had a alcohol to drink before going to bed. I can detect a drying of eyes after just one glass of wine. Sometimes my eyes get so dry overnight that i wake up with incredible stinging eyes in the middle of the night. I keep drops on my nightstand so that i can immediately put drops in my eyes when i wake up. I reach for the drops with my eyes closed.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037819
I was treated for vision correction using lasik. My vision improved from 20/400 to 20/25 and 20/30. I still wear glasses all the time to achieve 20/20 in both eyes. My main problems are starbursts around car headlights and other bright objects. Car headlights bother me even on bright sunny days. My night vision has been greatly reduced and my eyes are dry all the time. My dr. Explained the potential complications but these seemed to occur at a very low rate and surely wouldn't happen to me.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037820
Prk surgery to both eyes performed to correct astigmatism and near-sighted vision. Prior hx of auto-immune problems, fibromyalgia, sjogrens syndrome, rosacea, osteoporosis, celiac, year-round allergies, treated with elestat, allegra, flonase. After prk surgery, dry-eye syndrome and blepharitis has persisted, despite treatment with restasis qid since 2006, warm compress and topical over the counter eye drops. Recent treatment with doxycycline 100 mg bid blepharitis and rosacea, with good results, but not resolution. Also continued low light issues, with loss of resolution. Starbursts and halos resolved after about 8 months with ability to drive at night and for more than 2 hours at a time. Md was aware of the above diagnosis except sjogrens, but apparently did not read the chart prior to surgery and did not advise the pt of dry eye possibility. Vision and dry eye symptoms are variable, depending on level of allergy reactions, humidity/dryness of air, fatigue and amount of vision use especially computer viewing. Pt is currently treated with restatis tid, over the counter lubricating drops prn, doxycycline 100 mg bid, warm compresses to the eyes qd.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037821
Lasik surgery didn't work out. I was over-corrected from near-sighted to severely far sighted. "correction" procedure was performed four months later with little improvement. Now i have to wear corrective lens and get used to completely the opposite problem i had before lasik.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037822
Bad lasik. Unlike many others, i read everything my doctor gave me and much on the web. I was ready for the halos and starburst, but hopeful that they would not occur. Not only did i get the halos and starburst, but i also had two others, and one far worse problem that was never disclosed to me by my doctor. Lasik also can cause your near vision to become worse. Immediately after the surgery i needed my reading glasses. When i asked my doctor, he indicated, "oh yes, that sometimes happens" and explained the reason why. Would have been nice to know before the surgery. Far worse was a severe increase in floaters in one eye again never reported. It is so bad that i literally cannot see out of that eye at certain times, and even in the best of cases, it's like someone put a piece of wax paper in front of that eye. My surgeon was widely known and highly regarded even appearing on abc's 20/20 as a fixit of other peoples problems, and he turned out to be a charlatan. Dates of use: 2002. Diagnosis or reason for use: see better.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037823
In 1999, i had corneal tear when cutting the "flap" during the lasik procedure. After the full procedure, i had extreme star-burst images and full double images. These persisted for about 3 years when they started to decrease in severity. I eventually needed a prescription for trifocal glasses to correct the faulty vision. I still have a minor to moderate star-bursts and some double imaging. The doctor who performed the lasik procedure finally dropped me from his care. He didn't want me interacting with the other pts about my bad lasik experience. I have recently been diagnosed in 2008 - as having chronic corneal erosion syndrome caused by the lasik procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037824
After lasik surgery, i now have very poor night vision and will most likely have to stop driving at night within the next few years. I see halos and star bursts. It appears after some digging and research on my own, i have unusually large pupil such that the lasik cut/treatment area was smaller than the pupil. So during the day and bright light the pupil contracts to a smaller size, and is within the treated area and my vision is o. K. It's not 20/20, but closer to 20/30 or 20/35. However as it gets darker or cloudy, my pupil expands and the outer part of the pupil goes outside of the treated area and my vision gets worse. Then in total darkness at night a larger portion of my pupil is outside of the treated area, causing the halos and star bursts. Sometimes it's so bad that i have to turn on the inside car light to help shrink my pupil and to shrink the star bursts. Knowing what i know now, my doctor should have told me that this would be a side effect of having a large pupil. There is a good chance that knowing this and the severe outcome, i might not have had the procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037825
