FDA recall Z-2607-2025

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.

Reason for recall

One lot manufactured with an invalid sterilization cycle.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-08-22

Report date

2025-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2607-2025