Z-0808-2021Class II

Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478...

Name: Z-0808-2021 Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478...
Creator: Clerio Vision
Published: 2020-12-10
License: https://open.fda.gov/license/

Acucon / initiated 2020-12-10 / Terminated / root cause: manufacturing process

FDA source

Clerio Vision began a recall of 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... on 2020-12-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0808-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Posted: 2021-01-08
Terminated: 2023-07-05
Recalling firm: Acucon
Product: 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.
Product code: LPL Lenses, Soft Contact, Daily Wear
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter and email on 12/10/2020. The letter requested the following actions to be taken by the customer: "Distributors: Please immediately examine your inventory, cease all distribution and quarantine this product. Please complete the response form at the end of this notice and return by email to [email protected] even if you no longer have any of the product. Return any inventory via US Mail, marking the package, Attention: Returns Department Recall Product. Your account will be reimbursed for the returned goods and shipping cost. If you have further distributed this product, please identify your customers and notify them at once of this product recall. You may include this letter in your notification, or you can provide us with your customer list and we will notify them. Physicians/Opticians/Retailers: Please complete the response form at the end of this notice and return by email to [email protected] even if you no longer have any of the product. Return any inventory via US Mail, marking the package, Attention: Returns Department Recall Product. Your account will be reimbursed for the returned goods and shipping cost. If you have dispensed this product, please identify your patients/customers and notify them at once of this product recall. You may include this letter in your notification."
Quantity in commerce: 208 lenses
Distribution: US Nationwide distribution.
Product codes and lots: LOT 3100246509, EXP 2026/09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0808-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0808-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-08

Product code LPL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)