BEUDAMED
    FDA Enforcement Class II 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 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1281-2013
    Event ID
    64887
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insight Instruments, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    March 15, 2013
    Classification Date
    May 10, 2013
    Termination Date
    August 21, 2014
    Address
    2580 Se Willoughby Blvd, Stuart, FL, 34994-4701, United States

    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.

    Code Info

    Lot Numbers: M53157, M55115, M56929, M58551, M61862.

    Distribution

    US Distribution IN and IL

    Quantity

    776