BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1970110 · Received January 14, 2011

    Report

    Report Number
    2028159-2011-00042
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED SYSTEM MESSAGE. THE FOOTSWITCH INTERFACE PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE FOOTSWITCH INTERFACE PCB IS EXPECTED TO RETURN FOR IN HOUSE TESTING. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE UNIT DISPLAYED A SYSTEM MESSAGE DURING A CASE. THE SURGEON MANUALLY REMOVED THE CORTICAL MATERIAL AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION WAS REC'D FROM THE SURGEON INDICATING AFTER THE SYSTEM MESSAGE WAS REC'D, THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO IMPACT 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 85 YR AMVISC