BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1940065 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02433
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 23, 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
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE PROBLEM REPORTED. PREVENTIVE MAINTENANCE WAS PERFORMED, THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECS. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHILE PERFORMING AN ANTERIOR VITRECTOMY, THERE WAS VERY LOW TO NO ASPIRATION. THE SYSTEM WAS REPRIMED, BUT THE PROBLEM PERSISTED. THE FOOTSWITCH WAS SWITCHED OUT AND THE PROBE WAS FLUSHED, BUT STILL DID NOT FIX THE PROBLEM. THE SYSTEM AND THE PROBE WERE THEN SWITCHED OUT; HOWEVER, THE SAME RESULT OCCURRED. THE CASE WAS EVENTUALLY COMPLETED WITH THE SECOND SYSTEM. THE CASE WAS DELAYED 20-30 MINUTES WHILE TROUBLESHOOTING WAS PERFORMED AND SYSTEM WAS SWITCHED OUT. 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