BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON CONSTELLATION LXT

    MDR report key: 4060106 · Received August 20, 2014

    Report

    Report Number
    MW5038044
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ALCON
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO OPERATING ROOM FOR PLANNED EPIRETINAL MEMBRANECTOMY. SURGERY WAS IN PROGRESS AND ICG HAD BEEN INJECTED TO STAIN THE RETINA. THE NEW CONSTELLATION MACHINE GAVE AN ERROR CODE 3099 FLUID FAILURE. THE ICG WAS FLUSHED WITH BSS IN SYRINGES. THE RETINA WAS DISCOVERED TO BE DETACHED AND THE PATIENT REQUIRED UNEXPECTED LASER AND SILICONE OIL PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503835 ALCON CONSTELLATION LXT CONSTELLATION LXT HQC ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention