BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 3881125 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00611
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE.(B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED SEVERAL TIMES DURING A CATARACT PROCEDURE, INDICATING OBSTRUCTION IN THE DEVICE, LIQUID CAN NOT FLOW OUT OF THE FLUIDICS MODULE SYSTEM. THE HANDPIECE AND THE PHACO TIP WERE CHANGED, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AFTER REPLACING THE FLUIDICS MODULE SYSTEM AND THE TUBING. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES TO THE PT. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVAL. THERE ARE NO ADD'L EVENT DETAILS EXPECTED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214162 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON -IRVINE TECHNOLOGY CTR INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFINITI MP BASIC S.A