BEUDAMED
    FDA Enforcement Class II Terminated

    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

    Recall: Z-0144-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0144-2014
    Event ID
    66040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Insight Instruments, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    June 27, 2013
    Classification Date
    November 4, 2013
    Termination Date
    September 27, 2017
    Address
    2580 Se Willoughby Blvd, N/A, Stuart, FL, 34994-4701, United States

    Description

    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

    Reason

    The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

    Code Info

    Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014

    Distribution

    Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.

    Quantity

    10212