Z-1001-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- March 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 921
Product Description
TearCare version 1.0 SmartHubs
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 Pattern
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.
Code Information
UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.