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U.S. Department of Health and Human Services

Class 2 Device Recall TearCare SmartHub

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  Class 2 Device Recall TearCare SmartHub see related information
Date Initiated by Firm March 23, 2022
Create Date April 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-1001-2022
Recall Event ID 89939
Product Classification Eyelid thermal pulsation system - Product Code ORZ
Product TearCare version 1.0 SmartHubs
Code Information UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Recalling Firm/
Manufacturer		 Sight Sciences, Inc.
4040 Campbell Ave
Suite 100
Menlo Park CA 94025-1052
Manufacturer Reason
for Recall		 Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
FDA Determined
Cause 2		 No Marketing Application
Action On 03/23/22, recall notices were mailed to customers who were informed that the recalling firm intends to send new 510(k)-cleared devices, version 1.5, to replace affected devices. Customers were asked to do the following: 1) After receiving the new devices, return the affected devices to the recalling firm. 2) Complete and return the response form. Customers questions can contact customer service at: 877-266-1144 or TearCareContactUs@sightsciences.com
Quantity in Commerce 921
Distribution US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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