BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEISS VISUMAX

    MDR report key: 10507247 · Received September 8, 2020

    Report

    Report Number
    MW5096471
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    May 10, 2017
    Report Date
    September 3, 2020
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    OTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LASIK PROCEDURE WITH THE ZEISS VISUMAX FEMTOSECOND AND NIDEK EC-5000 EXCIMER LASERS, I DEVELOPED PERSISTENT AND CHRONIC DRY EYE, FLOATERS, HALOS, STARBURST, GLARE, AND POOR NIGHT VISION IN BOTH EYES. I DID NOT PREVIOUSLY EXPERIENCE ANY OF THESE ISSUES PRIOR TO SURGERY. MY SURGEON CLAIMS THESE SIDE EFFECTS ARE EXTREMELY RARE AND/OR UNRELATED TO MY SURGERY, CLAIMS THAT OTHER OPHTHALMOLOGISTS HAVE CONFIRMED ARE UNTRUE. CURRENTLY AT ABOUT 3.5 YEARS AFTER SURGERY, THESE SYMPTOMS HAVE ONLY BECOME WORSE WITH TIME. THESE SYMPTOMS HAVE CAUSED PERSISTENT ANXIETY, PAIN, AND DISCOMFORT, ADVERSELY AFFECTING MY EVERYDAY FUNCTION, ABILITY TO WORK, QUALITY OF LIFE, MENTAL HEALTH, AND GENERAL WELL-BEING. ASIDE RECEIVING MEDICAL TREATMENT FOR THESE SYMPTOMS WHICH ARE CHRONIC AND INCURABLE, I ALSO REQUIRE BEHAVIORAL THERAPY TO MAINTAIN MY WELL-BEING. FLOATERS IN BOTH EYES NOTED BY SEVERAL OPHTHALMOLOGISTS, FROM 2018-2019. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964812 ZEISS VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC, INC.
    964813 NIDEK EC-5000 EXCIMER LASER SYSTEM LZS NIDEK CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Disability