Lasik procedure resulted in the following problems. I was extremely nearsighted -something like 20/1000- with very thick glasses and somewhat dry eyes to start with. So dry, that i have difficulty with contact lenses. I sought the lasik because the weight of the glasses was putting constant pressure on my sinus, and i was in discomfort most of the time. Correction to 20/20 in one eye and 20/40 in the other did not work for me. Dr should have tested me with glasses first. So had to have a second procedure within a few months to change the 20/40 eye to 20/20. Double vision in right eye and a huge "flare" in that eye as well -- if i looked at a stop light at night, there was huge flare of light running off the top of the round light. This required a third lasik procedure a year later -- different dr and another $4,000. Both problems were substantially improved. Extreme dry eye - needed to use refresh tears every 10 to 15 minutes. Could barely open my eye in the am. Ongoing problems. Extreme dry eye has improved with restasis rx, which i expect to be using forever. Still also use refresh tears frequently. Blurry vision - mostly related to dryness. Night glare - with newer headlights coming at me, limits night driving. I have developed a cataract in the eye that was lasik'd three times. Not blaming the lasik for this, but current dr is very hesitant to treat the cataract due to the thinness of remaining cornea -?- material. A newer version of lasik machine was available at the time of my procedure. The dr did not inform me of that fact. From what i have learned much of my problem would not have happened with the newer machine.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037826
I had lasik surgery in 2000. My vision before surgery was considered legally blind. I wore contacts prior to the surgery but my dr said that because of eye infections, i would go blind if i continued wearing contacts. I decided to get the lasik procedure. I was the 95th person my dr had performed the surgery in his facility. I was given valium before the surgery which made me jittery and made my palms sweat - the opposite reaction they were expecting. The surgery went well and the first couple of post-operative visits were fine, just a little blurry. Within a few days, i had a blurry spot where i could not see in my right eye. If i turned my head sometimes i could see fine from that eye. Anyway, after weeks of appointment, steroids and consultations with other physicians, it was determined that i had oil -sweat- under my flap. It eventually cleared up. I have had major halos at night. Oncoming traffic from a distance appears as large firework burts. When traffic approaches, my eye contracts and my vision is better. When i walk in the dark outside, small lights appear huge, such as doorbell lights seem big when i'm walking down the street. I have been told i have huge pupils. My present ophthalmologist says i have the largest pupils she has ever seen. My night vision is the pits. I see large fireworks. In addition, i was now told that when the lasik physician performed the surgery, he did not make my left eye my dominate distance eye. I am left-handed. I now have cataracts which were diagnosed. I was told that the operative site for the lasik is smaller than the area my eye dilates and that the blurriness comes when my eyes dilate, at night and i'm seeing my old vision on the outside of my pupil. Before my surgery, i wore a -9 in contact lenses. I do see lots better than i did without glasses but the night vision problems are permanent, and i usually avoid most night driving. I have some new driving glasses which helps a little bit, mostly because they bring my left eye event with my right eye or make my left eye more dominant.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037830
Lasik surgery: extreme dryness both eyes after surgery. Quality of life impaired. Therapy continues: restasis, warm compresses on eyes, systane, doxycycline.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037831
I was told i was a candidate for lasik surgery - did not inform myself well enough - took my doctor's recommendation and had it done. I suffer daily, wake up in the middle of the night - can't hardly open my eyes. Its acutely painful. I go through bottles of artificial tears as drinking water. Many, many regrets.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037832
In 2000, i elected to have lasik surgery performed. The surgeon had difficulty with the equipment used to stabilize the eye before surgery, making multiple attempts at 'suctioning' the eye until it was bruised and bloodshot. Since i was approximately the 40th person to have lasik surgery performed by this doctor and on the same machine as all previous patients, it may not have been working correctly. What ultimately happened was that my right eye was 'corrected' to 20/20 vision, my left eye, however, was 'over-corrected'. Instead now of being near-sighted in my left eye, following the procedure, i was now far-sighted to approximately 20/40. This has made for difficulty in focus, especially at night. I generally see a double image of any light at night, stars, the moon, headlights, street lights, etc. All have a slightly off-set double image which is irritating to say the least. The surgery also decreased my night vision ability with the common side effect of 'starbursts' around any light source; headlights, street lights, traffic signals, etc. Over the years, the night vision has improved slightly as my eyes have healed. The double-vision though, has remained the same. When i told the lasik surgery clinic that i was having the double vision problems, they examined my eyes. They told me that the damage was not bad enough for it to warrant a corrective surgery and that i would have to live with the problem. All in all the experience was disappointing and painful. Had i to do it over again, i would certainly choose a different surgery clinic and would do much more research into the process before having it done.