Z-1001-2022Class II

TearCare version 1.0 SmartHubs

Name: Z-1001-2022 TearCare version 1.0 SmartHubs
Creator: Sight Sciences, Inc.
Published: 2022-03-23
License: https://open.fda.gov/license/

Sight Sciences, Inc. / initiated 2022-03-23 / Open, Classified

FDA source

Sight Sciences, Inc. began a recall of TearCare version 1.0 SmartHubs on 2022-03-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1001-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-23
Posted: 2022-04-25
Recalling firm: Sight Sciences, Inc.
Product: TearCare version 1.0 SmartHubs
Product code: ORZ Eyelid Thermal Pulsation System
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.
FDA 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1001-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-25

Product code ORZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)