Sight Sciences, Inc. recalls TearCare version 1.0 SmartHubs
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…
Read the official notice →- Date
- 2022-05-04
- Country
- United States
- Brand
- Sight Sciences, Inc.
- Product
- TearCare version 1.0 SmartHubs
- Classification
- Class II
- Units
- US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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