BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1891030 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02106
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE PHACO POWER WAS FOUND TO BE AT THE CORRECT VOLTAGE AND FREQUENCY FOR ALL TEST MODES. THE SYSTEM POWER SUPPLY VOLTAGE WAS CHECKED AND FOUND TO BE WITHIN SPECIFICATIONS. THE CABLES INVOLVED IN PHACO WERE RESEATED. THE REPRESENTATIVE THEN RAN TESTS EVERY 15 MINUTES OVER A 2 HOURS PERIOD WITH NO FAILURES. PREVENTIVE MAINTENANCE WAS THEN PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED WHEN SURGEON SWITCHED TO THE QUADRANT MODE, ALL FUNCTIONS STOPPED. THE HANDPIECE WAS SWITCHED OUT BUT THE SYSTEM WOULD NOT ALLOW THEM TO TEST. THE SYSTEM WAS THEN SWITCHED OUT AND THE CASE WAS COMPLETED USING THE SAME HANDPIECE. THERE WAS A 15 MINUTES DELAY. THERE WAS NO PT IMPACT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1