BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2020625 · Received February 10, 2011

    Report

    Report Number
    2028159-2011-00105
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED SYSTEM MESSAGE. THE FLUIDICS MECHANISM ASSEMBLY (FMA) WAS REPLACED TO CORRECT THE PROBLEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE FMA IS EXPECTED TO RETURN FOR IN-HOUSE EVAL. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4) [COMPONENT CODE(S)]. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING CATARACT SURGERY, THE SYSTEM DISPLAYED A MESSAGE. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED WITHOUT ANY DELAY OR HARM 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 UNK