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Lower risk Medical device recall · FDA · Published December 10, 2020

Clerio Vision Contact Lenses Recall: Wrong Power in One Lot

Clerio Vision recalls specific contact lens lots (UPC 675506803334 and 675506804478) due to incorrect lens power. These lenses may cause vision issues if used.

🇺🇸 FDA recall #Z-0808-2021Medical deviceClerio Vision ›
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Recalling firmClerio Vision7575 Commerce Ct · Sarasota, FL 34243-3218
✎ GovInfoNow plain-language explainer

Clerio Vision is recalling two specific lots of contact lenses that contain the wrong power (PWR -3.75 instead of -2.25). Using these lenses could lead to vision problems because they are not designed for the intended correction. Read more at govinfonow.com/recall/63695-clerio-vision-contact-lenses-recall-wrong-power-in-one-lot.

Source Summary by GovInfoNow · govinfonow.com/recall/63695-clerio-vision-contact-lenses-recall-wrong-power-in-one-lot · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0808-2021

Cite this page

“Clerio Vision Contact Lenses Recall: Wrong Power in One Lot.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63695-clerio-vision-contact-lenses-recall-wrong-power-in-one-lot. Based on FDA recall #Z-0808-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0808-2021%22&limit=1).

The FDA announced on Dec. 10, 2020, that Clerio Vision recalled specific lots of extreme H2O monthly contact lenses due to incorrect power labeling. Owners should stop using the product and contact the company for a refund.

How to tell if you have it

  • Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25
  • UPC 675506803334 (6 count)
  • UPC 675506804478 (12 count)
  • Lot 3100246509, EXP 2026/09

The hazard

One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained lenses with the incorrect power of PWR -3.75. The FDA said this mislabeling could result in blurred vision or eye strain for users.

Context

GovInfoNow's records show Clerio Vision has one other recall on record since Feb. 16, 2021. On Feb. 16, 2021, the brand recalled Extreme H2O 5 contact lenses because they may be mislabeled with incorrect lens power. Other recent recalls of similar products include CooperVision Pearle Vision 1 Day Contact Lenses (Aug. 12, 2026) due to incorrect power risk.

How to tell if you have this one

Check the UPC codes on the packaging: 675506803334 (6 lenses) or 675506804478 (12 lenses). The lot number 3100246509 and expiration date 2026/09 are also associated with this recall.

  • Brand
    Clerio Vision
  • Product
    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product UPC

    Look for the UPC codes 675506803334 (6 count) or 675506804478 (12 count) on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Dec 10, 202012. FDA classified it Class II: Jan 8, 202123. Published in FDA’s Enforcement Report: Jan 20, 202134. FDA terminated the recall: Jul 5, 2023420202023
  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-0808-2021 (December 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0808-2021 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