BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 735536 · Received June 16, 2006

    Report

    Report Number
    2028159-2005-00093
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Report Date
    May 17, 2005
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: WAITING FOR EVALUATION RESULTS. THIS REPORT MAILED IN TO FDA ON: 06/16/2005. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: IA050610.

    Description of Event or Problem · 1

    REPORTER NOTED SYSTEM RESET ITSELF DURING SURGERY, PT UNDER ANESTHESIA, ABORTED CASE; CANCELED ANOTHER. NO PT INJURY OCCURRED.

    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