BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX

    MDR report key: 2820890 · Received October 29, 2012

    Report

    Report Number
    MW5027429
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 9, 2010
    Report Date
    October 29, 2012
    Manufacturer
    VISX
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) PERFORMED LASIK SURGERY ON ME KNOWING THAT I HAVE FIRST DEGREE RELATIVE WITH KERATOKONUS. I HAD 10 DIOPTERS OF MYOPIA AND WAS TREATED WITH LASIK EYE SURGERY - NOT PRK. AFTER THE FACT I HAVE LEARNED THAT I SHOULD NOT HAVE BEEN A CANDIDATE. I AM AFRAID I WILL DEVELOP, BECAUSE OF (B)(6) DOING LASIK ON ME WITHOUT DISCLOSING COMPLICATIONS OF BEING A HIGH MYOPE, (B)(6) AND FIRST DEGREE RELATIVE WITH KERATOCONUS, ECTASIA DUE TO HAVING LASIK THAT I MAY NOT HAVE OTHERWISE BEEN AT RISK FOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR