Z-0093-2017 Class II Terminated
FDA device recall Z-0093-2017 was initiated by Tearscience, Inc on September 13, 2016 and is designated Class II. 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. The recall status is terminated (terminated February 9, 2017). Affected quantity: 1,200 Activators (120 boxes of 10 units).
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- September 13, 2016
- Termination Date
- February 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,200 Activators (120 boxes of 10 units)
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.
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.
Code Information
Lot 201615220020