Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mould
FDA device recall Z-2607-2025 · posted 2025-09-19 · Open, Classified
Recall details
- Recalling firm
- CooperVision, Inc.
- Reason for recall
- One lot manufactured with an invalid sterilization cycle.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MVN
- Quantity affected
- 180 units
- Distribution
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- Date initiated
- 2025-08-22
- Date posted
- 2025-09-19
- Location
- West Henrietta, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070) | CooperVision, Inc. | 2022-02-04 |
| MyDay (K190965) | CooperVision, Inc. | 2019-04-29 |
| SUS (STENFILCON A) CONTACT LENS (K131378) | CooperVision, Inc. | 2013-08-30 |