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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 07/01/2006
Event Type  Injury  
Event Description

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.

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Type of DeviceLASIK
MDR Report Key1052885
Report NumberMW5007047
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/27/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2008
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

Date Received: 05/27/2008 Patient Sequence Number: 1