Recall Z-0093-2017— Tearscience, Inc
Class II · Terminated
Class II FDA medical device recall by Tearscience, Inc, initiated 2016-09-13, terminated 2017-02-09. It names 2 FDA 510(k) clearances: K133127, K112704. Product: 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..
- Recalling firm
- Tearscience, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-13
- Terminated
- 2017-02-09
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.