BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1845003 · Received September 22, 2010

    Report

    Report Number
    MW5017563
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    September 22, 2010
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK IN (B)(6) 2002, I HAD TO HAVE ONE REVISION. NOW I HAVE BEEN DIAGNOSED WITH A FORM OF KERATOCONUS CAUSED BY THE SURGERY. MY EYE SIGHT IS CHANGING FOR THE WORSE EVERY 6 MONTHS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention