BEUDAMED
    FDA Recall Terminated

    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

    Recall: Z-1281-2013 · Initiated March 15, 2013

    Recall

    Recall Number
    Z-1281-2013
    Event Number
    64887
    Firm
    Insight Instruments, Inc.
    FEI Number
    1052234
    Product Code
    HMX
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 15, 2013
    Posted
    May 10, 2013
    Terminated
    August 21, 2014
    Address
    2580 Se Willoughby Blvd, Stuart, FL, 34994-4701

    Description

    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.

    Reason

    Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.

    Action

    Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.

    Distribution

    US Distribution IN and IL

    Quantity

    776