BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK SURGERY

    MDR report key: 1052143 · Received May 23, 2008

    Report

    Report Number
    MW5007022
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    August 2, 2002
    Report Date
    May 23, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASIK SURGERY ON BOTH EYES. PROBLEMS: EVALUATION FOR CANDIDACY DID NOT INCLUDE A THOROUGH EXPLANATION OF THE EFFECTS OF SUBSTITUTING DISTANCE VISION FOR CLOSE VISION IN AN OLDER PERSON. I WAS TOLD THAT I WOULD PROBABLY NEED READING GLASSES. BEFORE THE SURGERY, I WAS ABLE TO TAKE OFF MY GLASSES -WHICH I HAD WORN FOR MYOPIA SINCE AGE 8- AND SEE UP CLOSE. I WAS ABLE TO READ, TO PUT ON MAKEUP, TO CUT MY TOE NAILS, TO SEE FACES UP CLOSE, TO WORK ON THE COMPUTER - IN SHORT, THE VAST MAJORITY OF ACTIVITIES THAT ONE DOES. I COULD NOT DRIVE WITHOUT MY GLASSES OR SEE DISTANCES. AS A RESULT OF THE SURGERY, I COULD DRIVE AND SEE DISTANCES, BUT 99% OF MY DAILY ACTIVITIES WERE NOW NO LONGER AVAILABLE TO ME WITHOUT READING GLASSES. IN ADDITION, I COULD NOT SEE AS WELL WITH THE READING GLASSES. I WORE PROGRESSIVE LENSES BEFORE; I WEAR PROGRESSIVE LENSES TODAY. EIGHT YEARS LATER, I AM STILL ANGRY AND MOURN THE LOSS OF MY VISION EVERY DAY. THE ISSUE IS WHETHER I WAS AN APPROPRIATE CANDIDATE FOR THIS SURGERY IN THE FIRST PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention