BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK LASER DEVICE

    MDR report key: 2000402 · Received February 17, 2011

    Report

    Report Number
    MW5019479
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    September 1, 2002
    Report Date
    February 17, 2011
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS CONCERNING POST LASIK EYE SURGERY AND THE ONGOING DETRIMENTAL AFFECTS I LIVE WITH. THESE INCLUDE REDUCED VISUAL ACUITY, GLARE, DIMINISHED NIGHT VISION AND DRY EYE. ALSO THE WAY MY EYES PERCEIVE LIGHT HAS SIGNIFICANTLY CHANGED. MY ISSUE IS ONE OF A NEGATIVE AFFECT TO MY QUALITY OF LIFE. I CRITICIZE THE REFRACTIVE EYE SURGERY INDUSTRY FOR DOWNPLAYING SIGNIFICANT CHANGES TO PT'S VISION THAT THEY CAUSE AND THEN PORTRAY PTS AS SATISFIED. MY EXPERIENCE WITH LASIK MADE ME REALLY NOT SATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASER DEVICE NONE LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other