BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1992849 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00070
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. ACTIONS TAKEN: NO ACTION IS PLANNED AT THIS TIME. 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

    THE CUSTOMER REPORTED MULTIPLE SYSTEM MESSAGES DURING THE PROCEDURE, AS PRECAUTION THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. NO PT HARM / INJURY WAS REPORTED. ADDITIONAL INFO WAS 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