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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY

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LASIK EYE SURGERY Back to Search Results
Event Type  Injury  
Event Description

Reporter states that since his lasik eye surgery in 2005 that he has not been able to clearly see items that are less than 10 feet away. Repoter states that during the consultations with the referenced md, he was told that people with eye worse that his had been corrected. Repoter states that since the surgery he consulted with another md and states, he was told that he was not a good candidate for lasik surgery due to his age and the poor condition of his eyes. Reporter states that he does not know if the problem he is now having is with his eyes is due to poor surgical technique by the md, if there was a malfunction with the laser or if it was just because he was a poor candidate for the procedure.

 
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Brand NameLASIK EYE SURGERY
Type of DeviceLASIK EYE SURGERY
MDR Report Key1222366
Report NumberMW4004357
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/30/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Event Location Unknown
Is this a Reprocessed and Reused Single-Use Device? No

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