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037833
Almost immediately after having lasik surgery, i began to experience chronic dry-eye. I used several different types of otc and prescription eyedrops, such as restasis, thera-tears and systane, which i still use daily. One to two years following the surgery, the "floaters" in my left eye became more pronounced and bothersome; my right eye soon began to show the same symptoms. It became uncomfortable to watch tv, especially in a darkened room. I was often unable to clear my vision. I was constantly blinking and shaking my head to bring my eyes into focus. My vision would clear for a second or two, only to cloud up again almost immediately. This condition continued to worsen over the next 3 years, to the point where i have pronounced difficulty watching tv, watching movies or live shows such as plays or concerts, and driving at night. In addition to the problems with focus and floaters, i also have worsening problems with the "starburst" effects; when there are lights in my field of vision they seem to be flaring and amorphous. Even very small lights are like un-focused headlights past which i often cannot see. This is especially the case when the light source is at a distance of 6 feet or more.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037834
I had lasik surgery in 2007. For 4-5 months after the surgery, my eyes were very dry and i had to apply wetting drops several times a day. Also, my vision for the first few hours after i am up in the morning is not consistently clear. It is somewhat blurry and unfocused. This may be due to having gained a tolerance to the dryness. It gets better as the day progresses. I am assuming that the increased frequency of blinking is keeping my eyes wetter thus the improving conditions throughout the day. Now, more than a year later, my eyes always feel as if i have just woken up or been in a very dusty place. My colleagues often ask if i have an allergy or if i got enough sleep the night before.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037835
Dr. Performed lasik eye surgery on me. The date above is estimated. I would have to go investigate to get the actual date. My eyes were not too bad (20/50) and i was told i was a great candidate for the surgery. I was concerned about the halos, but was reassured that my chances were extremely slim. I had the surgery and have had bothersome halos ever since. At night, the glares are bad and if it rains on top of it, it makes driving more difficult. Several years later, i heard there is a surgery to correct the halos. I called dr. And asked the question and was told that it would cost substantial amount per eye to correct the situation.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037836
Since having lasik in 2005, i have had persistent severe dry eyes, trouble seeing at night, decreased depth perception, and sensitivity to sunlight. Also my vision has deteriorated to 20/50. Custom lasik, 2005 - not sure what day in - i received the lasik. Date of use: 2005.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037838
I had lasik surgery on both eyes, to correct nearsightedness. Since the surgery, i experience visual distortions, such as halos, starbursting, glare, difficulty seeing clearly in most lighting-situations, except outdoors during the daytime (natural sunlight). There is also some dry eye, which was present, to a lesser degree, before the surgery. After the surgery, other optometrists (not the doctors involved in the surgery) told me that i should never have been considered as a candidate for lasik, due to my large pupils and existing dry eyes. My tbu is somewhere around 3-4; prior to the surgery, i was having trouble wearing contact lenses because of this dryness; i was told that lasik could help, as i would not need cls after the surgery. Ironically, the only thing that restores part of my night vision is rigid gas permeable lenses, which have to be fit by an expert. They are extremely difficult to tolerate and expensive. It is also extremely difficult to find a doctor with the experience for fitting contact lenses for these types of problems. It is also possible that equipment -malfunction may have occurred, as well. I have decentered ablations. In any case, my large 8mm pupils/dry eyes practically guaranteed that i would have the above mentioned aberrations. Any possible contraindications were downplayed. Pre-op, i had a definite intolerance to rgps -and even soft lenses. Lasik induces tear-film problems that exacerbate contact-lens intolerance. After years of struggling with soft contact lenses, i would never have risked being rendered dependent on a type of lens that i myself knew -and was known by doctors- that i was unable to wear. I believe that the initial fda study suffered from "under-reporting". That is, most people do not even know of this form. I, myself, only happened upon it by mere chance. I guarantee that there are far more than the "140" people suffering from life-changing lasik-induced problems. Again, i'm not sure what is being looked for. "therapy" would be theratears eyedrops to treat dry eye, and endless fittings for speciality contact lens -macrolenses, etc. This has been ongoing since 2000.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037839
