BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2101746 · Received May 10, 2011

    Report

    Report Number
    2028159-2011-00485
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 11, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE ULTRASONIC (U/S) HANDPIECE CABLE. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A CATARACT EXTRACTION PROCEDURE THE HANDPIECE STOPPED WORKING. THE HANDPIECE WAS EXCHANGED TO COMPLETE THE CASE FOLLOWING A 20 MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE HANDPIECE WAS RE-TURNED TWICE AND DID NOT WORK THE SECOND TIME. THERE WAS NO HARM TO THE PATIENT.

    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