Sight Sciences, Inc. TearCare version 1.0 SmartHubs Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TearCare version 1.0 SmartHubs
Brand
Sight Sciences, Inc.
Lot Codes / Batch Numbers
UDI/DI: 00858027006273, Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Products Sold
UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Sight Sciences, Inc. is recalling TearCare version 1.0 SmartHubs due to Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performan. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026