BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1910074 · Received November 10, 2010

    Report

    Report Number
    2028159-2010-02170
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SETTINGS WERE RELOADED. THE STAFF REPORTED TO THE COMPANY SERVICE REP THAT THE FOOTSWITCH WAS NOT WORKING. THE FOOTSWITCH PCB WAS REPLACED AS A DIAGNOSTIC MEASURE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE FOOTSWITCH PCB HAS 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

    THE NURSE REPORTED THE SETTINGS WERE NOT CORRECT AND THE IRRIGATION WOULD NOT STOP. THE NURSE STATED THE IRRIGATION WOULD NOT STOP DURING SURGERY. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. THERE WAS A TEN MINUTE DELAY. NO PT INJURY WAS 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 UNK