I had lasik surgery sometime in 2001. I am not sure of the exact date. I was extremely near-sighted prior to the surgery. My prescription was -9. 5 in my right eye and -9. 0 in my left eye. I started wearing glassed in approx. 5th grade, and contacts in 6th grade. I was very athletic my whole life and i hated to wear glasses, and so wore contacts all the time except for right before bedtime when i removed my contacts to go to bed -and i needed to wear my glasses literally, to find my way to the bed, the bathroom, etc. I was unable to see the clock by my bedside, unable to see a person's facial features a foot in front of me. I was very comfortable wearing contacts and they never ever bothered me one bit -beside the fact that you had to put them in and take them out everyday, buy solution, etc. So that is the background. I decided to get lasik. My father had successful rk in the late 1990's. Two of my sisters and a brother had successful lasik in the year or two prior to my lasik. I decided, why not me? it worked for them. I come from a family of 11 and we are practically all near-sighted to some degree, pretty severely in 4 or 5 of us. Upon my consult w/ the lasik doctor, he tested my cornea and said that it was probably thick enough to do the surgery, but wasn't sure it would be 100% successful, due to my severe prescription. I asked him if an unsuccessful surgery meant that i would not be able to see 20/20, but no worse off than my current condition at the time. He agreed and said, i would be no worse off. I verified that if the surgery did not work, i would still be able to wear contacts as opposed to glasses. He assured me i would. So basically, i figured, if the surgery was unsuccessful, all i would lose -or whatever it was at the time- and be right back to square one. Better than losing my eyesight. The surgery happened, and i definitely saw some improvement, i. E. I didn't have to wear my glasses/contacts to walk around the house or see the clock. However, i would consider the surgery unsuccessful. My night-vision was, and still is awful. And driving at night in the rain, forget it! i couldn't see the lines on the road, had a very severe depth perception problem, as in how close or far away is that car in front of me?, and the headlights on cars coming toward me were like big huge starbursts. I could not tell the difference sometimes between oncoming car headlights, street lights from above, and tail lights - at least these are red, so that clued me in. They all just looked like huge, huge circles of light. I had about 4 enhancements on my right eye in the next two years approx. , but to no avail. I actually developed astigmatism, my regular eye doctor told me, which i had not had previous to lasik. To make a long story short, i wear a contact in one eye, that eye is very dry, especially in air conditioning or direct heat - aka blowing from a car heater, and i don't see nearly as good as i did with my contacts pre-lasik. I wish i never would have gotten the surgery. I advise anyone w/ sight as bad as mine not to get lasik. Now, the shape of my eye -cornea- has changed so much from all of the enhancements that no contact will fit comfortably on my eye. I've tried about 5 or 6 different makes and models, even gave up at one point and wore glasses. I was furious and very sad, broke down in tears on many occasions. My eye doctor found this contact that works the best for me for now. As i said my eye is dry, but i will continue to wear it until i cannot stand it. There may come a time when glasses will outweigh dry eye. As for my left eye, i do not wear a contact. However, it is not 20/20. Can get along with it with the help of my contact-dependent right eye. I think it is actually far-sighted now -caused by the surgery. So there is really nothing i can do about that eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037840
Lasik surgery left me with serious night vision problems, halo effect and dry eyes.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037841
Had lasik surgery performed on both eyes. Serious "dry eye" has followed with pain in either or both eyes upon wakening. The original doctor indicated severe corneal erosion and prescribed various eye drops and salves along with contact lens bandages. These are not working. Tear duct plugs are in lower ducts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037843
Since having lasik several years ago, i have been experiencing episodes of iritis. I had never had these before. A medical work up was negative except for a positive hla-b27. Is this a side effect? is this something only those predisposed -say, being hla-b27 - get?
