BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1062046 · Received June 13, 2008

    Report

    Report Number
    2028159-2008-00222
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT, SERVICE, AND MANUFACTURING HISTORY DATA FOR THE SYSTEM INDICATES THAT THERE HAS BEEN NO ADDITIONAL COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. COMPLAINT TRENDING INDICATES NO RECENT ADVERSE TRENDS. NO SAMPLE WAS RETURNED, AND THE CUSTOMER DID NOT REQUEST A SYSTEM EVAL. THE ROOT CAUSE OF THE VENT CANNOT BE DETERMINED BECAUSE INSUFFICIENT INFO WAS PROVIDED BY THE CUSTOMER. 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 COMPANY SALES REPRESENTATIVE WAS PRESENT AT THIS SURGERY AND STATED THAT THE OCCLUSION BELL WENT OFF, BUT THE SURGEON WAS UNABLE TO AVOID BURNING THE CORNEA. PATIENT STATUS IS UNKNOWN. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN REC'D TO DATE.

    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