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Recall Observatory FDA recall evidence

Device 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.

Z-2607-2025

August 22, 2025

Class II

Product summary

Firm
CooperVision, Inc.
Event
Event 97515
Status
Ongoing
Classification
Class II
Quantity
180 units
Official record key
device-enforcement:Z-2607-2025

Official wording

Reason: One lot manufactured with an invalid sterilization cycle.

Code information: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot manufactured with an invalid sterilization cycle.