BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 3926579 · Received July 7, 2014

    Report

    Report Number
    MW5037097
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 3, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2008, I HAD LASIK. TWO YEARS LATER, I HAD A POSTERIOR VITREOUS DETACHMENT IN THE LEFT EYE AND NOW SIX YEARS LATER, I HAVE HAD A POSTERIOR VITREOUS DETACHMENT IN THE RIGHT EYE. I HAVE VERY LARGE BLACK FLOATERS IN BOTH EYES AND A HAZE OR CLOUDY AREA IN BOTH EYES THAT MAKE IT IMPOSSIBLE TO FOCUS CLEARLY. GLASSES WILL NOT CORRECT THIS BECAUSE THE CLOUDINESS IS IN MY VITREOUS. I WAS MYOPIC PRESURGERY WITH BOTH EYES BEING ABOUT A -6 DPT. NOBODY ADVISED ME THAT THIS COULD BE A SIDE EFFECT. I NOW FEEL LIKE I AM PARTIALLY BLIND. I'VE ALSO BEEN ON RESTASIS FOR SIX YEARS AND HAVE JUST SWITCHED TO A AUTOLOGOUS SERUM EYEDROPS FOR MY DRY EYE. THE EYEDROPS HAVE IMPROVED THE HEALTH OF MY CORNEA BUT IT DOES NOT HELP WITH THE POSTERIOR VITREOUS DETACHMENT. IF ONLY I HAD A TIME MACHINE TO GO BACK AND NOT CHOOSE THIS SURGERY. WHY WASN'T I TOLD THIS COULD BE A RISK. NOW I WORRY IN THE NEXT FEW YEARS WHAT THE NEXT SURPRISE WILL BE FROM THIS NIGHTMARE OF A SURGERY CALLED LASIK. I DON'T UNDERSTAND WHY IT IS LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393143 LASIK LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability