BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRK LASER

    MDR report key: 3932753 · Received July 9, 2014

    Report

    Report Number
    MW5037231
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    October 10, 2012
    Report Date
    July 8, 2014
    Manufacturer
    LASIK PLUS
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ORIGINALLY HAD PRK IN THE MILITARY WHILE I WAS ACTIVE DUTY IN (B)(6) 2003. I THEN HAD PRK DONE AGAIN WITH LASIK PLUS IN (B)(6) 2010 AND (B)(6) 2011. MY SURGERY IN (B)(6) 2010 NEVER RESULTED IN 20/20 VISION SO THEY REDID IT IN (B)(6) 2011 FOR FREE. I WAS DIAGNOSED WITH A DETACHED RETINAS IN (B)(6) 2012. THE MACULA DETACHED AND I HAD A SCLERAL BUCKLE IMPLANTED IN THE RIGHT EYE AND LATER IN THE LEFT. THERE IS A SIGNIFICANT LOSS OF VISION IN MY RIGHT EYE (UPPER LEFT QUAD AND DIFFICULTY IN READING DUE TO THE MACULA SEPARATION). DUE TO THE LINE OF PIGMENTATION THE SURGEON FEELS THAT THIS WAS HAPPENING OVER MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399114 PRK LASER LASER OPTHALMIC HQF LASIK PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability