BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEMS

    MDR report key: 20000226 · Received August 16, 2024

    Report

    Report Number
    MW5158562
    Event Type
    Malfunction
    Date Received
    August 16, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    MLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN AND PHYSICIAN WERE PRIMING AND SETTING PRESSURES FOR A VITRECTOMY CASE. THE VITRECTOMY PACK CASSETTE USED WITH THE CONSTELLATION VISION SYSTEM MACHINE COULD NOT MAINTAIN THE NEEDED PRESSURES. THE PHYSICIAN FELT THAT IT WAS AN ISSUE WITH THE VITRECTOMY PACK. THE PACK WAS SWITCHED OUT FOR A NEW ONE AND NO OTHER PROBLEMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395909 CONSTELLATION VISION SYSTEMS VITRECTOMY, INSTRUMENT CUTTER MLZ ALCON RESEARCH, LLC. 8065752437 16RH1T

    Patients

    Seq Age Sex Outcome Treatment
    1 Male