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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 05/01/2001
Event Type  Injury  
Event Description

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.

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Type of DeviceLASIK
MDR Report Key1059460
Report NumberMW5007249
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 06/10/2008 Patient Sequence Number: 1