BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 539330 · Received March 26, 2004

    Report

    Report Number
    2028159-2004-00070
    Event Type
    Malfunction
    Date Received
    March 26, 2004
    Date of Event
    February 26, 2004
    Report Date
    February 27, 2004
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED ERROR MESSAGE DURING SURGERY; SHUT OFF UNIT AND BROUGHT IN BACK-UP. HAD TO DO A VITRECTOMY. ADDITIONAL INFORMATION RECEIVED IN 2004 NOTED EDEMATOUS CORNEA AND CORNEAL BURN RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR