BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1940123 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02428
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 23, 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

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND THE REPORTED SYSTEM MESSAGE WAS CONFIRMED. THE FLUIDICS MECHANISM ASSEMBLY WAS REPLACED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE FLUIDICS MECHANISM ASSEMBLY HAS BEEN RECEIVED FOR FURTHER IN-HOUSE EVALUATION. 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 HEALTHCARE PROFESSIONAL, REPRESENTING THE SURGERY CENTER, REPORTED THAT MULTIPLE SYSTEM MESSAGES WERE RECEIVED DURING THE SURGERY. THE SYSTEM WAS REBOOTED, AND THE CASE WAS COMPLETED AFTER A SHORT DELAY. THERE WAS NO PT HARM 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 NI