BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES 10K MASTER

    MDR report key: 34973 · Received July 17, 1996

    Report

    Report Number
    34973
    Event Type
    Other
    Date Received
    July 17, 1996
    Date of Event
    April 9, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 4/9/96, THE CATARACT EXTRACTOR UNIT FAILED TO GENERATE VACUUM DURING A CATARACT PROCEDURE. THE UNIT EXHIBITED PROBLEMS WITH VACUUM, SUCTION AND COULD NOT BE RELIED UPON TO WORK CONSISTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 10K MASTER CATARACT EXTRACTOR, SERIES 10K MASTER HQC ALCON SURGICAL, INC. STTM

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other