BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1852887 · Received September 29, 2010

    Report

    Report Number
    MW5017621
    Event Type
    Injury
    Date Received
    September 29, 2010
    Report Date
    September 29, 2010
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVEN YRS AFTER HAVING LASIK EYE SURGERY, I NOW HAVE CORNEAL ECTASIA. I WAS (B)(6) AT THE TIME OF MY SURGERY AND I PASSED THROUGH ALL PRESCREENING TESTS WITH NO PROBLEMS. MY VISION WAS GREAT FOR ABOUT 6 YRS AND IT HAS STEADILY GOT WORSE OVER THE PAST YR AND A HALF. I DON'T REALLY KNOW WHAT MY VISION IS NOW BUT I'M UNABLE TO FUNCTION WELL WITHOUT MY GLASSES AND THEY DON'T HELP MUCH. I'VE RECENTLY GOT GAS PERMEABLE HARD CONTACTS AND IT HAS CORRECTED MY VISION TO 20/20. I DO HAVE CONCERNS THAT EITHER THE LASIK WAS NOT DONE CORRECTLY OR THE "1 IN 2000 CHANCE" OF SOMETHING GOING WRONG WITH THE PROCEDURE IS A FALSE STATEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR