BEUDAMED
    FDA Enforcement Class II Terminated

    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

    Recall: Z-1506-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1506-2013
    Event ID
    65006
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Grieshaber AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 17, 2013
    Classification Date
    June 6, 2013
    Termination Date
    January 7, 2015
    Address
    Winkelriedstrasse 52, N/A, Schaffhausen, N/A, N/A, Switzerland

    Description

    The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.

    Reason

    Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.

    Code Info

    All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01

    Distribution

    Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.

    Quantity

    8,455 units