BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1834398 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01727
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. NO ADVISORIES RELATING TO ASPIRATION, VACUUM, OR FLOW WERE FOUND IN THE ERROR LOG. THE REPRESENTATIVE PERFORMED A FLUIDICS DRY TEST, ASPIRATION FLOW TEST, AND OCCLUSION TEST. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "DECREASED ASPIRATION DURING I/A" (ASPIRATION ISSUE). A BIOMEDICAL ENGINEER REPORTED PROBLEMS WITH ASPIRATION DURING IRRIGATION/ASPIRATION (I/A). ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO WAS RECEIVED: THE NURSE MANAGER REPORTED THE ASPIRATION WAS NOT AS STRONG AS USUAL. THE SURGEON WAS OFFERED ANOTHER HANDPIECE, BUT HE STATED IT WAS NOT NECESSARY AS HE WOULD BE ABLE TO FINISH THE CASE. THE CASE WAS COMPLETED, BUT THE FOLLOWING TWO CASES WERE CANCELED AS A PRECAUTION. THERE WAS NO PT INJURY 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