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037844
My eye sight is now ruined thanks to eye center. I have had multiple procedures on both eyes because my surgeon was careless during the initial lasik surgery. He performed too many surgeries on patients during too short of time that day - the nurse said it was the most they had ever scheduled, 21-, thus rushing and not cleaning up the epithelium under my lenses. As a result, the epithelium grew lifting the lenses and distorting the eye sight. They also contaminated the right eye with a foreign contaminate. I suspect the right eye sight was worse because the assistant failed to keep it adequately wet during the procedure. I could smell and hear the burning of the tissue and eventually the surgeon told him to apply more liquid during the initial surgery. I called them the next day and said that something was wrong because i couldn't see much out of my right eye, and my sight in the left eye which had been ideal had now become blurry. They tried to convince me that nothing was wrong and they attempted to make me feel as if i was being unreasonable. After arguing with the center's optometrist for one month, they finally agreed to re-do the right eye after 3 months from the original surgery. Unfortunately, when they performed the second surgery, they over-corrected the sight and now it is impossible for me to read with that eye, and is sometimes blurry at a distance. Although the left eye continues to be somewhat blurry, i am afraid to have them re-do it for fear they completely screw-up the sight in it as well. They also left a great deal of cells that float around in both eyes, the right having more than the left which is extremely irritating. Furthermore, i have severe halos in both eyes at night. Now i find it difficult to read - they said they would sell me reading glasses, one eye is blurry, the other eye was over-corrected. I can't drive at night without putting drops in my eyes, and suffer from eye strain -pain- and headaches. What can i do now that my eye sight is ruined? they never warned me about any of this! the fda should have been proactive at the inception of the lasik surgical procedure rather than reactive, which is always the norm. Now that the damage has been done to thousands of people why is the fda not allowing the victims to receive compensation from the doctors? an insurance fund should be set up. It is virtually impossible to sue the surgeons since no other surgeon will testify against their own, and patients are required to sign their life away to have the procedure performed without honestly knowing the risks. For the people who have already had the procedure, we need more help rather than just warnings! help us!!!!!.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037846
I developed salzmann's nodules in both eyes after having lasik surgery. I later had to have a second surgery to remove the worst of the nodules from my left eye. Some of them came back. I have them in both eyes and they run right along the periphery of the "flap" on each eye. My doctor tells me he has found no other cases where salzmann's was ever related to lasik although it's clear mine certainly is. In addition to the additional surgery, which was very painful, i have to use restasis drops every day. They are very expensive. It can be very uncomfortable particularly during the winter when my eyes get drier. At night my vision is very poor. Lights seem ot have halos or starbursts. Things look like they did when my vision was not corrected.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037847
I had lasik surgery on both of my eyes in 2008. I now suffer from blurred vision and have a halo effect during the evening hours. I am not pleased with my lasik surgery. If i can participate in any surveys, or supply any additional info, let me know.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037848
Lasik complications, requiring multiple attempts at correction with prolonged inflammation in recovery as a result of procedures. Lasik plus surgery centers.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037849
Far sighted vision change in left eye. Near sighted vision severely worsened in both eyes. Dry eyes, esp left eye. Cannot wear contacts because of dryness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037850
Lasik eye surgery with the following adverse effects: severe "halos" and sensitivity to light sources, reduced night vision and driving ability, extreme dry eyes, slight vision blurriness/nearsightedness not completely corrected.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037851
Lasik surgery gone wrong. Blurry vision, double vision, worst vision than before surgery. Pain, inflammation, redness, itchy, scratchy eye. Three months of pain. Twelve months of double vision and blurry vision.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037852
Lasik patient. I had 20/20 vision after the procedure but my vision has grown progressively worse since then. I require reading glasses for close which i understand is a natural aging result that can not be stopped. But now my distance vision is actually getting worse. In addition i have dry eyes that makes my vision less than acceptable. I'll soon resort back to glasses or contacts i expected my long term satisfaction to be more long term than 7 years.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037853
I continue to have problems with my night vision after lasik surgery. I still see starbursts and halos around lights that make everything look glary, which makes it hard to drive. Also, at times in the day i see some dark flutters at the top of my vision. When i told the doctor about it, but he said the flutters aren't related to the lasik, but i had never experienced this before. Also, he said the glare may be cause by the fact that one eye is corrected for close vision, and the other is corrected for distance. I had consented to this. I'm not sure these reasons are true.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037855
Lasik - simple myopia. Vision was 20/35 at first - then deteriorated. Dr did a follow-up enhancement with same results. Now i wear contacts with a 2. 25 correction. Dr was leader in field told me that he did nothing wrong and i was a "bad healer".
