BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2043073 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00282
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 24, 2011
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND PERFORMED PREVENTATIVE MAINTENANCE. NO SAMPLE IS EXPECTED TO RETURN. 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

    A CUSTOMER REPORTED THAT THE EQUIPMENT LOCKED THEN, TURNED OFF AND STOPPED WORKING WHEN IT WAS TURNED ON AGAIN DURING A PROCEDURE. THE SYSTEM WAS EXCHANGED WITH ANOTHER ONE TO COMPLETE THE SURGERY FOLLOWING A 20 MINUTE DELAY. ADDITIONAL INFO WAS RECEIVED. A SYSTEM MESSAGE DISPLAYED DURING A CATARACT EXTRACTION PROCEDURE. THE SYSTEM WAS RESET AND DID NOT TURN ON AGAIN. ADDITIONAL ANESTHESIA WAS GIVEN TO THE PT DURING THE SYSTEM SWITCH OUT AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO HARM OR INJURY TO THE PT.

    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