BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 53171 · Received August 2, 1996

    Report

    Report Number
    53171
    Event Type
    Malfunction
    Date Received
    August 2, 1996
    Date of Event
    May 23, 1995
    Report Date
    February 16, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE TWO OF THE PHACOMACHINES MALFUNCTIONED. TRIED DIFFERENT HANDPIECES AND THREE DIFFERENT CASSETTES IN BOTH OF THE MACHINES AND IT CONTINUED TO READ "LOW-VAC" WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HQC ALCON LABORATORIES * WA 215 03 1995.03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other