BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1051481 · Received May 21, 2008

    Report

    Report Number
    2028159-2008-00180
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. THE SERIAL NUMBER OF THE HANDPIECE ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED; THEREFORE THE DATE OF MANUFACTURE AND TREND REVIEW FOR THIS PARTICULAR HANDPIECE COULD NOT BE CONDUCTED. A REVIEW OF COMPLAINTS FOR THE LAST 36 MONTHS DID NOT INDICATE THERE HAVE BEEN ADVERSE TRENDS FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 7 MICROSCOPIC (TINY METALLIC DOTS) FRAGMENTS WERE IN THE CORNEA. THE SURGEON ADVISED THAT THE FRAGMENTS COULD NOT BE REMOVED, AND DESCRIBED THEM AS "BRIGHT, SHINY FRAGMENTS." THE PT'S VISION WAS NOT AFFECTED AND THERE WAS NO PT INJURY. THE PT NOW NEEDS TO UNDERGO AN MRI AND IS SEEKING ADVICE ON WHETHER THIS IS POSSIBLE. ALCON HAS DETERMINED THAT THE TITANIUM IS INERT AND THAT THE SURGICAL STAINLESS STEEL USED IN OUR HANDPIECES WOULD NOT AFFECT AN MRI. THE CUSTOMER REPORTED THAT THEY CLEAN THE INSTRUMENTS PER THE ALCON "GUIDELINES" AND THEY DO NOT REUSE SINGLE-USE PHACO TIPS. THE DOCTOR DOES, HOWEVER, USE A TWO-HANDED TECHNIQUE, AND THE HANDPIECE WAS NOT REFURBISHED OR THIRD PARTY REPAIRED.

    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 76 YR