BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1940852 · Received December 17, 2010

    Report

    Report Number
    2028159-2010-02384
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    December 1, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SURGEON EXPERIENCED IRRIGATION/INFUSION ISSUES CAUSING A DELAY IN THE PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT PATIENT HARM OR INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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