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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 Date 01/08/1999
Event Type  Injury  
Event Description

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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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1037788
Report NumberMW5006574
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Date Received: 05/01/2008 Patient Sequence Number: 1