BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON CENTURION VISION SYSTEM

    MDR report key: 11364773 · Received February 22, 2021

    Report

    Report Number
    MW5099531
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 17, 2021
    Report Date
    February 18, 2021
    Manufacturer
    ALCON / ALCON RESEARCH, LLC
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALCON CENTURION VISION SYSTEM FAILED TO PROVIDE ASPIRATION AND IRRIGATION FOR THE SURGEON DURING A PHACO PROCEDURE. RESULTING IN THE SURGEON HAVING TO COMPLETE THE PROCEDURE USING MANUAL IRRIGATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260553 ALCON CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON / ALCON RESEARCH, LLC CENTURION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR