BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1140652 · Received August 28, 2008

    Report

    Report Number
    2028159-2008-00312
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE FOOTSWITCH AND FOUND DEBRIS UNDER THE HEEL PLATE. UNABLE TO REMOVE ALL THE DEBRIS, THE FOOTSWITCH WAS REPLACED AND SENT FOR IN HOUSE TESTING. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE FAILED DURING THE I/A (IRRIGATION/ASPIRATION) STAGE, WHILE REMOVING VISCOELASTIC. ASPIRATION WAS COMPLETED MANUALLY USING TWO SYRINGES AND AN IRRIGATING SIMCO CANNULA, DURING THE LENS INSERTION STAGE. SURGERY WAS COMPLETED, BUT DELAYED BY APPROXIMATELY 10 MINUTES. THE HOSPITAL REPORTS THIS PATIENT'S PROGNOSIS IS GOOD. A SECOND PATIENT AWAITING SURGERY HAD RECEIVED TOPICAL ANESTHESIA, BUT THE PATIENT WAS RETURNED TO THE WARD AND THE OPERATION WAS CANCELLED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SURGEON SUSPECTED THE FOOTSWITCH, BECAUSE NOTHING HAPPENED WHEN PRESSING THE PEDAL.

    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 88 YR PROVISC