BEUDAMED
    FDA Adverse Event Other Summary report: N

    NYDAK LASER

    MDR report key: 281750 · Received June 10, 2000

    Report

    Report Number
    MW1019108
    Event Type
    Other
    Date Received
    June 10, 2000
    Date of Event
    March 6, 1999
    Report Date
    June 10, 2000
    Manufacturer
    NIDEK, INC.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POST LASIK EYE SURGERY PROBLEMS. PT'S VISION AT NIGHT AND IN ARTIFICIAL LIGHT SITUATIONS IS IMPAIRED. GHOSTING AND HALOS MAKE DRIVING VERY DIFFICULT. ARTIFICIAL LIGHTING IN INTERIOR SPACES CREATES SIMILAR PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NYDAK LASER LASER FOR CORRECTIVE EYE SURGERY LZS NIDEK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other