BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSSTEM OZIL

    MDR report key: 2913479 · Received January 9, 2013

    Report

    Report Number
    2028159-2013-00028
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. 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

    A SURGEON REPORTED THAT THE IRRIGATION TUBE WAS BENT APPROXIMATELY 2 CM FROM THE WHITE LUER CONNECTION PLUG WHEN IT WAS REMOVED FROM THE PACKAGING. THE TUBING SYSTEM PASSED FUNCTIONAL TESTING. THE PROCEDURE WAS UNEVENTFUL UNTIL THE TUBES WERE SWITCHED TO BIMANUAL I/A (IRRIGATION/ASPIRATION) HANDPIECES; THE IRRIGATION TUBE THEN BENT SINCE IT WAS NOT SUPPORTED BY THE ASPIRATION TUBE ANY LONGER. AS A RESULT, THE IRRIGATION FLOW TO THE EYE WAS IMPEDED. THE SURGEON RECOGNIZED THIS BEFORE THE IRRIGATION ON HANDPIECE WAS INSERTED IN THE EYE. THE NURSE SUPPORTED THE TUBE WITH BY HAND FOR THE REMAINDER OF THE PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED WITHOUT DELAY OR FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12938 INFINITI VISION SYSSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK| ULTRASONIC INFUSION PAK 0.9MM