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037857
I had lasik surgery about 1 year ago. I opted for the laser, rather than the doctor, to make the cuts. For a couple of months after my surgery, i had very painful dry eyes. It was painful to open my eyes after a night's sleep. My doctor prescribed various eye drops, but nothing really worked until i received a prescription for restasis. In my opinion, restasis should have been prescribed on the day i received the lasik surgery. On a daily basis i still suffer from dry eyes, but nothing as painful as before the restasis. Now, i use otc bausch&lomb soothe drops when i wake up in the morning and throughout the day. Other than dry eyes i haven't had any other problems.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037858
Lasik performed. Cornea epithelium did not heal well, would not attach correction fluctuated for months with lots of glare problems at night, but went from about 20/5000 to 20/200.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037859
Lasik vision correction resulted in poor night vision and haloing.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037863
In late 1998 and early 1999, i had lasik vision correction od and os. It was noted, but never disclosed to me that my corneal thickness was "borderline" and that i had signs of keratoconus in one eye. Within a few years after surgery, my vision deteriorated in both eyes - i wear contact lenses to correct my vision and it is barely legal for me to drive. My eyes are cloudy most of the time, very red and at night, i can barely see to drive. I see halos around all lights, oncoming cars, brake lights, headlights, street lights. Watching the television is difficult too. Everything in my life has been affected by this surgery!!!! due to what has been diagnosed as post lasik ectasia by several doctors, my vision fluctuates, i have extremely dry eyes. I am partially disabled because i can not fulfill the duties of my jobs which include driving, seeing, shooting guns, spending hours on computers and keen visual acuity. I have had to take time off to see doctors from one state to another. I have to take time to rest my eyes every day. I have spent money on physicians -7 of them-, medical supplies. I have a box of data and files and all laboratory tests and data and am willing to travel anywhere to bring them to you or send them to you. Please contact me immediately.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1039142
We didn't wish to get involved with the on-line form, so we are writing a letter instead. We are very interested in receiving info from your recent hearings dealing with lasik surgery. My wife is a victim of this horrible procedure. Six years ago, she underwent lasik surgery on both eyes. The results were no help with vision and ongoing pian in her right eye. We consulted with the top ophthalmologists regarding treatment for this excruciating pain with no help. Basically, the answers were "we don't know what to do to relieve your condition. " we ended up going to another state to see a dr, who we located thru the internet. His diagnosis was basically dry eyes and unequal distribution of tears over the surface of the eye. He recommended resurfacing the eye with placenta material at a cost for his fee and outpatient fee at the hosp. This procedure had very positive results and alleviated the pain, but it didn't last. The pain came back in 3-4 months. We are now back to square one with intense pain. Please send us minutes of these hearings or any reports derived form the hearings as prescribed by the freedom of info act. Thank you.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1212031
I had lasik eye surgery on both eyes. I was at -3 diopter with slight astigmatism in both eyes before the surgery. I was near sighted. Before the surgery and during the surgery, i was not given any instruction on what to do with my eyes. The night before i read in the prep booklet that i was supposed to focus on the light. Following this direction i focused on the light during the surgery for my right eye, but when it came to my left eye, i had trouble focusing on the light, so i moved my eye to re-focus, and after the second time of doing this, the doctor finally directed me to stop moving my eye. Anyway, after the surgery, my left eye felt strange right away, like it was irritated more than the right eye and the vision wasn't as good. With the post-op care i told my doctors that my left eye was always irritated, but they couldn't tell what was wrong with it, only agree that it appeared to be more irritated than the right. It's a year and a half later and my left eye still feels the same pretty much all the time, like there's something in the eye, like i'm wearing a contact that should have been taken out a long time ago. The vision out of that eye is somewhat fuzzy as well. My doctors say that the only problem they see is that my eyes are drier now; about 6 second tear break-up time. They say that the irritation could be caused by sensitivity to dust, wind, particles in the air that wouldn't have irritated the eye before with a healthy tear film, but now do, because of the dry eyes. And this doesn't explain why the left eye feels so irritated and has poorer vision than the right, even though the dry eye is the same in both. When first dealing with this condition, i believe i had ptsd because i had suicidal ideations and had serious plans to kill myself of three separate occasions. I've had depression before, but never suicidal thoughts. This was shocking and a horrible experience. I am grateful to vision surgery rehab. I talked on the phone and email and shared my fears and my emotional distress and i finally came out of my suicidal ideation phase. Dr was helpful in giving me eye health info. Lasik center.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1211624
Following a prk procedure, the doctor reported observing a "central island" in the patient's left eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1222366
