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Sight Sciences, Inc. recalls TearCare version 1.0 SmartHubs
Recalled May 4, 2022 · FDA recall Z-1001-2022 · Sight Sciences
Hazard
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. · FDA Class II
Units
921
Sold at
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.
Description
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.
Product
TearCare version 1.0 SmartHubs
Manufacturer(s)
Sight Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →