TearCare version 1.0 SmartHubs

Company

Sight Sciences, Inc.

Recall Initiated

March 23, 2022

Recall Number

Z-1001-2022

Quantity

921

Firm Location

Menlo Park, CA

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.

Lot / Code Info

UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.

Root Cause

No Marketing Application

Action Taken

On 03/23/22, recall notices were mailed to customers who were informed that the recalling firm intends to send new 510(k)-cleared devices, version 1.5, to replace affected devices. Customers were asked to do the following: 1) After receiving the new devices, return the affected devices to the recalling firm. 2) Complete and return the response form. Customers questions can contact customer service at: 877-266-1144 or TearCareContactUs@sightsciences.com