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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
Lot Number UNK LASIK
Device Problem Insufficient Information (3190)
Patient Problem Loss of Vision (2139)
Event Date 12/30/1999
Event Type  Injury  
Event Description

(b)(6) lasik surgery in (b)(6). Corrected to 20/20 right after surgery but gradually declined to about -1 diopters within the first yr. Currently -5. 5 in left eye and -3. 5 in right eye. Have had continual visual shifting with frequent prescription changes due to "post lasik corneal instability. " have had to be fitted with hybrid contact lenses. Referred to neuroopthomologist due to frequent changes in vision. No evidence currently of neurological etiology. All structural post lasik.

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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2143863
MDR Text Key2120444
Report NumberMW5021141
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 06/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device LOT NumberUNK LASIK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 06/23/2011 Patient Sequence Number: 1