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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Event Type  Other  
Event Description

This letter addresses my concern about the safety of lasik surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on lasik, i decided not to do the surgery. I believe lasik surgery is not consistent with the ophthalmologist's hypocritic oath of "first do no harm. " statistics on complications could easily be manipulated by surgeons and i don't think their reporting of complications can be relied upon. I think a few points are more valid: it was reported in the last year in the literature that lasik surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the lasik flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When i have explained this fact to hundreds of patients who were considering lasik, everyone stated that it is enough reason not to do the surgery. I explained to them that it's as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won't do the surgery. When i have seen patients that have had lasik surgery with other doctors, none of them were aware of this fact. We are playing russian roulette with these patients, hoping statistically that they won't be hit in the eye. We are also playing this roulette game hoping beyond all hope that they don't get infection, but we all know infections happen. I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are lasik surgeons, why aren't we more concerned about the damaging effects of lasik which causes dry eye and damaged corneal nerves. They elected not to answer the question. I think we have a panel already in this country that is ideal to give you the answer to the problems with lasik. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don't do this surgery and ask them why they don't do it. I have seen other examples of where the fda allows higher risk manipulations of the eyes when it clearly is against the patients' interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence. The three examples cited in the letter, i. E. , lasik surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a "wow" factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over "first do not harm".

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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1064755
Report NumberMW5007415
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No