BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1880196 · Received October 15, 2010

    Report

    Report Number
    2028159-2010-02002
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. PREVENTIVE MAINTENANCE WAS PERFORMED. FOOTPEDAL PROBLEMS WERE NOTED MIDWAY THROUGH THE PREVENTIVE MAINTENANCE. THE FOOTPEDAL CABLE WOULD NOT LOCK IN ITS CONNECTOR VIA THE FOOTPEDAL. INTERMITTENT ERROR CODES WERE RECEIVED DURING SEVERAL BOOT-UPS. THE LEFT VERTICAL SWITCH DID ACTIVATE REFLUX. DUE TO THE ERROR CODES FOUND, THE REP ADVISED THE FACILITY THE FOOTPEDAL NEEDED TO BE REPLACED. THE SOLENOID SPACERS AND FOOTPEDAL CABLE WERE REPLACED AND ALL THE FILTERS WERE CLEANED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE CUSTOMER WILL HAVE THE FOOTPEDAL REPLACED. THE REPLACED SOLENOID SPACERS WERE DISPOSED OF ONSITE BUT THE REPLACED FOOTPEDAL CABLE WILL BE RETURNED FOR IN-HOUSE TESTING. INVESTIGATION INCLUDING ROOT CASE 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 THE REFLUX WASN'T COMING ON WHEN FOOTSWITCH WAS DEPRESSED. THE SURGEON ASKED THE STAFF TO PINCH THE TUBING TO COMPLETE THE CASE. THE SYSTEM AND THE FOOTSWITCH WERE REMOVED FROM ROTATION AFTER THE CASE. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1