Sight Sciences recalls TearCare version 1.0 SmartHubs sold without FDA 510(k) clearance. These ophthalmic devices may not meet safety standards due to untested performance.
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.
Sight Sciences is recalling TearCare version 1.0 SmartHubs that were distributed before receiving FDA 510(k) clearance. This means the devices' safety wasn't evaluated by the FDA prior to being sold, potentially putting users at risk.
The FDA requires ophthalmic devices to undergo 510(k) clearance before distribution to ensure safety. These devices were sold without this clearance, meaning their performance characteristics weren't evaluated for safety risks.
Users of TearCare version 1.0 SmartHubs who purchased them between specific production lots are affected. People using these devices for eye care are most at risk due to untested safety features.
Check the product's UDI/DI number (00858027006273) and production lots (1007076 through 1007406, 133914 through 137646, or 846004203 through 846237811) to identify recalled units.
Identify your TearCare version 1.0 SmartHubs using the UDI/DI number and production lots listed in the recall notice.
The FDA requires ophthalmic devices to undergo 510(k) clearance before distribution. These devices were sold without this clearance, so their safety wasn't evaluated.
Check the product's UDI/DI number (00858027006273) and production lots (1007076 through 1007406, 133914 through 137646, or 846004203 through 846237811).
The recall notice does not specify a remedy or action for affected users.
We’ve drafted a message you can send Sight Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1001-2022 — Sight Sciences Sight Sciences Hello, I own a Sight Sciences that is covered by recall Z-1001-2022 from Sight Sciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
