BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 153948 · Received February 27, 1998

    Report

    Report Number
    2028159-1998-00054
    Event Type
    Malfunction
    Date Received
    February 27, 1998
    Date of Event
    February 10, 1997
    Report Date
    February 13, 1998
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER HAS BEEN FOLLOWING PT WITH HISTORY OF MACULAR DEGENERATION. VISION IS 20/30 AND DECREASING SLIGHTLY. METAL PARTICLE DETECTED POST-OP ON IRIS, CLOSE TO PUPIL, BUT NO INFLAMMATION. USES TWO HANDED TECHNIQUE TO PHACO. INITIAL SURGERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON LABORATORIES, INC. STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR