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-.
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=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=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.
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=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=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=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=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=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=1035279
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.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=324715
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.