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TearCare System - TearCare SmartHub Kit
Sight Sciences, Inc. · Model FG 07392 · UDI-DI 00858027006457
ORZ
Prescription
1
510(k) clearances
37
Adverse events
3
Recalls
17
Facilities
Description
TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Sight Sciences, Inc. | 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 ev |
| 2017-01-30 | Tearscience, Inc | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. |
| 2016-09-13 | Tearscience, Inc | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. |
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