Z-2608-2025Class II

Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water...

Name: Z-2608-2025 Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water...
Creator: CooperVision, Inc.
Published: 2025-08-22
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2025-08-22 / Open, Classified / root cause: sterility

FDA source

CooperVision, Inc. began a recall of Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel... on 2025-08-22. FDA classified it as Class II and gives the reason as "One lot manufactured with an invalid sterilization cycle". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2608-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-22
Posted: 2025-09-19
Recalling firm: CooperVision, Inc.
Product: Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Product code: MVN Lens, Contact, (Disposable)
Reason for recall: One lot manufactured with an invalid sterilization cycle.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: CooperVision contacted consignees via telephone call and letter on 08/27/2025. Consignees were instructed to examine inventory and quarantine affected lot numbers, cease further distribution of product, and notify customers/patients if further distributed. Consignees were also requested to complete and return the Correction Response Form and arrange for the return of affected units.
Quantity in commerce: 90 units
Distribution: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Product codes and lots: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2608-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2606-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2607-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19
Z-2608-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19

Product code MVN

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)