BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1832072 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01653
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Report Date
    August 6, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE TOUCHSCREEN WAS REPLACED AND RECALIBRATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCTION SPECIFICATIONS. THE TOUCHSCREEN HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S):" NO PT INJURY REPORTED" (NO CONSEQUENCE OR IMPACT TO PT). PRODUCT PROBLEM(S): "TOUCHSCREEN FROZE" (NO DISPLAY OR DISPLAY FAILURE). THE CUSTOMER REPORTED THE TOUCHSCREEN FROZE UP DURING SURGERY. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE AS PLANNED. NO PT INJURY WAS 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 UNK