BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1506-2013 · Initiated April 17, 2013

    Recall

    Recall Number
    Z-1506-2013
    Event Number
    65006
    Firm
    Alcon Grieshaber AG Winkelriedstrasse 52 Schaffhausen Switzerland
    FEI Number
    3003398873
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    April 17, 2013
    Posted
    June 6, 2013
    Terminated
    January 7, 2015

    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.

    Action

    Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.

    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