Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 20, 2021
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
Clerio Vision recalled Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) a… — a moderate-severity action.
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) a… was recalled by Clerio Vision in January 20, 2021. Reason: One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact…. Check the official notice for the remedy. Verify recall #Z-0808-2021 with the FDA Devices before acting.
The recall
Clerio Vision issued this moderate-severity FDA Devices recall — One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact….
- Moderate
- severity level
- Class II
- classification
- January 20, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0808-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0808-2021) was formally reported on January 20, 2021, with the manufacturer initiating the action on December 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Clerio Vision is listed as the recalling firm, operating out of Sarasota, FL. Federal records list the affected scope as 208 lenses.
The documented reason for this recall is: One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
208 lenses
Related Recalls
6
6 from same agency
Product description
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Reason for recall
One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0808-2021 |
| Date reported | January 20, 2021 |
| Date initiated | December 10, 2020 |
| Recalling firm | Clerio Vision |
| Firm location | Sarasota, FL |
| Affected scope | 208 lenses |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0808-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.. Recalled by Clerio Vision. Units affected: 208 lenses.
Why was this product recalled? ▼
One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0808-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0808-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 20, 2021.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.