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.
FDA Recall Z-2607-2025 · Posted 2025-09-19
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Recalling FirmCooperVision, Inc.
Recall StatusOpen, Classified
Product CodeMVN
Date Initiated2025-08-22
Product Quantity180 units
Reason for Recall
One lot manufactured with an invalid sterilization cycle.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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