Events

Recall of Lipiflow Thermal Pulsation System

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
    75163
  • Event Risk Class
    Class 2
  • Event Number
    Z-0093-2017
  • Event Initiated Date
    2016-09-13
  • Event Date Posted
    2016-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149494
  • 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
    Complaints related to an error condition occurring during patient treatment where the fipiflow system automatically stopped treatment after detecting a problem with the activator.
  • Action
    The firm, TearScience, sent a "Medical Device Recall" letter dated September 9, 2016 to its consignees/customers on 9/13/2016. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email to: Customerservice@tearscience.com or mail to TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement. For any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.

Device

Lipiflow Thermal Pulsation System
  • Model / Serial
    Lot 201615220020
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • 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