Post-LASIK Ectasia Reported to the FDA

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3966350

I had LASIK eye surgery in [redacted by FDA] 2006 by an extremely reputable doctor. A few months later, vision in right eye rapidly deteriorated. It wasn't until 2 years after the procedure that I was diagnosed with post LASIK ectasia. It was another year before the symptoms appeared in my left eye. Since then I have spent much time, energy and money attempting to save what vision I have left and avoid having cornea transplants.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3591097

I had LASIK and an additional LASIK enhancement back in 2001 in [redacted by FDA]. Immediately afterwards (within a few weeks), my eye sight reversed back to being nearsighted again, and progressively got worse. I had follow ups at the clinic for a year. My initial symptoms included very dry eyes (almost glued like in mornings), and night hallow/starry effect. A month prior to surgery, the doctor told me that I had thinner corneas (less than 500 micron) and suggested PRK. However, on that day of the surgery, he took three point corneal thickness measurements with ultra sound device and declared I am ok for LASIK. My flap was lifted and surgery performed. I still don't understand how a three point reading by hand was better than the thickness measuring machine. My eye sight was ok 20/20 for two weeks, then progressively deteriorated. After three months, he performed an enhancement procedure as well, and made it worse. During the course, I tried soft lenses, glasses, until my vision could not be further corrected with glasses. Then in 2007 I saw an optometrist who prescribed RGP hard lenses for correction, and diagnosed me with ectasia/keratoconus. Hard lenses were uncomfortable on my already damaged corneas, I tolerated with pain next few years going from pair after pair. I even went overseas to look for options and tested custom fit hard RGP lenses, still struggled with fitting and irritation. It impacted my work as well, I became very shy at meeting people and holding business conversations eye to eye. I was finally referred to [redacted by FDA] for sight (what a miracle), here I was fitted over a six month period with a custom scleral device lens. It was the best thing since sliced bread! I longer had dry eyes, and my vision improved to 20/20 in both eyes. When I look back what I know now I never would have gone for LASIK with my thin corneas, and the surgeon never suggested that I was at risk and should not go for surgery. The evidences was in the Orbscans showing clearly thinning corneas (red zones/circles). I am lucky to still have my sight and able to wear scleral devices from [redacted by FDA].

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3553965

I had LASIK in 2000 to correct issues related to general nearsightedness. The surgery was performed at [redacted by FDA] location. I had the initial LASIK surgery and then when my situation worsened had what is known as an "enhancement" which was another surgery at the same location 6 months later. In the past 13 years I have been told that I either have keratoconus or corneal ectasia. After reading online and seeing info, my post LASIK life-altering vision deterioration was a direct result of surgery and not a pre-existing issue, such as keratoconus.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=3122039

An optometrist reported a case of 'suspect cornea ectasia', noted 6 years post bilateral lasik procedure. Reporter stated that the patient has been referred to another physician for further evaluation and confirmation of diagnosis. Report received noted that the patient expressed dryness, bilaterally, and decreased vision at distance and near. Patient mentioned having gone back to occasional wear of contacts and glasses, and that he was interested in an enhancement. Additional information has been requested. This report references the patient's left eye.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=3029137

The clinic reported that a laser vision correction patient presented approximately 6 years following a lasik procedure with corneal ectasia in each eye. The patient was referred to a specialist for evaluation for corneal cross linking. The patient's uncorrected visual acuity is 20/40 right eye and 20/25 left eye.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2916413

Lasik performed by dr. (b)(6). I have post-lasik ectasia and my insurance company will not cover the procedure recommended intacs, keratoplasty, and uv collagen treatment by my doctor, dr. (b)(6). Numerous visits to ophthalmologist, had to spend about (b)(6) on procedure so far. Uv collagen crosslinking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2881566

A technician reported that a pt who had undergone LASIK, came in to the clinic 17 months post LASIK, and reported blurry vision. The pt was diagnosed with suspicious steepening of both corneas, more so in the left. This report concerns the left eye. The examination findings were explanted to the pt, and the pt will return to the clinic in three to six months to be observed for progression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2820890

[redacted by FDA] performed LASIK surgery on me knowing that I have first degree relative with keratokonus. I had 10 diopters of myopia and was treated with LASIK eye surgery - not prk. After the fact I have learned that I should not have been a candidate. I am afraid I will develop, because of [redacted by FDA] doing LASIK on me without disclosing complications of being a high myope, [redacted by FDA] and first degree relative with keratoconus, ectasia due to having LASIK that I may not have otherwise been at risk for.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2802853

The clinic reported that a laser vision correction patient presented post operatively with corneal ectasia and irregular astigmatism in the left eye which caused a rapid decrease in vision. The patient's lasik treatment was performed about 5 years earlier. The surgeon has sent the patient information to a specialist to determine if the patient is a candidate for crosslinking. The patients uncorrected visual acuity in the left eye is 20/400 and the best corrected visual acuity is 20/25.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2732348

Had LASIK performed on both eyes in 2001. Recently, vision has deteriorated in right eye. Not knowing what the problem was, investigated having another LASIK procedure and was told that I have a "coning" of the cornea. Described to me as keratoconus, but this I understand, starts during childhood. Actually have post LASIK ectasia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2498053

Had LASIK done in 2000. In 2012, diagnosed with corneal keratoconus ectasia. Which now I will now be fitted for a hard lens that might stabilize the problem. But eventually will lead to a corneal transplant.

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=2389899

Center director reports, via a voluntary Medwatch form, a case of postoperative keratoconus or ectasia, after LASIK surgery. Follow up info noted that only the left eye was affected. Post operative findings show pt experienced irregular astigmatism, and loss of bcva. Pt also reported blurry vision for the past two years. This report references the pt's right eye. Left eye is reported under mfr report# 1061857-2011-00012. Add'l info from user facility: possible keratoconus or ectasia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2018815

Manufacturer Narrative: Ectasia is a bulging of the cornea. Ectasia is also called iatrogenic keratoconus, post-lasik keratoconus or secondary keratoconus because it is basically a surgically induced version of the naturally occurring disease keratoconus. Possible causes to lasik-related complication known as ectasia, iatrogenic keratoconus, post-lasik keratoconus or secondary keratoconus are: pts who have current signs, early signs or clinical indications of keratoconus or any other corneal pathologies. Pts with glaucoma and/or ocular hypertension (iop>21mmhg). Residual stromal thickness less than 250 microns after lasik surgery. Corneal flap complications such as irregular flaps. Unreliable topography due to contact lens warpage and or not having contact lenses out long enough prior to initial exam and/or surgery. We provided necessary info and training to surgical doctors who use ec-5000 to prevent adverse events. The info includes contraindication, precaution, and pt selection. Based on the info presented, nidek inc is unable to determine the root cause of this injury. If further info is received, we will submit a f/u.

Event Description: [redacted by FDA]. The report [redacted by FDA] stated a pt had lasik procedure with ec-5000 excimer laser in 2000. Per the maude event report: lasik procedure performed in 2000. In 2006, eyes went "bad" due to thin corneas. Loss of corrected sight. Diagnosed with post-lasik keratoconus or as the pt stated "lasik induced thinning of corneas keratoconus". Prescribed gas permeable contact lenses that are very uncomfortable to wear due to surgery. Pt sought out medical intervention. Medical intervention is currently required for the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2359722

The clinic reported that a LASIK pt was diagnosed with corneal ectasia in the right eye approx 2 years following their LASIK treatment. The post-op exam revealed corneal steepening and a loss of uncorrected visual acuity. There has been no loss of best corrected visual acuity. The latest pentacam examination performed approx three months following the initial diagnoses shows no progression of the ectasia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3140763

The clinic reported that a laser vision correction patient presented with corneal ectasia in both eyes approximately 4 years following a laser enhancement treatment. The patient's uncorrected visual acuity is 20/40 in the right eye and 20/30 in the left eye. The best corrected visual acuity is 20/20 in each eye. The patient was referred to a specialist for follow-up care and possible cross linking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3231396

Lasik surgery both eyes in 2000. Started worsening vision in 2005. Now diagnosed with ectasia, both eyes, requiring corneal transplant, may lead to blindness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3264275

A clinical director reported that a pt who had undergone lasik nearly eight years ago, presented with decreased vision in the left eye for the past two years, and poor night vision. The pt was examined and diagnosed with irregular astigmatism and corneal ectasia. The current surgeon is consulting with another surgeon to determine whether corneal cross-linking treatment may benefit this pt. They do not have info indicating specifically which laser this pt was treated on, but do not believe it was a laser manufactured by this company. No additional pt info is available.

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=2315699

[Reported by manufacturer, AMO, VISX laser] The clinic reported that a patient who underwent an uneventful laser vision correction on [redacted] 2001 was evaluated for an enhancement on [redacted] 2011 and was diagnosed with keratectasia with loss of best corrected visual acuity. The patient's visual acuity in the right eye was 20/40 and in the left eye was 20/50. The patient was fit with a gas permeable contact lens.

