BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1885106 · Received October 20, 2010

    Report

    Report Number
    2028159-2010-01986
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 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
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY BIOMEDICAL ENGINEER TESTED THE SYSTEM AND STATED IT FUNCTIONED FINE. THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THE SYSTEM SHUT DOWN DURING SURGERY. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. NO PATIENT 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