Z-1352-2021Class II

EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear -

Name: Z-1352-2021 EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear -
Creator: Clerio Vision
Published: 2021-02-16
License: https://open.fda.gov/license/

Acucon / initiated 2021-02-16 / Terminated / root cause: manufacturing process

FDA source

Clerio Vision began a recall of EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or... on 2021-02-16. FDA classified it as Class II and gives the reason as "Contact lenses may be mislabeled with the incorrect lens power". 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-1352-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-16
Posted: 2021-04-05
Terminated: 2023-07-05
Recalling firm: Acucon
Product: 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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Contact lenses may be mislabeled with the incorrect lens power.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were contacted by phone on 02/16/2021 and instructed to segregate and return product with the affected lot number. An URGENT MEDICAL DEVICE RECALL were sent to impacted customers by standard USPS first class mail beginning on 03/03/2021. Customers are instructed to examine their inventory, cease all distribution and quarantine affected product, and complete and return by email the response form included with the recall notice. Customers are to return any affected inventory via US Mail, marking the package, Attention: Returns Department Recall Product. The letter instructs customers identify and notify any customers the affected product was further distributed to.
Quantity in commerce: 153 lenses
Distribution: Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Product codes and lots: Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1352-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1352-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-05

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)