Reported May 4, 2022 · Ongoing
TearCare version 1.0 SmartHubs
Sight Sciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sight Sciences, Inc. · 4040 Campbell Ave · Menlo Park, CA · 94025-1052
Is this the product you have?
- TearCare version 1.0 SmartHubs
- Lot codes and dates
- UDI/DI00858027006273
- Lots
1007076 through 1007406133914 through 137646and 846004203 through 846237811
- Amount recalled
- 921
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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