BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON PHACO HANDPIECE

    MDR report key: 34822 · Received June 11, 1996

    Report

    Report Number
    34822
    Event Type
    Malfunction
    Date Received
    June 11, 1996
    Date of Event
    June 4, 1996
    Report Date
    June 10, 1996
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON FOUND PIECE OF METAL ON EYE UPON INITIATION OF PHACO HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON PHACO HANDPIECE PHACO HANDPIECE HQC ALCON SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR