TearCare Version 1.0 SmartHubs Recalled for Lack of FDA Premarket Evaluation
Sight Sciences is recalling 921 TearCare version 1.0 SmartHubs ophthalmic devices distributed nationwide because they were distributed prior to FDA 510(k) clearance without premarket evaluation of their performance characteristics.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for ophthalmic devices distributed without FDA premarket evaluation of performance characteristics. While no adverse events have been reported, these unvalidated eye devices present a theoretical but significant risk due to lack of regulatory performance assessment.
Plain-English summary
Sight Sciences, Inc. is recalling 921 TearCare version 1.0 SmartHubs, ophthalmic devices distributed nationwide across 43 states and Washington D.C. The recalled devices are identified by lot codes: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
These devices were distributed prior to obtaining FDA 510(k) clearance and therefore do not fall within the applicable 510(k) exemption. Their performance characteristics were not evaluated by the FDA before distribution. FDA has classified this as a Class II recall.
Patients and healthcare providers who have received or are using these devices should contact Sight Sciences, Inc. or consult the FDA for guidance on the appropriate course of action.
The recalled product
- Product
- TearCare version 1.0 SmartHubs
- Manufacturer
- Sight Sciences, Inc.
- Affected units
- 921
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI: 00858027006273
- Lots: 1007076 through 1007406
- 133914 through 137646
- and 846004203 through 846237811.
Distribution
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