Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TearCare version 1.0 SmartHubs Recalled by Sight Sciences, Inc. Due to Ophthalmic devices distributed prior to the recently-obtained 510(k)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sight Sciences, Inc. directly.
Affected Products
TearCare version 1.0 SmartHubs
Quantity: 921
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sight Sciences, Inc.
Sight Sciences, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report