BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCUTOME

    MDR report key: 35091 · Received August 8, 1996

    Report

    Report Number
    MW1009668
    Event Type
    Malfunction
    Date Received
    August 8, 1996
    Date of Event
    July 15, 1996
    Report Date
    July 29, 1996
    Manufacturer
    ALCON SURGICAL
    Product Code
    MLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON WENT TO USE PROBE IN THE EYE, HE COULD NOT GET THE CUTTING TO WORK. HE TRIED A SECOND PACK WITH THE SAME RESULTS AND DECIDED TO CLOSE THE EYE AND CANCEL THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCUTOME SURGICAL CUTTER MLZ ALCON SURGICAL STT04000 (1085A PACK)

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other DISPOSABLE HANDPIECE (1085A)