BEUDAMED
    FDA Enforcement Class II Terminated

    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

    Recall: Z-0093-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0093-2017
    Event ID
    75163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tearscience, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    September 13, 2016
    Classification Date
    October 17, 2016
    Termination Date
    February 9, 2017
    Address
    5151 McCrimmon Pkwy Ste 250, N/A, Morrisville, NC, 27560-5427, United States

    Description

    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

    Reason

    Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.

    Code Info

    Lot 201615220020

    Distribution

    US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.

    Quantity

    1,200 Activators (120 boxes of 10 units)