CLASS II Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
extreme H2O monthly, MED, DIA 14.0 PWR recalled by Clerio Vision
Clerio Vision is recalling extreme H2O monthly, MED, DIA 14.0 PWR -2.25, distributed nationwide in the US. The recall was initiated on 10 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0808-2021
- FDA event ID
- 86952
- Recalling firm
- Clerio Vision, Sarasota, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2020
- FDA classified
- 8 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2020 | Recall initiated by company | |
| 8 Jan 2021 | Classified by FDA | +29 days |
| 20 Jan 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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 lots are affected?
LOT 3100246509, EXP 2026/09
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Clerio Vision
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extreme H2O 59% (hioxifilcon A) spherical soft contact lens recalled | Clerio Vision | Labeling Errors | Nationwide |
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