FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2607-2025
- Recalling firm
- CooperVision, Inc.
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2025-08-22
- Posted
- 2025-09-19
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
- 510(k) numbers
- K131378, K190965, K220070
- PMA numbers
- not on file
- Product code
- MVN
- Firm FEI
- 3005724763
- Firm city
- West Henrietta
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06