BEUDAMED
    FDA Enforcement Class II Ongoing

    TearCare version 1.0 SmartHubs

    Recall: Z-1001-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1001-2022
    Event ID
    89939
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sight Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2022
    Initiation Date
    March 23, 2022
    Classification Date
    April 25, 2022
    Address
    4040 Campbell Ave, Suite 100, Menlo Park, CA, 94025-1052, United States

    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.

    Code Info

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

    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