BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1905536 · Received November 19, 2010

    Report

    Report Number
    2028159-2010-02262
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, THE SYSTEM MESSAGE WAS VERIFIED IN THE EVENT LOG. THE HOST COMPUTER AND POWER DISTRIBUTION PCB WERE REPLACED AND WILL BE SENT FOR IN-HOUSE EVAL. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE HOST COMPUTER AND POWER DISTRIBUTION PCB HAVE BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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 SURGICAL TECH REPORTED DURING A VITRECTOMY, THE SCREEN WHEN BLACK, THEN CAME BACK ON WITH A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS SWITCHED OUT AND THE CASE COMPLETED. THE VITRECTOMY WAS BEING DONE SECONDARY TO A POSTERIOR CAPSULAR RUPTURE (PC TEAR) THAT THE SURGEON REPORTED WAS THE RESULT OF A SURGICAL COMPLICATION. ADDITIONAL INFO WAS REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    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 Required Intervention