BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1930349 · Received November 18, 2010

    Report

    Report Number
    2028159-2010-02247
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED PROBLEM. A BAD PORT WAS FOUND ON THE FOOTSWITCH INTERFACE PCB. THE FOOTSWITCH INTERFACE PCB WAS REPLACED AND WILL BE SENT FOR IN-HOUSE EVAL. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. 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 CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE, DURING SETUP, INDICATING THE FOOTSWITCH COULD NOT BE DETECTED. THE CASE WAS DELAYED 15 MINUTES WHILE THEY SWAPPED THE FOOTSWITCHES. THERE WAS NO PT INJURY REPORTED.

    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