BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 20185288 · Received September 9, 2024

    Report

    Report Number
    MW5159421
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    HQC
    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

    THE PATIENT UNDERWENT A VITRECTOMY WHEN THE CONSTELLATION MACHINE MALFUNCTIONED HALFWAY THROUGH SURGERY. THE AIR-FLUID EXCHANGE MECHANISM WAS NOT WORKING AT ALL. THE MACHINES WERE SWITCHED OUT INTRAOPERATIVELY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475417 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female