BEUDAMED
    FDA Adverse Event Injury Summary report: N

    000

    MDR report key: 1917771 · Received December 4, 2010

    Report

    Report Number
    MW5018484
    Event Type
    Injury
    Date Received
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    000
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOR THE LAST COUPLE OF YEARS AND HAS PROGRESSIVELY GOTTEN WORSE, I HAVE BAD NIGHT VISION. WHEN I HAD MY LASIK DONE FOR FREE -THROUGH LOCAL TV STATION 1/2 HR LIVE SPECIAL-, I HAVE HAD ISSUES WITH NIGHT DRIVING OR HALOS. HOWEVER, AFTER I HAD THE SURGERY, IT WAS CORRECTED. NOW, ABOUT 8 YEARS LATER, IT HAS PROGRESSIVELY GOTTEN WORSE TO THE POINT, I HATE TO DRIVE AT NIGHT OR EVEN LOOK AT MY TV WHEN IT IS LIGHT LETTERING AND A DARK BACKGROUND. IT IS COMPLETELY 100% WORSE THAN IT WAS WHEN I FIRST GOT THE LASIK SURGERY. I WAS PICKED FOR THE TELEVISION EPISODE BECAUSE OUT OF ALL THE 5 OR 6 PEOPLE INTERVIEWED, I WAS THE "EASIEST" TO DO AND THE OUTCOME WOULD BE GREAT FOR THEM TO PROMOTE THEIR PRODUCT. THIS WAS DONE THROUGH LASIK. IT IS BECOMING UNBEARABLE AND A NUISANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 000 000 LZS 000 000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other