BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3810759 · Received March 21, 2014

    Report

    Report Number
    2028159-2014-00448
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A CATARACT SURGERY, WHEN HE STEPPED ON THE FOOT PEDAL, THE PHACO POWER WENT TO 100% AND THERE WAS NO LINEAR CONTROL. IN A FOLLOW UP PHONE CALL, A NURSE INDICATED THE DOCTOR EXPERIENCED A LOT OF "CHATTER" DURING PHACO MODE AND THE LONGITUDE SETTINGS DISPLAYED "0" AND WOULD NOT MOVE. WHEN THE PHACO HANDPIECE WAS REMOVED FROM THE EYE, THE SETTINGS WOULD MOVE. THE HANDPIECE WAS REPRIMED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169695 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK