BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK EXCIMER LASER SYSTEM

    MDR report key: 6724598 · Received July 17, 2017

    Report

    Report Number
    MW5071080
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    January 31, 2017
    Report Date
    July 17, 2017
    Manufacturer
    UNK
    Product Code
    PDU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM A (B)(6) MALE WHO HAD LASIK AFTER A CONSULTATION AND VISION SCREENING. IMMEDIATELY, I EXPERIENCED A SERIES OF ADVERSE REACTION OVER THE NEXT SIX MONTHS MOST NOTABLY RELATED TO MY VISION AT NIGHT. I CONTINUE TO EXPERIENCE PROBLEMS WITH GLARES, HALOS, AND STARBURSTS. EVEN WORSE, THE CONTRAST IN VISION HAS BEEN SEVERELY REDUCED. I ALSO HAVE DRY EYE SYNDROME, WHICH I HAVE TRIED 4 DIFFERENT PRESCRIPTION MEDICATIONS FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500961 LASIK EXCIMER LASER SYSTEM LASER SYSTEM PDU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other