BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1854121 · Received September 2, 2010

    Report

    Report Number
    2028159-2010-01669
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE IRRIGATION PRESSURE SENSOR WAS REPLACED. SYSTEM CALIBRATION/OPERATION WAS CONFIRMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SAMPLE 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

    ADVERSE EVENT(S): "NO PT INVOLVEMENT" (NO PT INVOLVEMENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A NURSE REPORTED THE SYSTEM WOULD NOT ACCEPT CASSETTE CONSISTENTLY. A SYSTEM MESSAGE WAS ALSO DISPLAYED. THIS EVENT OCCURRED AT THE STARTUP PROCESS. THE CASSETTE WAS EJECTED AND REINSERTED BUT THE ISSUE PERSISTED. THE SYSTEM WAS REBOOTED, THE CASSETTE WAS REINSERTED AND PROCEEDED WITH ALL SCHEDULED CASES. THERE WAS A 25 MINUTE DELAY. THERE WAS NO PT IN THE ROOM AT THE TIME OF THE EVENT. THE CASSETTE WAS NOT SAVED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1