BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1033382 · Received April 23, 2008

    Report

    Report Number
    MW5006361
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    August 1, 1999
    Report Date
    April 23, 2008
    Manufacturer
    *
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LASIK SURGERY, AFTER MILD VISION LOSS WAS STABLE FOR THREE PLUS YRS. PROCEDURE PERFORMED BY A DR. IMMEDIATELY AFTER SURGERY - SEVERE SENSITIVITY TO LIGHT, LASTING MORE THAN 6 MONTHS, DRY EYES, HOWEVER, VISION WAS 20/15 WITHIN 24 HRS. FOUR YRS LATER, TROUBLE WITH SENSITIVITY TO LIGHT, MIGRAINES FROM VISION STRAIN. WENT TO DIFFERENT DOCTOR - ONE OF THE LEADING ONES IN THE AREA - AND FOUND THAT I HAVE SEVERE DAMAGE TO THE EYE, THAT CANNOT EVER BE REPAIRED - EVEN BY "SPECIAL" LASER IN ANOTHER COUNTRY. DURING THE SURGERY, IT APPEARS THEY OVER CORRECTED AND TOOK AWAY SO MUCH TISSUE THAT THERE IS NOTHING LEFT TO WORK WITH. ASTIGMATISM WAS OVER CORRECTED AND NOW MY EYE IS "FLAT" BOTH WITH REFLECTING VISION, AND WITH THE ACTUAL SURFACE. I HAVE SEVER DOUBLE VISION, AND CANNOT GO WITHOUT PRESCRIPTION GLASSES. I'VE TRIED EVERY CONTACT LENS ON THE MARKET CURRENTLY, AND AN UNABLE TO KEEP THEM IN MY EYE, AS THE SHAPE OF MY EYE IS SO FLAT. SEVERE DRY EYES, SENSITIVITY TO LIGHT HAS RETURNED AS MY VISION GETS WORSE. NOW, 9 YRS LATER, I AM IN GLASSES FULL TIME, AND HAVE MY RX CHANGED FOR THEM EVERY YR OR SO. HAVE GIVEN UP ON CONTACT LENSES. NINE YEARS LATER AND WORK FULL TIME ON A HORSE FARM...I HAD THE SURGERY SO THAT I DIDN'T HAVE TO WORRY ABOUT GETTING DIRT IN MY CONTACTS, NOW, I HAVE TO FIND GLASSES THAT ALLOW ME TO WORK, BUT DON'T GET IN THE WAY WHEN TRAINING HORSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASIK EYE SURGERY LZS *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention