BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2241428 · Received August 18, 2011

    Report

    Report Number
    2028159-2011-00976
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE TO ADDRESS THE CUSTOMER REPORTED PROBLEM. DURING TESTINGS OF THE ULTRASONICS (U/S), THE COMPANY REP REC'D A SYSTEM MESSAGE "COMMAND FAILURE TUNING: FREQUENCY ORDER". THE U/S CONTROLLER PRINTED CIRCUIT BOARD (PCB) WAS REPLACED TO ADDRESS THIS ISSUE. THE FOOTSWITCH CABLE WAS ALSO REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SAMPLE HAS BEEN REC'D AND IN-HOUSE EVAL IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT MULTIPLE SYSTEM ERRORS DISPLAYED DURING A PROCEDURE. AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE CASE FOLLOWING A 15 MIN DELAY. THERE WAS NO PT HARM. ADD'L INFO HAS BEEN REQUESTED.

    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