BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX

    MDR report key: 178178 · Received July 17, 1998

    Report

    Report Number
    178178
    Event Type
    Injury
    Date Received
    July 17, 1998
    Date of Event
    June 26, 1998
    Report Date
    July 9, 1998
    Manufacturer
    VISX, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PLANNED TO DO PRKA FOLLOWED BY PTK. LASER PROGRAMMER PUT IN INFO FOR PTK FIRST. THE SURGEON BELIEVED THAT A PRKA WAS BEING PERFORMED. ON REVIEW OF THE PRINTOUT AT THE END OF THE FIRST PROCEDURE IT WAS REALIZED THAT PTK WAS PERFORMED RATHER THAN PRKA. THE PERIPHERAL PTK PROCEEDED WITH APPARENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS VISX, INC. STAR (MODELC) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention NO KNOWN MEDICATIONS.