medical Class II Updated 2022-05-04

Sight Sciences, Inc. recalls TearCare version 1.0 SmartHubs

Recalled Product

TearCare version 1.0 SmartHubs


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
View official government recall

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