BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 158841 · Received March 18, 1998

    Report

    Report Number
    2028159-1998-00073
    Event Type
    Malfunction
    Date Received
    March 18, 1998
    Date of Event
    January 27, 1998
    Report Date
    February 18, 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 NOTED METAL PARTICLE ON IRIS DURING POST-OP SLIT LAMP EXAMINATION. EYE IS QUIET, NO INFLAMMAION. NO INTERVENTION PLANNED.

    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 63 YR