Class II

Medical Device Recall: 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 W

CooperVision, Inc. · August 22, 2025

Reason for Recall

One lot manufactured with an invalid sterilization cycle.

Product Description

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.

Distribution

US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.

States Affected

NATIONWIDE

Quantity Affected

180 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2607-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

CooperVision, Inc. Medical Device Recall: 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 W | SafeCheck