BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION LXT, SN VITRECTOMY

    MDR report key: 8658494 · Received May 30, 2019

    Report

    Report Number
    MW5087037
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT LEFT EYE VITRECTOMY, MEMBRANE PEEL (GAS OR SILICONE OIL). TOWARDS THE END OF THE PROCEDURE, THE ALCON CONSTELLATION VITRECTOMY MACHINE MALFUNCTIONED AND CEASED, WHEREBY A YELLOW ERROR 2251 MESSAGE APPEARED ON THE SCREEN. APPROX 1-2 MINS LATER, FUNCTIONALITY OF THE VITRECTOMY UNIT RETURNED, AND THE RETINA HAD REDETACHED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447174 CONSTELLATION LXT, SN VITRECTOMY UNIT, PHACOFRAGMENTATION HQC ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR