BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER SURGERY

    MDR report key: 3901712 · Received June 23, 2014

    Report

    Report Number
    MW5036866
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 15, 2008
    Report Date
    June 20, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASER SURGERY IN 2008 ON BOTH EYES AS I COULD NO LONGER WEAR CONTACT LENSES. IN 2009, AT THE AGE OF (B)(6) I STARTED HAVING TROUBLE SEEING AT NIGHT. I ALSO NOTICED BLURRINESS IN BOTH EYES. I WAS TOLD I HAD 20/20 VISION AFTER THE SURGERY. I WENT TO AN EYE DOCTOR IN 2013 AND BARELY PASSED THE EYE TEST TO DRIVE WITHOUT CORRECTIVE LENSES. I WAS TOLD I HAD CATARACTS IN BOTH EYES. I AM NOT OVERWEIGHT, I DO NOT DRINK OR SMOKE. I HAVE NEVER TAKEN STEROIDS AND HAVE NO FAMILY HISTORY OF CATARACTS. I BELIEVE THE LASER SURGERY CAUSED THE CATARACTS. I AM NOW FORCED TO UNDERGO SURGERY AGAIN SO I CAN DRIVE AT NIGHT AND READ SIGNS. MFR NAME: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365770 LASER SURGERY LASER SURGERY LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability