BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2030943 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00196
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 2, 2011
    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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND A SYSTEM MESSAGE - PNEUMATICS MECHANISM TIMEOUT IN THE EVENT LOG. THE MANIFOLD ASSEMBLY AND THE CABLE WERE REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. (B)(4) (DEVICE OPERATIONAL ISSUE). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A VITRECTOMY AND SECONDARY INTRAOCULAR LENS IMPLANT SURGERY, THE SYSTEM DISPLAYED A MESSAGE, THE PRESSURE WENT LOW, AND A STRANGE GAS NOISE WAS HEARD. THE SYSTEM WAS REBOOTED AND THE IRRIGATION AND ASPIRATION STARTED WORKING AGAIN; HOWEVER, THE VITRECTOMY DID NOT WORK. THE SURGEON USED THE IRRIGATION AND ASPIRATION MODE TO PERFORM THE VITRECTOMY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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