BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION

    MDR report key: 12048994 · Received June 23, 2021

    Report

    Report Number
    12048994
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 25, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER DR, THE HAND PIECE ON THE PHACO WAS NOT WORKING CORRECTLY, WHICH CAUSED A THERMAL BURN TO THE PATIENT'S RIGHT CATARACT WOUND, WHICH THEN REQUIRED A NYLON SUTURE CLOSURE. MANUFACTURER RESPONSE FOR PHACO EMULSIFICATION SYSTEM, ALCON (PER SITE REPORTER) IT WAS VERIFIED THAT THE CENTURION OPERATION PERFORMED TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948179 CENTURION UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC CENTURION

    Patients

    Seq Age Sex Outcome Treatment
    1