Recall Z-2607-2025 ยท MVN Lens, Contact, (Disposable)
CooperVision, Inc.
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
| Date | Sep 19, 2025 (initiated Aug 22, 2025) |
| Status | Open, Classified |
| Reason | One lot manufactured with an invalid sterilization cycle. |
| 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 | 180 units |
| Distribution | US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin. |
| FDA record | Open on fda.gov |