BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1940469 · Received December 17, 2010

    Report

    Report Number
    2028159-2010-02411
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED EVENTS FOLLOWING EXAMINATION OF BOTH UNITS AND REMOTE CONTROLS. THE SYSTEMS MET ALL PRODUCT SPECIFICATIONS. THE REMOTES WERE REPLACED AND PRODUCT INFO WAS PROVIDED TO THE CUSTOMER. A SAMPLE IS EXPECTED TO RETURN FOR IN-HOUSE EVAL. 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 NURSE REPORTED SYSTEM CHANGED MODE AND SETTINGS ON IT'S OWN DURING SET UP OF A PROCEDURE. THE REMOVE CONTROL BUTTONS FOR THE UNIT WERE OBSERVED NOT WORKING PROPERLY. THE SYSTEM WAS SWITCHED OUT AND A SIMILAR ISSUE WAS NOTED WITH THE REMOTE AND REPLACEMENT UNIT. THE PROCEDURE WAS CANCELED AFTER THE PT HAD RECEIVED ANESTHESIA. THERE WAS NO PT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1