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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Date 03/01/2006
Event Type  Injury  
Event Description

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.

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Type of DeviceLASIK
MDR Report Key1202339
Report NumberMW5008646
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/15/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2008
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: 10/15/2008 Patient Sequence Number: 1