BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUMMIT

    MDR report key: 106128 · Received July 17, 1997

    Report

    Report Number
    MW1011724
    Event Type
    Other
    Date Received
    July 17, 1997
    Date of Event
    April 1, 1997
    Report Date
    July 17, 1997
    Manufacturer
    SUMMIT TECHNOLOGIES, INC.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PHOTOTHERAPEUTIC KERATOTOMY. AFTER PROCEDURE, PT'S REFRACTION CHANGED, SHE BECAME HYPEROPIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT EXCIMER LASER LZS SUMMIT TECHNOLOGIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other