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=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=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=2050286

I was diagnosed with keratoconus and deemed to not be a candidate for LASIK. Several months later I went to the same office to inquire about PRK. They tested and decided I was a candidate for LASIK. I had the surgery done in the right eye. My vision now is by far worse than it was initially. They are now talking about cornea transplant. I won't go back to them. F/u and fitted for contact lens. Lens will not stay in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2021698

Serious side effects after LASIK. Dr. [redacted by FDA]. He was too cocky and took too much of my cornea. Other doctors say that he shouldn't have done it and offered other treatments instead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2025234

In 2002, Dr. [redacted by FDA] performed LASIK eye surgery on both of my eyes. It was necessary to perform an enhancement in 2005. On [redacted by FDA] 2011, I had an eye exam with Dr. [redacted by FDA] who stated I now had an unstable cornea which was the reason I had trouble with my eyes focusing enough to perform my job as a customer service rep. As a result I was let go, told I could not perform the duties necessary and didn't' fit in because of my inaccuracy. I told my immediate supervisor that I was having trouble viewing the computer screen and had an eye doctor appointment scheduled. I was still let go. On [redacted by FDA] 2011, Dr. [redacted by FDA] informed me that I had an unstable cornea which was the reason for my inability to focus my eyes especially later in the day when my eyes were tired. He told me he offered ultraviolet treatments which would strengthen my cornea and improve my vision. He told me it was not yet FDA approved but, would be in six months. His fee was [redacted by FDA] per eye. I asked if my prior surgeries were a contributing factor and he denied any correlation. I have since researched and have found that there is a direct correlation between LASIK eye surgery and corneal ectasia or unstable cornea. Dr. [redacted by FDA] did not inform me that this was a side effect as a result of LASIK surgery. Nowhere in the previous documentation from Dr. [redacted by FDA] does he mention that corneal ectasia can occur as a result of LASIK surgery. I should not have to pay a physician more money to correct what he may have originally caused. I feel those doctors that hid this info from their patients should be required to fix these errors that they themselves created. They should not be allowed further monetary advancement due to their negligence. Ultraviolet therapy was advised by Dr. [redacted by FDA] as the only solution to an unstable cornea. I don't want further eye problems nor should Dr. [redacted by FDA] benefit monetarily for previous negligence.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2028363

I had lasik in 1999 and in 2005, I had keratoconus. I feel that I was not a good candidate for this procedure. To correct this, I had to undergo a corneal transplant in 2007.

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=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] MD. 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=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=1908973

I had LASIK eye surgery on [redacted] 2004, at [redacted] clinic hospital. Dr [redacted] did the surgery on both eyes. I was treated for 1 year free of charge. Now, my ophthalmologist says I have corneal ecstasia in my right eye. The vision in that eye is blurry and glasses don’t help. My doctor says I will need to be fitted with a special contact lens.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1898150

Bilateral lasik surgery in 2001. Developed severe ectasia in 2006. Some degree of correction had with contact lenses although, the adverse effects of lasik are still progressing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1852887

Seven yrs after having lasik eye surgery, I now have corneal ectasia. I was [redacted] at the time of my surgery and I passed through all prescreening tests with no problems. My vision was great for about 6 yrs and it has steadily got worse over the past yr and a half. I don't really know what my vision is now but I'm unable to function well without my glasses and they don't help much. I've recently got gas permeable hard contacts and it has corrected my vision to 20/20. I do have concerns that either the LASIK was not done correctly or the "1 in 2000 chance" of something going wrong with the procedure is a false statement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1845003

I had lasik in [redacted] 2002, I had to have one revision. Now I have been diagnosed with a form of keratoconus caused by the surgery. My eye sight is changing for the worse every 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1781584

I had lasik surgery and after 1 year I developed ectasia after lasik. My eyes have changed dramatically since the lasik surgery. I require trifocals, and my vision is much worse than it was before i had lasik surgery. I have a different prescription in both eyes. Eventually, if my eyes continue to get worse, I could be left with minimum ability to see at all.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1666368

Developed ectasia keratoconus from lasik. Was not diagnosed until 3 yrs after surgery. One eye cannot be corrected better than 20/80 and that is with horrible vision, never clear, always fuzzy. Tried piggy back contacts lens, hard lenses with soft skirt. Could not read with these lenses in. Can no longer bear wearing these. Presently using a soft contact lens, although vision not clear. Struggling to read. Nightmare to drive at night. One light multiplies at a distance, cannot judge distance. There doesn't seem to be anything you can do! my daughter had the same surgery and has the same condition. She had a corneal transplant (b) (6) 2008 and sees worse now than before the transplant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1657876

