BEUDAMED
    FDA Recall Open, Classified

    TearCare version 1.0 SmartHubs

    Recall: Z-1001-2022 · Initiated March 23, 2022

    Recall

    Recall Number
    Z-1001-2022
    Event Number
    89939
    Firm
    Sight Sciences, Inc.
    FEI Number
    3010363671
    Product Code
    ORZ
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    March 23, 2022
    Address
    4040 Campbell Ave, Suite 100, Menlo Park, CA, 94025-1052

    Description

    TearCare version 1.0 SmartHubs

    Reason

    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.

    Action

    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 [email protected]

    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