BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1880189 · Received October 15, 2010

    Report

    Report Number
    2028159-2010-02022
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM. THE REPRESENTATIVE ATTEMPTED TO RESEAT THE U/S PCB AND CABLES. SUBSEQUENTLY, THE U/S PCB WAS REPLACED. CALIBRATION WAS VERIFIED AND OPERATIONS WERE DISCUSSED WITH STAFF. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE U/S PCB 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED IN THE MIDDLE OF A CASE A SYSTEM MESSAGE WAS DISPLAYED. THE SYSTEM WAS SWAPPED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS WAS THE SECOND TIME THIS ISSUE HAD OCCURRED (THE FIRST A WEEK EARLIER). THE SYSTEM WAS SWITCHED OUT IN BOTH INSTANCES AND THE CASES WERE COMPLETED. THERE WAS NO PATIENT IMPACT IN EITHER CASE. THERE WAS A DELAY OF NOT GREATER THAN 30 MINUTES WHILE THE SYSTEM WAS SWITCHED OUT.

    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