BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1243152 · Received November 21, 2008

    Report

    Report Number
    2028159-2008-00424
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 24, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND DID NOT DUPLICATE THE SYSTEM MESSAGE REPORTED. THE SYSTEMS WERE THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE STAFF DID NOT SAVE THE CONSUMABLES FOR EVALUATION AND THE COMPANY SERVICE REPRESENTATIVE COUNSELED THE STAFF TO SAVE ANY CONSUMABLES FOR EVALUATION IF THE INCIDENT RECURS. THE COMPANY SERVICE REPRESENTATIVE RE INSERVICED THE STAFF ON THE SYSTEM, INCLUDING SET-UP AND TROUBLESHOOTING. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT AN OCCLUSION SYSTEM MESSAGE DISPLAYED DURING SURGERY. THEY ATTEMPTED TO RESOLVE THE ISSUE BY RE-BOOTING, SWITCHED OUT THE HANDPIECES, AND ALL CONSUMABLES. THEY ALSO BROUGHT IN ANOTHER SYSTEM; HOWEVER, THE SECOND UNIT ALSO DISPLAYED THE SAME MESSAGE. THEY WERE UNABLE TO COMPLETE THE CASE AND 4 OTHER CASES WERE CANCELLED. THERE WAS NO PATIENT HARM REPORTED.

    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 Required Intervention