BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1003583 · Received February 20, 2008

    Report

    Report Number
    2028159-2008-00065
    Event Type
    Death
    Date Received
    February 20, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER SERVICE REP EXAMINED THE SYSTEM ON THE SAME DAY AND FOUND NO ISSUES WITH THE SYSTEM, HANDPIECE, OR FOOTSWITCH. THE SYSTEM WAS CHECKED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINT DATA FOR THE SYSTEM INDICATES THAT THERE HAVE BEEN NO ADD'L COMPLAINTS RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED CORNEAL BURN IS UNK AND CANNOT BE DETERMINED BECAUSE NO SAMPLE WAS RETURNED FOR ROOT CAUSE ANALYSIS, AND THE REPORTED SYSTEM MET ALCON SPECIFICATIONS WHEN SERVICED BY AN ALCON TECHNICIAN. THE RISK MANAGEMENT REPORT WAS REVIEWED AND THE POTENTIAL HAZARDS ASSOCIATED WITH THIS USE OF THE SYSTEM HAVE BEEN ANALYZED AND MANAGED IN SUCH A WAY THAT ALL ASSOCIATED RISKS HAVE BEEN REDUCED TO ACCEPTABLE LEVELS FOR THERMAL INJURY. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ECRI HEALTH DEVICES, HAZARD UPDATE; SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, 1996, VOL 25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER. THIS REPORT MAILED IN TO FDA ON: 02/20/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE FOURTH CASE OF THE DAY A CORNEAL BURN OCCURRED. NO PT INTERVENTION HAS BEEN REPORTED. TWO SUBSEQUENT CASES WERE ABLE TO BE COMPLETED WITH NO ISSUES. NO FURTHER INFO HAS BEEN RECEIVED.

    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