Reports Filed with the FDA

Whenever a medical device malfunctions, the doctor using the device is required to file a report with the FDA. Most LASIK surgeons never do this. As a result, there are no firm records of the number of adverse LASIK events in the United States. Many reports are filed by the patients themselves. Below are some recent reports, with links back to the FDA's MAUDE database.

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.

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.

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.

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.

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.

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.

Manufacturer Narrative: 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.

Event Description: 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.

Manufacturer Narrative: 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.

Event Description: 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.

WAVEFRONT LASIK SURGERY: 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.

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.

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.

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.

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.

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.

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!.

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.

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.

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.

Event Description 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.

Manufacturer Narrative 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.