Recall Z-1001-2022 ยท ORZ Eyelid Thermal Pulsation System
Sight Sciences, Inc.
TearCare version 1.0 SmartHubs
| Date | Mar 23, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | No Marketing Application |
| 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 TearCareContactUs@sightsciences.com |
| Quantity | 921 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.