BEUDAMED
    FDA Recall 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 · Initiated June 27, 2013

    Recall

    Recall Number
    Z-0144-2014
    Event Number
    66040
    Firm
    Insight Instruments, Inc.
    FEI Number
    1052234
    Product Code
    HNJ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 27, 2013
    Posted
    November 4, 2013
    Terminated
    September 27, 2017
    Address
    2580 Se Willoughby Blvd, Stuart, FL, 34994-4701

    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.

    Action

    Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393.

    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