BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK 5000

    MDR report key: 3926568 · Received July 1, 2014

    Report

    Report Number
    MW5037095
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 30, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD PRK/LASIK DONE ON BOTH EYES FROM NIDEK 5000 LASER WITH BAD RESULTS. ALL CLOSE UP VISION IS GONE, INTERMEDIATE VISION GROSSLY DISTORTED AND DOUBLE VISION IN RIGHT EYE. NOT SURE IF IT WAS BECAUSE OF IMPROPER DEVICE USED OR MALFUNCTION OR WHAT BUT MY EYES HAVE POOR NIGHT VISION LIGHT SENSITIVITY. I ALSO DON'T BELIEVE THIS PROCEDURE SHOULD OF BEEN ALLOWED ON MY EYES. EVEN IF IT'S OFF LABELED USE. THIS LASIK PROCEDURE HAS RUINED MY EYES AND I STRUGGLE DAILY WITH VISION PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381616 NIDEK 5000 NIDEK 5000 LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other