BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3963332 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00949
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED DURING A LEFT EYE CATARACT SURGERY. DUE TO THIS EVENT, THERE WAS A SUDDEN INTERRUPTION OF THE PHACOEMULSIFICATOR FUNCTIONS. THE IRRIGATION AND ASPIRATION STOPPED WORKING. THE EVENT OCCURRED DURING THE PHACO PHASE AND LASTED 15 MINUTES. THE CASSETTE WAS REMOVED AND THEN THE SYSTEM REPRIMED. THE SURGERY COULD BE CONTINUED WITHOUT ANY FURTHER ISSUE. THERE WERE NO PATIENT CONSEQUENCES, BUT IMPORTANT DISSATISFACTION OF THE SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301442 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR

    Patients

    Seq Age Sex Outcome Treatment
    1 DUOVISC| CENTURION CASSETTE