BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1842606 · Received September 1, 2010

    Report

    Report Number
    2028159-2010-01635
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 2, 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
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE CUSTOMER REPORTED THAT THEY SETUP FOR THE VITRECTOMY SURGERY USING THE SETUP MENU. THE CUSTOMER REQUESTED THAT THE SERVICE REPRESENTATIVE DISABLE THE SETUP MENU IN THE DOCTOR'S SETTINGS. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "IRRIGATION AND ASPIRATION POOR" (ASPIRATION ISSUE); "IRRIGATION AND ASPIRATION POOR" (INABILITY TO IRRIGATE). A NURSE REPORTED THE IRRIGATION AND ASPIRATION WAS POOR DURING A CASE. THE UNIT WAS SWITCHED OUT, THE SAME HANDPIECE WAS CONNECTED, AND THE CASE WAS COMPLETED WITHOUT DELAY. THERE WAS NO PATIENT 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