BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1854327 · Received September 30, 2010

    Report

    Report Number
    2028159-2010-01865
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 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
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF THE UNIT NOT RECOGNIZING THE HANDPIECE WAS CONFIRMED BASED ON THE FUNCTIONAL TESTING CONDUCTED BY THE TERRITORY MANAGER AND TESTING OF THE RETURNED SAMPLE. IT WAS FOUND THAT THE COMPONENT AT LOCATION U31 WAS NONCONFORMING. ONCE IT WAS REPLACED, THE RETURNED U/S CONTROLLER PCBA WAS INSTALLED INTO A CALIBRATED SYSTEM AND TESTED. THE PCBA PASSED BOTH TESTS. THE NONCONFORMING COMPONENT AT LOCATION U31 IS THE ROOT CAUSE FOR THE REPORTED ISSUE OF HANDPIECES NOT BEING RECOGNIZED BY THE SYSTEM, AS THE REPORTED EVENT WAS ADDRESSED AFTER REPLACEMENT OF THIS COMPONENT. THIS REPORT WAS MAILED TO FDA ON 12/22/2010. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    PT'S GENDER: UNK. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE PCB WAS REPLACED AND THE DISPLAY WAS RETIGHTENED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SYSTEM DOES NOT RECOGNIZE THE PHACO HANDPIECE. THE EVENT OCCURRED AS THE SURGEON COMPLETED THE SCULPT MODE AND WAS STARTING QUAD REMOVAL. THE HANDPIECE WAS SWITCHED OUT AND THE SAME ISSUE OCCURRED. THE SYSTEM WAS SWAPPED OUT TO COMPLETE THE CASE. THERE WAS A SLIGHT DELAY NOTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628251 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown