BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 250071 · Received November 12, 1999

    Report

    Report Number
    2028159-1999-00302
    Event Type
    Malfunction
    Date Received
    November 12, 1999
    Report Date
    October 15, 1999
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED METAL PARTICLES ON IRIS DURING POST-OP VISIT. SUSPECTS THEY CAME FROM A TIP.

    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 70 YR