BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1940132 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02432
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    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 SERVICE REP EXAMINED THE SYSTEM AND THE REPORTED SYSTEM MESSAGE WAS CONFIRMED. THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE FLUIDICS MECHANISM ASSEMBLY AND THE FOOTSWITCH CABLE WERE REPLACED AS A PRECAUTION. PREVENTIVE MAINTENANCE WAS ALSO PERFORMED ON THE SYSTEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE FLUIDICS MECHANISM ASSEMBLY AND FOOTSWITCH CABLE HAVE 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, A FOOTSWITCH ISSUE OCCURRED. THE SYSTEM WAS QUICKLY EXCHANGED WITH ONE FROM ANOTHER ROOM. THE CASE WAS COMPLETED AFTER A DELAY OF APPROXIMATELY 10 MINUTES. THERE WAS NO HARM TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK