BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1910071 · Received November 10, 2010

    Report

    Report Number
    2028159-2010-02162
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND TESTED ALL THE HANDPIECES. NO PROBLEMS WERE FOUND. THE COMPANY SERVICE REP ATTEMPTED TO DUPLICATE THE INTERMITTENT TOUCHSCREEN AND FOOTSWITCH ISSUE. THE PROBLEM COULD NOT BE DUPLICATED. THE TOUCHSCREEN AND FOOTSWITCH CABLE WERE REPLACED AS A DIAGNOSTIC MEASURE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE TOUCHSCREEN AND FOOTSWITCH CABLE 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

    THE CUSTOMER INITIALLY REPORTED NO PHACO POWER. THE CUSTOMER THEN REPORTED THE TOUCHSCREEN AND FOOTSWITCH INTERMITTENTLY DO NOT RESPOND. THE INTERMITTENT ISSUE OCCURS FIRST THING IN THE MORNING. ADDITIONAL INFO FROM THE NURSE STATED THE ISSUE WAS A FOOTSWITCH AND TOUCHSCREEN PROBLEM. THE CUSTOMER REPORTED A TEN MINUTE DELAY WHILE TROUBLESHOOTING THE ISSUE. THE CASES WERE COMPLETED WITH THE SYSTEM. NO CONSUMABLES WERE SAVED FOR EVAL. 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