BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1202834 · Received October 17, 2008

    Report

    Report Number
    2028159-2008-00379
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 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
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM, AND THE HANDPIECE FOR OCCLUSIONS OR CLOGGING, BUT THERE WERE NO PROBLEMS FOUND. THEN THE SYSTEM WAS TESTED AND IT 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.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A THERMAL INJURY. THE SURGEON STATED THAT DURING CATARACT SURGERY, HE NOTICED THE INCISION AREA HAD FISH MOUTHED DUE TO THE BURN. THE WOUND WAS SUTURED CLOSED WITH ONE STITCH. THE PT IS DOING FINE. ADDITIONAL INFO RECEIVED FROM THE NURSE STATES THE SURGEON NOTED THE HANDPIECE MUST HAVE BEEN PARTIALLY OCCLUDED BEFORE SURGERY. THE NURSE STATED THE SYSTEM WAS TESTED PRIOR TO SURGERY AND THE HANDPIECE PRIMED AND TUNED WITH NO PROBLEMS OR SYSTEM MESSAGES. AN OCCLUSION SYSTEM MESSAGE WAS HEARD WHEN THE EVENT OCCURRED AND CHAMBER INSTABILITY WAS NOTED WITH THE CHAMBER NOT RECOVERING. A NEW PHACO TIP AND HANDPIECE WERE USED TO COMPLETE THE CASE.

    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 Required Intervention DUOVISC