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Lower risk Medical device recall · FDA · Published February 16, 2021

Clerio Vision Extreme H2O 5: Contact Lenses May Be Mislabeled

Clerio Vision recalls Extreme H2O 59% contact lenses that may be mislabeled with incorrect lens power. Affected lenses have specific lot numbers and UPC codes. Consumers should check their lenses for proper labeling.

🇺🇸 FDA recall #Z-1352-2021Medical deviceClerio Vision ›
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Recalling firmClerio Vision7575 Commerce Ct · Sarasota, FL 34243-3218
✎ GovInfoNow plain-language explainer

What happened, in plain English

Clerio Vision is recalling Extreme H2O 59% spherical soft contact lenses for daily wear because they may be mislabeled with the wrong lens power. This could lead to improper vision correction if the lenses are used without the correct prescription. Read more at govinfonow.com/recall/63266-clerio-vision-extreme-h2o-5-contact-lenses-may-be-mislabeled.

Source Summary by GovInfoNow · govinfonow.com/recall/63266-clerio-vision-extreme-h2o-5-contact-lenses-may-be-mislabeled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1352-2021

Cite this page

“Clerio Vision Extreme H2O 5: Contact Lenses May Be Mislabeled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63266-clerio-vision-extreme-h2o-5-contact-lenses-may-be-mislabeled. Based on FDA recall #Z-1352-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2021%22&limit=1).

Why it’s dangerous

The lenses may have incorrect lens power labels, which could result in improper vision correction. This might cause blurry vision or discomfort if the lenses are not the right prescription for the user's eyes.

Who’s affected

People who own or use Extreme H2O 59% contact lenses with lot number 0114511565 or UPC codes 675506700657 (6-pack) or 675506668650 (individual) are affected. Those with astigmatism under 0.75 Diopters may be at higher risk if the lenses are mislabeled.

How to tell if you have this one

Check for lot number 0114511565 or UPC codes 675506700657 (6-pack) or 675506668650 (individual) on the packaging. The lenses are intended for daily wear and correction of vision in people with non-diseased eyes.

  • Brand
    Clerio Vision
  • Product
    EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lens Label

    Look for the lot number 0114511565 or UPC codes 675506700657 (6-pack) or 675506668650 (individual) on the lens packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Illinois, Missouri.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Feb 16, 202112. FDA classified it Class II: Apr 5, 202123. Published in FDA’s Enforcement Report: Apr 14, 202134. FDA terminated the recall: Jul 5, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1352-2021 (February 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1352-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA