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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 03/01/2010
Event Type  Injury  
Event Description

Six years post-lasik, my wife was diagnosed with corneal ectasia after developing severe headaches, severe dry eye, and severe eye pain and vision problems (distortions, halo, extreme photosensitivity, shadows, ghostings, loss of night vision, and more); she lost her job as an it professional because she was unable to perform duties as a result of these issues, developed severe depression and anxiety and was suicidal; she has not recovered emotionally from the catastrophic outcome of this procedure.

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key6311002
Report NumberMW5067723
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 02/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2017
Is This An Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/07/2017 Patient Sequence Number: 1
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