BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASIK SURGERY

    MDR report key: 1033968 · Received April 24, 2008

    Report

    Report Number
    MW5006396
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 30, 1999
    Report Date
    April 24, 2008
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS A SIDE EFFECT OF LASIK SURGERY, I HAVE PERMANENT HALOS AND GLARE IN LOW LIGHTING SITUATIONS, DAWN, DUSK, NIGHTTIME, DARK THEATRES. I AM REPORTING THIS NOW BECAUSE I JUST READ ABOUT IT ON THE FDA WEBSITE, AND HEARD ABOUT THE FDA REVIEW OF COMPLICATIONS FROM LASIK. I DON'T HAVE THE EXACT DATE OF MY SURGERY AVAILABLE, BUT IT WAS APPROX 9 YRS AGO. THE SURGERY WAS PERFORMED BY DR. AT A LASIK SURGERY CTR. DIAGNOSIS OR REASON FOR USE: TO CORRECT NEAR-SIGHTEDNESS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK SURGERY LASIK LASER LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other