Events

Recall of Device Recall LipiFlow

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tearscience, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1535-2017
  • Event Initiated Date
    2017-01-30
  • Event Date Posted
    2017-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152977
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Eyelid thermal pulsation system - Product Code ORZ
  • Reason
    Labeling: the labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
  • Action
    Tearscience sent an MEDICAL DEVICE LABELING CORRECTION/RECALL letter dated January 30, 2017. .Actions to be Taken by Customer: Within 10 business days of receipt of this letter, please take the following actions: 1) Read the enclosed Summary of Important Labeling Changes for the LipiFlow¿ System. 2) Complete the Acknowledgement and Receipt form at www.TSVerify.pmcprograms.com or return the enclosed completed form by email or mail. 3) If you have stored Activators in an environment that is not temperature controlled (without heat and air conditioning), discontinue use of these Activators and call TearScience Labeling Change Hotline at (844) 872-5658. For any questions regarding this letter, please call (844) 872-5658 Monday through Friday, 8:00AM to 6:00PM, Eastern Time. We want to thank you for being a valuable TearScience partner, and as always would like to thank you for your business, your trust, and your commitment to treating MGD. For further questions please call (919) 459-4831.

Device

Device Recall LipiFlow
  • Model / Serial
    Model number LFD-1000 and LFD-1100, All lots
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide)
  • Product Description
    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
  • Manufacturer
    Tearscience, Inc

Manufacturer

Tearscience, Inc
  • Manufacturer Address
    Tearscience, Inc, 5151 McCrimmon Pkwy Ste 250, Morrisville NC 27560-5427
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA