BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1891101 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02038
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY ORDERED A NEW FOOTSWITCH AND CABLE. THE REPLACED FOOTSWITCH HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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 CUSTOMER REPORTED THE FOOTSWITCH WAS WORKING INTERMITTENTLY ON SEVERAL CASES. BETWEEN CASES, THE STAFF SWITCHED OUT THE FOOTSWITCH BUT THE ISSUE REMAINED. THE SYSTEM WAS THEN SWITCHED OUT WHICH RESOLVED THE ISSUE. ALL SCHEDULED CASES WERE COMPLETED. THE CUSTOMER REPORTED THERE MAY HAVE BEEN A ONE MINUTE DELAY WHILE THE SYSTEMS WERE SWITCHED OUT. THERE WAS NO PT IMPACT REPORTED. THIS IS THE SECOND OF TWO REPORTS BEING FILED FOR THIS FACILITY.

    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