Recall Z-1001-2022— Sight Sciences, Inc.
Class II · Ongoing
Class II FDA medical device recall by Sight Sciences, Inc., initiated 2022-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: TearCare version 1.0 SmartHubs. Reason: 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..
- Recalling firm
- Sight Sciences, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-23
- Firm location
- Menlo Park, CA, United States
Product description
TearCare version 1.0 SmartHubs
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.