BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTALLATION VISION SYSTEM

    MDR report key: 2861628 · Received November 29, 2012

    Report

    Report Number
    2028159-2012-01870
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED EVENT. THE COMPANY REP FOUND THAT THE FOOTSWITCH WAS NOT PROPERLY CONNECTED. THE FOOTSWITCH CABLE WAS RESEATED. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CAN BE ATTRIBUTED TO A LOOSE FOOTSWITCH CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE BI-POLAR CAUTERY WAS NOT WORKING. THE CASE WAS COMPLETED USING AN ALTERNATE CAUTERY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTALLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK