BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1052885 · Received May 27, 2008

    Report

    Report Number
    MW5007047
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    July 1, 2006
    Report Date
    May 27, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LASIK SURGERY IN 1999-?-. IN 2006, NOTICEABLE DECLINE IN VISION QUALITY SUDDEN BEGAN. IN 2007, PATIENT WAS SEEN AGAIN BY SURGEON. IN 2008, PATIENT WAS TOLD HE HAD CONE SHAPED CORNEAS AND SHOULD BE ENROLLED IN THE FDA TRIAL. NO OTHER RECOURSE WAS OFFERED. RESEARCH DEPT'S PACKET STRONGLY INSINUATED THAT THE LASIK WAS THE CAUSE OF THE NOW DEGRADING EYESIGHT. PATIENT REQUIRES GLASSES ONCE AGAIN AND VISION IS CONSTANTLY CHANGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability