Sight Sciences, Inc. Recall 89939
Description: TearCare version 1.0 SmartHubs
Sight Sciences, Inc. Recall 89939 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1001-2022 |
| Event ID | 89939 |
| Event Description | TearCare version 1.0 SmartHubs |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20220504 |
| Device Code Info | UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811. |
| Center Classification Date | 20220425 |
| Recall Initiation Date | 20220323 |
| Recalling Firm | Sight Sciences, Inc. |
| Initial Notification | Letter |
| Similar To |