BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXIMER LASER FOR PRK & PTK

    MDR report key: 26540 · Received October 5, 1995

    Report

    Report Number
    MW1007210
    Event Type
    Malfunction
    Date Received
    October 5, 1995
    Report Date
    September 28, 1995
    Manufacturer
    UNKNOWN
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PHYSICIAN HAS BEEN PERFORMING LASER SURGERY ON PTS USING THIS DEVICE. THIS DEVICE IS ALLEGEDLY A BLACK MARKET LASER THAT HAS NOT BEEN APPROVED IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXIMER LASER FOR PRK & PTK LASER HQF UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA