Tearscience, Inc: Medical Device Recall in 2016 - (Recall #: Z-0093-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 13, 2016

Date Posted: October 26, 2016

Recall Number: Z-0093-2017

Event ID: 75163

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,200 Activators (120 boxes of 10 units)

Code Information:

Lot 201615220020

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated