BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3881108 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00610
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT SAMPLE WAS RECEIVED AND IT IS AWAITING EVAL. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED DURING THE PRE PHACO PORTION OF A CATARACT PROCEDURE INDICATING POSSIBLE LOOSE PHACO TIP. THE PHACO TIP WAS IN THE EYE AT THE TIME OF THE EVENT. SINCE THERE WAS NO PHACO POWER, THE SURGEON PROCEEDED TO ADVANCED QUAD MODE AND CONTINUED WITH THE PROCEDURE. THE REPORTER INFORMED THAT THE SURGEON COMMENTED DURING THE SURGERY THAT HE THOUGHT THAT THE PHACO TIP MIGHT HAVE NOT BEEN TIGHT ENOUGH AT THE TIME OF THE EVENT. ADD'L INFO HAS BEEN REQUESTED FOR THIS CASE, HOWEVER, NO UPDATES HAVE BEEN RECEIVED DURING F/U. A PRODUCT SAMPLE WAS RECEIVED AND IT IS AWAITING EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213586 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON -IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CENTURION CASSETE