BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1840760 · Received September 17, 2010

    Report

    Report Number
    2028159-2010-01787
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    August 19, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE SYSTEM KEPT DISPLAYING A SYSTEM MESSAGE WHILE IN PHACO MODE. THE NURSE REPLACED THE HANDPIECE, TIP, AND CASSETTE WITHOUT A CHANGE IN RESULTS. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS A 15 MINUTE 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