BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1243158 · Received November 21, 2008

    Report

    Report Number
    2028159-2008-00419
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SINGLE USE CASSETTE HAD BEEN RE-USED TWICE. THE CASSETTE WAS RECEIVED FOR IN HOUSE TESTING AND PASSED FUNCTIONAL TESTING. THE ROOT CAUSE OF THE PATIENT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY IS WITHIN KNOWN LEVELS FOR THIS EVENT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING THE IRRIGATION FLOW DECREASED RAPIDLY WITH THE ANTERIOR CHAMBER COLLAPSING AND A POSTERIOR CAPSULE TEAR OCCURRED. THE SURGEON THEN CONVERTED TO I/A AND THEN A SYSTEM MESSAGE DISPLAYED. THE CUSTOMER STATED THERE WAS NO PROBLEM FOUND WITH THE SYSTEM. THE CASSETTE WAS REPLACED AND THE SURGERY WAS COMPLETED. THE CUSTOMER STATED NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability