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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 06/29/2011
Event Type  Injury  
Event Description

Had lasik surgery in 1997 and 1998 from (b)(6) eye center in (b)(6). I was very near sighted (b)(6). I needed two enhancements for a total of three surgeries. I have experienced dry eyes and gradual near sightedness. My optometrist has diagnosed me with ectasia as a result of my surgery.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2153237
MDR Text Key14966031
Report NumberMW5021233
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 06/30/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2011
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

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