BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1940119 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02439
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE BEZEL AND TOUCH SCREEN WAS REPLACED FOR DIAGNOSTIC PURPOSES. UNIT MET ALL PRODUCT SPECS. A SAMPLE IS EXPECTED TO RETURN FOR IN-HOUSE EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE TOUCHSCREEN LOCKED DURING A PROCEDURE. THE SYSTEM WAS EXCHANGED TO CONCLUDE THE SURGERY. NO PT INJURY OR HARM REPORTED.

    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