BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3834527 · Received March 19, 2014

    Report

    Report Number
    2028159-2014-00443
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 17, 2014
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A SAMPLE IS NOT EXPECTED AS THE HANDPIECES HAVE BEEN PUT BACK INTO CIRCULATION. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED "OCCLUSIONS ISSUES" DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE IN FOUR OUT OF THE FIVE PTS. THE HANDPIECE WAS EXCHANGED TO COMPLETE SURGERY WITH NO HARM TO THE PTS. THE OPERATING ROOM MGR SUSPECTS THAT THE HANDPIECES ARE NOT BEING FLUSHED AFTER THE PROCEDURE. THE OPERATING ROOM MGR REMINDED THE STAFF THAT THEY NEED TO FLUSH THE HANDPIECES PRIOR TO SENDING THEM FOR STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163303 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECH CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OZIL TORSIONAL PHACO HANDPIECE