CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision
CooperVision is recalling Sofmed Breathables, (stenfilcon A) contact lens, distributed nationwide in the US. The recall was initiated on 22 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2607-2025
- FDA event ID
- 97515
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Aug 2025
- FDA classified
- 19 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Mold
- Device type
- Contact Lenses & Eye Devices
Timeline
| 22 Aug 2025 | Recall initiated by company | |
| 19 Sep 2025 | Classified by FDA | +28 days |
| 1 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot manufactured with an invalid sterilization cycle.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Questions about this recall
Is Sofmed Breathables, (stenfilcon A) contact lens recalled?
Yes. CooperVision recalled Sofmed Breathables, (stenfilcon A) contact lens on 22 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2607-2025.
Why was it recalled?
One lot manufactured with an invalid sterilization cycle.
Which lots are affected?
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Where was it sold?
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CooperVision
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Biofinity Toric Multifocal Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Biofinity XR Toric Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | (Stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 152| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS III | Akreos, SKU: AO60P0300. Akreos intraocular lenses recalled | Bausch & Lomb Surgical | Other | AZ, CA |