BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM LXT

    MDR report key: 2089907 · Received May 10, 2011

    Report

    Report Number
    MW5020561
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ALCON LABS,
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSTELLATION VISION SYSTEM FAILED TO PRIME CASSETTE 6 TIMES AND DELAYED SURGERY. REPLACED WITH ANOTHER MACHINE AND CASSETTE WORKED PROPERLY. SERIAL NUMBER OF MACHINE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION VISION SYSTEM LXT CONSTELLATION LXT HQC ALCON LABS, CONSTELLATION LXT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR