ClearanceBrief
Recall Z-2606-2025 ยท MVN Lens, Contact, (Disposable)

CooperVision, Inc.

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.

DateSep 19, 2025 (initiated Aug 22, 2025)
StatusOpen, Classified
ReasonOne lot manufactured with an invalid sterilization cycle.
Root causeUnder Investigation by firm
ActionCooperVision 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.
Quantity4,140 units
DistributionUS Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K131378SUS (STENFILCON A) CONTACT LENS
CooperVision, Inc., Aug 30, 2013
K190965MyDay
CooperVision, Inc., Apr 29, 2019
K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic)
CooperVision, Inc., Feb 4, 2022