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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 10/07/2009
Event Type  Injury  
Event Description

Had lasik eye surgery done. I am suffering with a haze, double vision and am unable to drive and having a very hard time going to work. I saw that the fda was looking into lasik surgery on the television today. An employee in the office where i went informed me that at least three people have problems that had lasik surgery on the same day as myself. At this point, i am very concerned and in the process of making a new appointment to have a second opinion.

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Type of DeviceLASIK
MDR Report Key1513505
Report NumberMW5013067
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/16/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2009
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No