BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI-MED

    MDR report key: 142165 · Received January 8, 1998

    Report

    Report Number
    MW1012759
    Event Type
    Injury
    Date Received
    January 8, 1998
    Date of Event
    November 14, 1997
    Report Date
    January 8, 1998
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR IS CONCERNED ABOUT POSSIBLE MISUSE OF LASER OR INADEQUATE INSTRUCTIONS FROM MFR REGARDING APPROPRIATE CANDIDATES FOR LASIK PROCEDURE USING THIS LASER DUE TO ITS LIMITATIONS. RPTR HAS SUFFERED IRREVERSIBLE DOUBLE VISION AND DISTORTION, EVEN AFTER CORRECTION. RPTR HAS INVESTIGATED DIFFERENT LASERS ON THE MARKET AND FOUND THAT THIS PARTICULAR LASER SHOULD NOT BE USED ON PT'S WITH MILD TO MODERATE ASTIGMATISM BECAUSE IT CANNOT CORRECT THE ASTIGMATISM ONLY THE SPHERE RESULTING IN DISTORTION AND DOUBLE VISION. RPTR IS ALSO CONCERNED BECAUSE THIS PARTICULAR REFRACTIVE SURGEON IS DOING MANY CASES WEEKLY USING A SINGLE SETTING FOR ALL PTS AND NOT ACCOUNTING FOR THE ASTIGMATISM. RPTR IS UNCERTAIN WHETHER THE MFR HAS MADE USERS AWARE OF THE LASERS LIMITATIONS OR WHETHER THIS USER IS GOING AGAINST RECOMMENDATION FOR FINANCIAL REASONS OR CONVENIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-MED OPHTHALMIC LASER REFRACTIVE WORK STATION HQF SUMMIT TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR