BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK EYE SURGERY

    MDR report key: 3934355 · Received July 10, 2014

    Report

    Report Number
    MW5037238
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 1, 2007
    Report Date
    July 9, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LASIK EYE SURGERY IN (B)(6) 2007. SINCE THEN, I HAVE SEVERE DRY EYES ALWAYS REQUIRING EYE DROPS AND ALSO HALOS AROUND LIGHTS AT NIGHT TIME. IN ADDITION, IN ONLY A FEW YEARS MY VISION DEGRADED TO THE POINT OF NEEDED GLASSES AGAIN, COMPLETELY NULLIFYING THE PURPOSE OF THE SURGERY. IN ADDITION I FEEL IT WAS NOT FULLY EXPLAINED HOW THE CORNEAL FLAP NEVER FULLY HEALS, AND ONLY HEALS TO A FEW PERCENT OF THE ORIGINAL STRENGTH. I KNEW THE VISION MAY WORSEN (THOUGH THEY SAID MORE LIKE 30 YEARS), BUT DID NOT KNOW IF NEVER FULLY HEALS. THAT ALONE AS I AM INTO SPORTS ETC, WOULD HAVE ENOUGH TO SKIP THE PROCEDURE. IN ADDITION, MY NIGHT VISION IS WORSE, HALOS OVER LIGHTS, AND COMPUTER SCREENS ALWAYS LOOK OUT OF FOCUS FOR WHATEVER REASON AS WELL. I FELL I TRADED 3 YEARS OF DECENT VISION FOR A WHOLE LIST OF OTHER ISSUES IN ADDITION TO MY "OLD" VISION RETURNED IN ONLY 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402538 LASIK EYE SURGERY LASE OPTHALMIC LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR