BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2172142 · Received June 24, 2011

    Report

    Report Number
    2028159-2011-00725
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 26, 2011
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM, FOUND THE FOOTSWITCH CABLE WAS NOT FUNCTIONING PROPERLY AND REPLACED IT. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THE FOOTSWITCH CABLE WAS RETURNED FOR IN-HOUSE EVALUATION. VISUAL EVALUATION OF THE RETURNED FOOTSWITCH CABLE DID NOT REVEAL ANY NONCONFORMITY. THE FOOTSWITCH CABLE WAS TESTED AND THE SYSTEM DID NOT RECOGNIZE WHEN THE TREADLE WAS DEPRESSED. THE TREADLE WAS FULLY DEPRESSED SEVERAL TIMES, BUT THE FOOTSWITCH ICON INDICATED THE FOOTSWITCH REMAINED IN POSITION ZERO. THE CABLE WAS REMOVED FROM THE CONSOLE AND TESTED FOR CONTINUITY. CONTINUITY TESTING REVEALED A BREAK IN THE CONDUCTOR AT PIN 4. IF THE SYSTEM WAS UNABLE TO CYCLE TO DIFFERENT FOOTSWITCH POSITIONS, THE SYSTEM WOULD NOT PROVIDE IRRIGATION, ASPIRATION, OR PHACO POWER. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, IT IS UNKNOWN IF IRRIGATION AND ASPIRATION WERE PROVIDED BY THE SYSTEM AND IT CANNOT BE DETERMINED IF THE OBSERVED FOOTSWITCH ISSUE CONTRIBUTED TO THE CUSTOMER REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. EVALUATION OF THE RETURNED FOOTSWITCH CABLE REVEALED A BREAK IN CONTINUITY ON PIN 4 OF THE CABLE. HOWEVER, WITH THE PROVIDED INFORMATION, IT CANNOT BE DETERMINED IF THE OBSERVED FOOTSWITCH ISSUE CONTRIBUTED TO THE CUSTOMER REPORTED HANDPIECE ISSUE. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THE HANDPIECE HAD NO INTERMITTENT CAPABILITIES DURING SURGERY. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    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