Sight Sciences, Inc. recalls TearCare version 1.0 SmartHubs

Recall date

March 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1001-2022

FDA classification

Class II

Brand / firm

Sight Sciences, Inc.

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TearCare version 1.0 SmartHubs