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U.S. Department of Health and Human Services

Class 2 Device Recall Lipiflow Thermal Pulsation System

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  Class 2 Device Recall Lipiflow Thermal Pulsation System see related information
Date Initiated by Firm September 13, 2016
Date Posted October 17, 2016
Recall Status1 Terminated 3 on February 09, 2017
Recall Number Z-0093-2017
Recall Event ID 75163
510(K)Number K093937  K112704  K133127  
Product Classification Eyelid thermal pulsation system - Product Code ORZ
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.
Code Information Lot 201615220020
Recalling Firm/
Manufacturer		 Tearscience, Inc
5151 McCrimmon Pkwy Ste 250
Morrisville NC 27560-5427
For Additional Information Contact TearScience Customer Service
919-459-4891
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 1,200 Activators (120 boxes of 10 units)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ORZ and Original Applicant = TEARSCIENCE, INC.
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