BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 543866 · Received March 31, 2004

    Report

    Report Number
    2028159-2004-00077
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Report Date
    March 1, 2004
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED CORNEAL BURN OCCURRED DURING FOUR PROCEDURES ON DIFFERENT DAYS. PT 2 OF 4. ADDITIONAL INFORMATION RECEIVED ON 03/2004 NOTED ALL PTS ARE DOING WELL; ALL HAVE MILD (NEGLIGIBLE) ASTIGMATISM. SURGEON FEELS SOMETHING GOT HOT.

    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 NO INFO