BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2042966 · Received February 23, 2011

    Report

    Report Number
    2028159-2011-00162
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THAT THE HANDPIECES WERE NOT BEING RECOGNIZED. THE U/S CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET ALL PRODUCT SPECS. THE REP ALSO FOUND THAT ONE OF 3 HANDPIECES WAS NON FUNCTIONING. THE OTHER TWO HANDPIECES WERE ABLE TO PASS FUNCTIONAL TESTING. THE COMPANY REP NOTED THAT THE CUSTOMER WAS USING HANDPIECES THAT WERE REFURBISHED BY ANOTHER COMPANY. THE U/S CONTROLLER PCB IS EXPECTED TO RETURN FOR IN-HOUSE TESTING. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A CATARACT EXTRACTION PROCEDURE, THE HANDPIECE WAS NOT RECOGNIZED BY THE SYSTEM AND THERE WAS NO SUCTION DURING PHACOEMULSIFICATION. THE HANDPIECE WAS EXCHANGED BUT THE ISSUE CONTINUED. ANOTHER SYSTEM WAS USED TO COMPLETE THE SURGERY. IN A F/U, THE HEALTHCARE PROFESSIONAL REPORTED THE SYSTEM AND INITIAL HANDPIECE PRIMED SUCCESSFULLY BEFORE THE PROCEDURE. THE HANDPIECE(S) USED AS ALTERNATIVES WERE NOT RECOGNIZED BY THE SYSTEM. THE SURGERY WAS COMPLETED WITH ANOTHER SYSTEM USING AN ALTERNATIVE IRRIGATION AND ASPIRATION TECHNIQUE TO REMOVE THE CRYSTALLINE LENS. AS A RESULT, THE PROCEDURE WAS PROLONGED. THERE WAS NO HARM OR INJURY TO THE PT.

    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