BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACOEMULSIFICAITON DEVICE

    MDR report key: 70625 · Received February 21, 1997

    Report

    Report Number
    MW1010785
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Date of Event
    June 12, 1996
    Report Date
    January 29, 1997
    Manufacturer
    *
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER PHACO WITH REFURBISHED PHACO HANDPIECE, METALLIC FLAKES WERE NOTED SETTLING ON IRIS. DR INFORMED, MGR AND CENTRAL SUPPLY INFORMED. HANDPIECE WAS THEN OUT OF CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACOEMULSIFICAITON DEVICE PHACOEMULSIFICATION DEVICE HQC * 7167 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other