BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1063662 · Received June 19, 2008

    Report

    Report Number
    2028159-2008-00226
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE ERROR MESSAGE REPORTED. THE COMPANY SERVICE REP INDICATED THE PROBLEM WAS A SIMPLE CABLE COMMUNICATING BETWEEN THE HOST MODULE AND THE FLUIDICS MODULE. IT WAS WORKING INTERMITTENTLY. THE CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 36 MONTHS DID NOT INDICATE ANY ADDITIONAL REPORTS FOR THIS SYSTEM, NOR DID IT INDICATE ADVERSE TRENDS FOR THE REPORTED ISSUE. FURTHERMORE, A REVIEW OF THE SERVICE HISTORY FOR THIS SYSTEM DID NOT INDICATE ANY ADDITIONAL, RELATED UNPLANNED SERVICE REQUESTS, NOR DID IT INDICATE ADVERSE SERVICE TRENDS FOR THE REPORTED ISSUE. THIS REPORTED MAILED IN TO FDA ON 06/19/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR MESSAGE DISPLAYED WHILE PREPARING FOR THE FIFTH CASE OF THE DAY. THE CUSTOMER COULD NOT PROCEED WITH PRIMING THE HANDPIECE. THERE HAD BEEN ONE PATIENT PREPPED WHEN THIS EVENT OCCURRED; HOWEVER, THE CASE HAD NOT BEEN STARTED. THE CUSTOMER CANCELLED EIGHT CASES. THERE WAS NO PATIENT INJURY REPORTED.

    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