BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INIFINITI VISION SYSTEM OZIL

    MDR report key: 1940061 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02462
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE FACILITY DID NOT REQUEST SERVICE AS THE BIOMED FOUND A BURNED INVERTER BOARD AND WILL REPLACE IT. ROOT CAUSE: A ROOT CAUSE HAS NOT BEE IDENTIFIED. ACTIONS TAKEN - NO ADD'L ACTION IS PLANNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SCREEN FROZE, WENT BLACK, AND STARTING SMOKING DURING A PROCEDURE. THE SYSTEM WAS SWITCHED OUT AND THE SURGERY WAS COMPLETED AS PLANNED. THERE WAS A REPORTED DELAY IN PROCEDURE, BUT THE PT'S OUTCOME WAS UNAFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1