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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NONE

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Event Date 02/17/1999
Event Type  Injury  
Event Description

I had lasik performed in 1999 and an enhancement in 2000. It was performed by dr at hospital. I have had a disabling glare and vision problems ever since. I know that i filled out a disclaimer for the surgery. What upsets me is the fact that pupil size and dry eye were never discussed, and the possibility that vision indoors and in dimly lit situations would be effected. This information was not in the disclaimer. I now use alphagan p off label, which is also a questionable practice. I did not know that the fda was the proper forum to file a complaint until recently.

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Type of DeviceNONE
MDR Report Key1275406
Report NumberMW5009387
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/18/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No

Date Received: 12/18/2008 Patient Sequence Number: 1