BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2861329 · Received December 3, 2012

    Report

    Report Number
    MW5027941
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ALCON LABS, INC
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS IS ABOUT AN ALCON INFINITI. THE DEVICE GIVES AN ERROR CODE 135. THE UNIT WILL NOT FUNCTION WITH THIS ERROR. THIS CAUSED A DELAY OF THE CASE BUT FAILED BEFORE THE PT WAS IN THE ROOM. IN TALKING WITH THE MFR, THEY SAID THAT THEY WERE AWARE OF THE PROBLEM AND SOLD ME THE SPACER THAT FIXES IT. THEY SAID THIS NEEDS TO BE CHANGED AS PART OF THE PM PROGRAM. I HAVE THEIR PM PROCEDURE AND IT DOES NOT RECOMMEND THIS REPLACEMENT. I ASKED THE COMPANY IF I COULD GET A COPY OF THE NEW PROCEDURE AND WAS TOLD THAT THEY NO LONGER PROVIDE THAT. THE NEW SPACER IS VERY DIFFERENT FROM THE ORIGINAL AND IS DIRECTIONAL. I FEEL THAT THIS SHOULD HAVE BEEN A DEVICE ALERT AND CORRECTION TO THEIR DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACO HQC ALCON LABS, INC INFINITI VISION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other