Reported Sep 13, 2023 · Ongoing
Fargo Ortho-K Lens
PARAGON VISION SCIENCES, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PARAGON VISION SCIENCES, Inc · 2120 W Guadalupe Rd Ste 112 · Gilbert, AZ · 85233-2810
Is this the product you have?
- Fargo Ortho-K Lens
- Lot codes and dates
- All Lots, DI - B22208
- Amount recalled
- 18,820 lenses
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Manufactured lenses are not covered by existing FDA approval
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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