BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEMS OZIL

    MDR report key: 1880155 · Received October 15, 2010

    Report

    Report Number
    2028159-2010-02023
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 16, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE US CONTROLLER PCB WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM DID NOT RECOGNIZE THE HANDPIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM AS ANESTHESIA HAD ALREADY BEEN ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS ISSUE OCCURRED PRIOR TO SURGERY. THE HANDPIECES WERE SWITCHED TWICE BUT SYSTEM STILL WOULD NOT RECOGNIZE THE DEVICES. THE SYSTEM WAS THEN SWITCHED OUT AND THE SCHEDULED CASES WERE COMPLETED. THERE WAS A DELAY TO THE START OF SURGERY OF ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1