LipiFlow thermal Pulsation System recalled over fire hazard

Recall date

September 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Tearscience, Inc recalls LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation S…

Recall number

Z-0093-2017

FDA classification

Class II

Brand / firm

Tearscience, Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.