BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1003584 · Received February 20, 2008

    Report

    Report Number
    2028159-2008-00066
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Report Date
    January 21, 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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SERVICE REP EXAMINED THE SYSTEM AND NO PROBLEM WAS FOUND. THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. 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, NOVEMBER 1996, VOL. 25, NO. 11-426-431, 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 SERVICE REP WAS ON SITE FOR A SERVICE CALL AND HE WAS TOLD ABOUT A CORNEAL BURN THAT OCCURRED ONE MONTH AGO. THE CUSTOMER CONFIRMED THERE HAD BEEN A BURN; HOWEVER, SHE DID NOT REMEMBER MUCH ABOUT IT AND THEREFORE, DID NOT WISH TO COMPLETE A QUESTIONAIRE. THE CUSTOMER REQUESTED THE SURGEON BE CONTACTED FOR INFO ON THE EVENT. MULTIPLE ATTEMPTS WERE MADE WITH NO FURTHER INFO 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