Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 14, 2021
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: 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.
Contact lenses may be mislabeled with the incorrect lens power.
Clerio Vision recalled EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usag… - a moderate-severity action.
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usag… was recalled by Clerio Vision in April 14, 2021. Reason: Contact lenses may be mislabeled with the incorrect lens power.. Check the official notice for the remedy. Verify recall #Z-1352-2021 with the FDA Devices before acting.
The recall
Clerio Vision issued this moderate-severity FDA Devices recall-Contact lenses may be mislabeled with the incorrect lens power..
- Moderate
- severity level
- Class II
- classification
- April 14, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1352-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1352-2021) was formally reported on April 14, 2021, with the manufacturer initiating the action on February 16, 2021. 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 153 lenses.
The documented reason for this recall is: Contact lenses may be mislabeled with the incorrect lens power. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 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
153 lenses
Related Recalls
6
3 from same agency
Product description
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: 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
Contact lenses may be mislabeled with the incorrect lens power.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1352-2021 |
| Date reported | April 14, 2021 |
| Date initiated | February 16, 2021 |
| Recalling firm | Clerio Vision |
| Firm location | Sarasota, FL |
| Affected scope | 153 lenses |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland. |
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-1352-2021) 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? ▼
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: 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: 153 lenses.
Why was this product recalled? ▼
Contact lenses may be mislabeled with the incorrect lens power.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1352-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1352-2021) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 14, 2021. 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 July 2026.