Paragon Vision Sciences recalls ISee Ortho-K lenses due to lack of FDA approval. Consumers should check if their lenses are affected by lot number DI-B22208.
Manufactured lenses are not covered by existing FDA approval
Paragon Vision Sciences is recalling all ISee Ortho-K lenses with lot number DI-B222:208 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. This could lead to potential risks if used without proper regulatory oversight.
People who own or use ISee Ortho-K lenses with lot number DI-B22208 are affected. Those with the specific lot number are most at risk.
Check the lot number on your ISee Ortho-K lens packaging. The affected lot number is DI-B22208.
Look for the lot number on your ISee Ortho-K lens packaging to determine if it's affected.
No, only lenses with lot number DI-B22208 are affected.
The recall does not specify a remedy, so contact Paragon Vision Sciences for further instructions.
The recall states the lenses lack FDA approval, but the specific risk is not detailed 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-2515-2023 — Paragon Vision Sciences Paragon Vision Sciences Hello, I own a Paragon Vision Sciences that is covered by recall Z-2515-2023 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.
