TearCare version 1.0 SmartHubs
Check against the official notice below — it lists the full affected range.
Sight Sciences, Inc. is recalling 921 TearCare version 1.0 SmartHubs that were distributed nationwide across 44 states and Washington, D.C. The devices were distributed before the company obtained FDA 510(k) clearance, meaning the FDA had not evaluated their performance characteristics prior to distribution. The affected devices are identified by UDI/DI number 00858027006273 and specific lot codes ranging from 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
The recall notice does not specify a remedy or recommended course of action for consumers who may have received these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE. Quantity: 921 Lot/code info: UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.