# FDA recall Z-1001-2022

> **Sight Sciences, Inc.** · Class II · device recall initiated 2022-03-23.

## Product

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

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.

## Key facts

- **Recall number:** Z-1001-2022
- **Recalling firm:** Sight Sciences, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-23
- **Report date:** 2022-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Menlo Park, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2022

## Citation

> AI Analytics. FDA recall Z-1001-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1001-2022. Source: US FDA. Licensed CC0.

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