BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 256731 · Received December 21, 1999

    Report

    Report Number
    2028159-1999-00358
    Event Type
    Malfunction
    Date Received
    December 21, 1999
    Date of Event
    December 1, 1999
    Report Date
    December 1, 1999
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED SYSTEM FAILURE FAULT AND BURNED SMELL AT THE START OF PHACO. REPLACED SYSTEM TO COMPLETE CASE. NO PT INJURY.

    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 79 YR