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.
- Product
- TearCare version 1.0 SmartHubs
- Category
- Medical Device
- Distribution
- Distributed nationwide