Recall Z-2606-2025
CooperVision, Inc. · initiated August 22, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Codes / lots: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Reason for recall
One lot manufactured with an invalid sterilization cycle.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2606-2025
- Initiated
- August 22, 2025
- Posted by FDA
- September 19, 2025
- Product code
- MVN – Lens, Contact, (Disposable)
- Quantity
- 4,140 units
- Distribution
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- Recalling firm
- CooperVision, Inc., West Henrietta, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2607-2025 Class II | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54%…One lot manufactured with an invalid sterilization cycle. | 08/22/2025Open, Classified |
| Z-2608-2025 Class II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day…One lot manufactured with an invalid sterilization cycle. | 08/22/2025Open, Classified |