BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1033370 · Received April 24, 2008

    Report

    Report Number
    2028159-2008-00142
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE ERROR MESSAGE. THE IV POLE PCB WAS REPLACED AND SENT FOR IN-HOUSE TESTING. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 4/24/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE IV POLE WAS NOT WORKING AND THE STAFF HAD TO MOVE IT MANUALLY. AN ERROR MESSAGE DISPLAYED. THE CUSTOMER REPORTED THAT AN UNPLANNED VITRECTOMY WAS PERFORMED DUE TO A POSTERIOR CAPSULE TEAR. MULTIPLE ATTEMPTS WERE MADE FOR MORE INFO ON THE EVENT WITH NO RESPONSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S