Reporter states that since his lasik eye surgery in 2005 that he has not been able to clearly see items that are less than 10 feet away. Repoter states that during the consultations with the referenced md, he was told that people with eye worse that his had been corrected. Repoter states that since the surgery he consulted with another md and states, he was told that he was not a good candidate for lasik surgery due to his age and the poor condition of his eyes. Reporter states that he does not know if the problem he is now having is with his eyes is due to poor surgical technique by the md, if there was a malfunction with the laser or if it was just because he was a poor candidate for the procedure.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1190308
Event Description: Pt has claimed in a law suit that his vision has been damaged due to the lasik surgery, he had in early 2007. The pt is claiming that the doctor who performed the surgery did not check his eyes or examine him before the surgery. The pt claims that the doctor was relying solely on the exam done by the person the pt originally had seen. The surgery was performed, and the pt claims to have had severe pain and bleeding in the left eye. The pt states that the pain did not stop after the surgery and he was still in intense pain at the 24 hour exam and was told, at this time, that he had "sands of sahara" aka dlk (diffuse lamellar keratitis). He was given prescriptions and then was seen by the doctor who had performed the surgery. The pt was told that the "sands of sahara" would "wear off". After seven months, the pt had an enhancement procedure (six months later). The pt is claiming that after this enhancement procedure, his eyes were worse. The pt is now under the care of another doctor. Manufacturer Narrative: In 2008, nidek inc was notified that pt injury had occurred in early 2007. This notification came via the injured patients attorney. Nidek did not receive any prior notification of any pt injury. Once we received, the notification of pt injury, we began an investigation and requested pt data. The physician's office was cooperative and sent the info to us in a timely manner. However, they were unable to supply us with the serial number of the device used during this patients surgery. The summary of the pt data is included in attachment a. According to the pt data, this pt had undergone lasik treatment in 2002 by another physician, there are no medical records to support this. There are no records past(seven months later). It is our understanding that the pt then went to another physician for care. Based on the pt data received, it is determined that the cause of the pt injury is inconclusive. The pt data refers to problems with dlk (diffuse lamellar keratitis), and no device malfunction was reported.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1184266
Manufacturer Narrative: A field service engineer (fse) performed a scheduled pm in 2008, and the laser system met specifications and performed as intended. A clinical development specialist (cds) provided surgery support two months later, to assess the physician's laser settings, surgical technique's and sterility process in order to identify a potential root cause for dlk. The laser and sterilizer were evaluated and found to be within specification. The most likely root cause was due to the doctor adjusting the surgical settings that increased the opaque bubble layer (obl), causing sticky lifts. In order to help the bubbles escape, the surgeon used the end of a disposable cannula to massage the obl, which in turn caused the dlk. Upon departure, the cds adjusted the settings for the surgeon and lowered the energy. The dlk has been resolved. Opaque bubble layer, sticky lifts, unlabeled. Event Description: The intralase fs laser was used to create a bilateral corneal flap(s) for lasik surgery in 2008. One day postoperatively the following day, the patient presented with stage 1+ bilateral diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed ou the next day, a second flap lift and rinse on the left (os) eye four days later. Due to stage 2 dlk. The patient was prescribed topical steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative bcva is 20/20 ou. The patent responded to treatment and dlk has resolved. The association between the event and the device is unknown.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1114175
A small, wedge shaped, transected partial flap was created during the pass of the microkeratome. The transected wedge was hydrated with balanced salt solution, and antibiotic and replaced.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1074456
Event Description: In late 2007, nidek inc received a call from hospital, reporting 2 free flaps on two patients while using the nidek mk-2000, reporter stated that no patient injury occurred, however, they requested an inspection and service to be done on the keratome. Nidek inc. Completed the call log and incident report (documenting that no patient injury occurred) and arranged to have the keratome shipped in for service. Manufacturer Narrative: In late 2007 nidek inc. Was originally informed of the two free flaps on two different patients, we were told by the facility that there was no patient injury. Nidek opened incident report. Nidek received the unit in for repair and found damage to the handpiece that may have resulted in the "hinge" size too small, which could result in a free flap. All other findings/problems on the mk were from normal wear and tear. The unit was repaired and returned to the customer. Based on the service report and the claim that no injury occurred, nidek closed this incident report. In early 2008, we received another call from the same facility stating they had another incident using their second mk-2000. The caller did not have any details at the time. Nidek opened incident report and coordinated to have this unit sent in for inspection. Due to the fact that nidek received two calls within a short period of time, claiming similar issues with two different keratomes, we decided to reopen the original incident report and started investigating. Nidek made repeated attempts at contacting the facility and was told that these matters were being handled by the risk management department. Nidek finally received all the documentation regarding these "incidents" from hospital risk management, six months after the original incident. At this time, we were made aware that one of the patients required surgical intervention to prevent impairment to vision and/or cornea. The patient required 4 sutures, after the laser was completed to hold the "free flap" in place. We requested further patient data and it was received on 07/08/08. This information states that the patient is healing as expected with no further complications. In conclusion, nidek inc. Has determined this to be user error that caused damage to the microkeratome which resulted in a free flap.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1069410
The pt developed diffuse lamellar keratitis in the left eye after undergoing a lasik procedure. The flap was lifted and irrigated and the pt was treated with topical steroids.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037459
The intralase fs laser was used to create corneal flap(s) for lasik surgery (exact date(s) not provided), the surgeon is seeing approx 10% of patients' with diffuse lamellar keratitis (dlk) post-operatively. The degree of dlk varies from trace to 3+ through 4+ including several cases of central toxic keratopathy (ctk). A couple of pts required flap lift and rinse due to stage 3+ and 4+ dlk. The surgeon confirms that all cases have resolved with steroidal treatment with no significant loss of vision. No pt info was provided, as the site did not keep track of all pts that presented with dlk, once it had cleared.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1032770
Manufacturer Narrative: The following is a description of the event as relayed to nidek inc both verbally and on the mk complaint form by loden vision center: in 2008, the physician was creating a temporal incision on the pt's mayopic right eye, with the mk-2000 hand piece, 180um blade holder and the 9. 0mm suction ring combination. The microkeratome was placed on the cornea, good suction obtained and noted. Keratome "bucked" and stopped. Physician stated "keratome appeared to have jammed into the lid speculum. " the microkeratome was removed from the pt's eye and reinspected, proper assembly confirmed, wedge in place and full test run performed. "all appeared normal. " suction ring was placed back on the cornea and suction acquired. Microkeratome advanced and immediately stopped when suction was lost. Microkeratome was removed from the pt's eye. "anterior chamber noted to be flat, but anatomically intact. " "anterior chamber filled with viscoat as large opening temporaily where keratome entered the eye. " a bandage contact lens was placed and pt was given vigamox. Patient was transported to the operating room and the cornea was sutured. The following month, dr's handpiece and blade holder were received at nidek inc. For inspection. Prior to the inspection, it was found that this microkeratome had not been serviced for 3 years. During the inspection, the technician found the hand piece ot be out of specification and the blade holder had damage on the surface. It is nidek's conclusion that the problems found with the microkeratome did not attribute to the incident of the perforated cornea. It has been determined as user error. Event Description: On 03/31/08, nidek inc rec'd report of an adverse event from facility. Rep reported that while using the mk-2000, the patients anterior chamber of the right cornea was perforated, on the temporal side of the eye. Rep stated, that the perforation was not near the visual axis and that the pt's vision was not affected. The pt required 3 sutures on the cornea. Dr loden stated that during the procedure the mk-2000 (keratome) may have come in contact with the lid speculum while creating the corneal flap causing the keratome to "dive" into the eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1157865
Image from lasik surgery, dr. The intralase flap cutter, and the alcon 6000 laser platform. When are you going to do something about lasik surgery? how many more people are going to be hurt?
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1147487
Event Description: The intralase fs laser was used to create corneal flap(s) for lasik surgery (exact date(s) not provided). Pt's flaps were thicker than expected with opaque bubble layer (obl) at the pocket which resulted in sticky lifts. Post-operatively pts presented with diffuse lamellar keratitis (dlk). Stage of dlk varies in degree from stage 1-3 with 3 -5 pts requiring a flap lift and rinse. Pt info was requested from the user facility, however, no pt info was provided. The surgeon confirms that all cases have resolved with steroidal treatment and no loss of vision. Manufacturer Narrative: A clinical development specialist (cds) has been in contact with the physician since 07/30/2008 obtaining pt f/u status. According to the physician, the root cause of the reported event was narrowed down to the gloves that were being use during surgery. Since the surgeon discontinued the use of the gloves, there have been no further cases of dlk. In 2008, a field svc engineer (fse) visited the site and performed a quarterly preventive maintenance (pm). Device performed according to specs. Additional: other, opaque bubble layer, thick flaps, sticky lifts.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1081629
Manufacturer Narrative: A clinical development specialist (cds) has been in contact with the physician since 2008 obtaining patient follow-up status. Dlk and spk has resolved. On the day before, an intralase field service engineer (fse) visited the site and performed a field validation. No problems directly related to dlk was found with the system. Perform pm. Other, superficial punctate keratitis (spk); flap striae; epithelial scraped. Event Description: The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2008. One day postoperatively on the next day, the patient presented with bilateral diffuse lamellar keratitis (dlk). On two days later, a flap lift and rinse was performed for both (ou) eyes. Two weeks postoperatively, patient presented with superficial punctate keratitis (spk) on the right (od) eye with folds on the left (os) eye, flap was lifted and stretched with epithelial scrape. The patient was prescribed topical steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative bcva as of one and a half months later, in the right (od) eye was 20/20 and 20/25 left (os) eye. The patient is responding to treatment and dlk and spk has resolved. The association between the event and the device is unknown.