BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 2061017 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00354
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOOTSWITCH HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/08/2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR MESSAGE. THE FOOTSWITCH WAS EXCHANGED AND THE CABLE WAS REPLACED. ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO, RECEIVED FROM CUSTOMER, INDICATED THIS EVENT OCCURRED DURING A PROCEDURE. THE PROCEDURE HAD JUST BEGAN AND THE LENS HAD NOT YET BEEN REMOVED WHEN THE CASE HAD TO BE ABORTED AND RESCHEDULED. THERE WAS NO HARM TO THE PT.

    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 Other INFINITI ENHANCED FOOTSWITCH| FOOTSWITCH CABLE INFINITI