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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Contact Lenses & Vision

MyDay, Sofmed, and Voyant Contact Lenses Recalled for Sterilization Issue

Agency Publication Date: September 19, 2025
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Summary

CooperVision, Inc. is recalling 4,410 units of MyDay Toric, Sofmed Breathables, and Voyant 1-Day Premium Toric (stenfilcon A) daily disposable contact lenses. These silicone hydrogel lenses were manufactured with an invalid sterilization cycle, meaning the company cannot guarantee the products are sterile. Consumers should immediately stop using these lenses and contact their eye care professional or the place of purchase for a replacement or refund.

Risk

Lenses that have not been properly sterilized may contain bacteria or other contaminants. Using non-sterile contact lenses on the eye significantly increases the risk of developing serious eye infections, irritation, or potential vision loss.

What You Should Do

  1. This recall affects MyDay Toric, Sofmed Breathables, and Voyant 1-Day Premium Toric daily disposable contact lenses sold in blister packs.
  2. Check your product packaging for Carton Lot Number 20735504301008 or individual Blister Lot Number 6450505898 to see if your lenses are affected.
  3. Stop using the recalled contact lenses immediately to prevent the risk of eye infection.
  4. Return the product to the place of purchase for a refund or replacement, throw it away, or contact your eye care provider or CooperVision for further instructions.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: MyDay Toric (stenfilcon A) Contact Lens
Variants: 54% water content, Toric, Cast moulded Silicone Hydrogel, In-monomer tinted, Daily Disposable Wear
Model / REF:
MyDay Toric
Lot Numbers:
20735504301008 (Carton)
6450505898 (Blister)

Blister packaged.

Product: Sofmed Breathables (stenfilcon A) Contact Lens
Variants: 54% water content, Toric, Cast moulded Silicone Hydrogel, In-monomer tinted, Daily Disposable Wear
Model / REF:
Sofmed Breathables
Lot Numbers:
20735504301008 (Carton)
6450505898 (Blister)

Blister packaged.

Product: Voyant 1-Day Premium Toric (stenfilcon A) Contact Lens
Variants: 54% water content, Toric, Cast moulded Silicone Hydrogel, In-monomer tinted, Daily Disposable Wear
Model / REF:
Voyant 1-Day Premium Toric
Lot Numbers:
20735504301008 (Carton)
6450505898 (Blister)

Blister packaged.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97515
Status: Active
Manufacturer: CooperVision, Inc.
Sold By: Optometrists; Ophthalmologists; Eye care clinics
Manufactured In: United States
Units Affected: 3 products (4,140 units; 180 units; 90 units)
Distributed To: Florida, Kentucky, North Carolina, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.