medical MODERATE Updated 2025-10-01

CooperVision, Inc. recalls Sofmed Breathables, (stenfilcon A) contact lens. Model Numbe

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Recalled 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.

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Hazard / Issue

One lot manufactured with an invalid sterilization cycle.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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