I had LASIK procedure performed on (b) (6) 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=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=1344445

Lasik was done back in 2000. Developed severe visual disturbances in left eye, did not get properly diagnosed until 2007. Besides the horrible dry-eye; i have post-lasik ectasia, one of the most feared complications of lasik. This complication also can take years to show up. And with eye doctors lack of knowledge on the subject i was misdiagnosed for years!! because of lasik i am legally blind in my left eye. The only way to correct my vision in this eye is with hard contacts and then eventually will need a cornea transplant. This still will not correct the problem. Should not have to think about needing a cornea transplant at this age. Thank god my right eye was spared any permanent damage. It is horrible the way people are lead to believe that this is a harmless vision corrective measure. Doctors need to be more upfront with the serious risks that are involved. Seeing that it's not covered by insurance, i feel like it's just a money maker for these doctors. Yes there are some legit and honest doctors out there. However, there are quite a few that will do lasik on anyone who walks through their doors. Please help get better information out there to people in regard to lasik.

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=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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1392621

A review of the maude database revealed the following voluntary report from a pt "I underwent custom vue lasik procedure in 2005. After the surgery, I have experienced the following problems in my left eye: approx 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-. " pt reports being treated with the following medications: zymar, tobradex drops, tobradex ointment, liquid tears, lotemax, neomycin, polymixin b sulfates and dexamethosone ophthalmic suspension usp.

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=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-.

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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.

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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.

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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.

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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.

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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=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.

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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.

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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.

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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.

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I had lasik surgery in 2002. In 2006, i began noticing blurriness in both eyes. In two months later, i was diagnosed with post-lasik keratoconus -ectasia-. At the time of the surgery, i was not informed of a potential problem such as this. The surgeon merely made a comment to the effect of "your corneas seem a little thin, but i think the surgery should be okay. " prior to the surgery, i was -6. 00 in the right eye and -8. 00 in the left. I am presently at -6. 00 in the left eye, and over -9. 00 in the right eye. Eventually, i may need to attempt a corneal transplant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=377083

Nidek inc learned of the following event from an article published in the american journal of ophthalmology 2001; 132 (6):920-921. A pt was to undergo a lasik procedure on the eye due to compound myopic astigmatism. Following the nidek mk-2000 microkeratome pass, it was reported by the primary surgeon that the conreal flap was observed to be an "irregular, jagged flap". The lasik procedure was aborted, and the primary keratotomy flap was immediately repositioned. At 11 days postoperative the "bscva" was 20/100 with a manifest refraction of -20. 0 +5. 50 x 120. Slit lamp examination demonstrated a nasal hinged primary keratotomy flap at 90% depth through the corneal stroma with evidence of central ectasia. At one month postoperative, the "bscva" was 20/100 with a manifest refraction of -30. 0 +8. 50 x 100. The ectasia had progressed, and the pt underwent fitting for a rigid gas permeable contact lens and was being considered for possible penetrating keratoplasty. Nidek, inc has contacted the ophthalmologists that authored the ajo article to obtain further info on the device and pt. As of the date of this report, no response has been received from the authors. No device serial number has been obtained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=334946

Pt indicated that lasik procedure resulted in ectasia after stronal base was reduced below 250 microns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=334801

Information was received that "penetration" of anterior chamber, "occurred during refractive surgery performed in 1999. It was further reported that the patient experience "damage" to endothelial cells, corneal "ectasia", "loss" of visual acuity, monocular diplopia and halos. A review of the company's records showed no record of the event being reported by either the surgeon or the user facility. The event information was received on 4/30/2001. the company has no record of the hansatome being returned for the reported event. The company also has no record of the reported event being reported by either the surgeon or the user facility.

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Rptr underwent lasik eye surgery - but was really not a good candidate having very high myopia and high astigmatism. The dr used the summit laser that had fda approval for leaving a 250 rule of residual stromal base. Rptr's rx was 71. 00 and -12. 00. The dr did an enhancement surgery knowing he would take rptr below this rule - and ectasia resulted. He also double-carded the laser which rptr is not sure meets with it's requirements. But he was aware of the risks of a too thin cornea. Rptr now needs a corneal transplant, cannot drive, work and use 3 contact lenses to see 20/40, 20/30 and rptr wears bifocals to see near.