BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFICIENT PHACO HANDPIECE

    MDR report key: 34374 · Received July 23, 1996

    Report

    Report Number
    MW1009544
    Event Type
    Injury
    Date Received
    July 23, 1996
    Date of Event
    May 21, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A DARK SPECK WAS NOTED ON PHACO TIP BEFORE IT WAS INTRODUCED INTO THE EYE SO THE TIP WAS REPLACED WITH STERILE NEW TIP. AFTER PRIMING, SEVERAL DARK PIECES WERE FOUND IN THE IRRIGATION CONDOM. THE HANDPIECE AND TIP WERE REPLACED BEFORE SURGERY PROCEEDED. AFTER COMPLETION OF THE PHACO PORTION OF SURGERY, ON THE FOLLOWING CASE, SEVERAL FLECKS OF METALLIC APPEARING FRAGMENTS WERE NOTICED IN THE ANTERIOR CHAMBER OF THE EYE. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENTS. THERE WERE NO VISIBLE FRAGMENTS NOTED AFTER IRRIGATION/ASPIRATION. VISIBLE MICROSCOPE OBSERVATIONS SUGGESTS SOME METAL FRAGMENTS COME FROM THE HANDPIECE. ALSO, DISCOLORATION SUGGESTS DOME DETERIORATION. FIVE METAL FRAGMENTS SENT FOR IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFICIENT PHACO HANDPIECE PHACO HANDPIECE HQC ALLERGAN MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention