BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1230407 · Received November 7, 2008

    Report

    Report Number
    2028159-2008-00399
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT CONFIRM THE COMPLAINT. THE FOOTSWITCH OPERATION WAS NORMAL DURING TESTING. THE FOOTSWITCH INTERFACE PCB WAS REPLACED AS A DIAGNOSTIC PURPOSE AND SENT FOR IN HOUSE TESTING. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 11/07/2008.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE FOOTSWITCH WAS NOT RECOGNIZED BY THE SYSTEM. THE FIRST CASE WAS COMPLETED WITH DIFFICULTY. THEY HAD TO DISCONNECT THE FOOTSWITCH CABLE AND RECONNECT IT IN ORDER TO COMPLETE THE CASE. THE FOUR FOLLOWING CASES WERE CANCELLED. NO PATIENT HARM WAS REPORTED. THE SURGEON STATED THE PATIENT OUTCOME WAS GOOD.

    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 78 YR INTRACAMERAL LIDOCAINE