Paragon Vision Sciences recalls Fargo Ortho-K lenses due to lack of FDA approval. Consumers should check if their lenses are affected by lot number B222: B22208.
Manufactured lenses are not covered by existing FDA approval
Paragon Vision Sciences is recalling all Fargo Ortho-K lenses because they were not approved by the FDA. This means the lenses may not be safe for use as intended.
The lenses were manufactured without FDA approval, which means they might not meet safety standards. Without proper approval, there could be risks like eye injury or improper vision correction.
People who own or use Fargo Ortho-K lenses are affected. Those with prescription lenses for vision correction are most at risk.
Check the lot number on your Fargo Ortho-K lens packaging. The affected lot is B22208. This recall applies to all lenses produced by Paragon Vision Sciences.
Look for the lot number on your Fargo Ortho-K lens packaging. The affected lot is B22208.
Yes, all Fargo Ortho-K lenses with lot number B22208 are affected by this recall.
The recall does not specify a remedy, so contact Paragon Vision Sciences for further instructions.
The recall states the lenses were not FDA-approved, but the specific risk level is not clearly described in the record.
We’ve drafted a message you can send Paragon Vision Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2516-2023 — Paragon Vision Sciences Paragon Vision Sciences Hello, I own a Paragon Vision Sciences that is covered by recall Z-2516-2023 from Paragon Vision 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.
