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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
Device Problem Insufficient Information (3190)
Patient Problem Visual Impairment (2138)
Event Date 10/10/2001
Event Type  Injury  
Event Description

Lasik surgery that caused decreased night vision and decreased night depth perception. Read that enlarged pupils may be cause. I was never advised this could be a problem with lasik surgery although eye doctors had told me i have enlarged pupils. Eye doctors also advised that i was a good candidate for lasik surgery and my vision since is 20/15 and has maybe changed to 20/20. My vision before was 20/450.

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Brand NameNA
Type of DeviceLASIK
MDR Report Key2048252
MDR Text Key1864983
Report NumberMW5020179
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 04/05/2011 Patient Sequence Number: 1