HIGH

CooperVision Recalls Sofmed Breathables Contact Lenses Over Sterilization Issue

CooperVision recalled 180 units of Sofmed Breathables contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Patients and healthcare providers must stop using the affected lenses immediately.

Quick Facts at a Glance

Recall Date
August 22, 2025
Hazard Level
HIGH
Brand
CooperVision
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

One lot manufactured with an invalid sterilization cycle.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CooperVision, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recalled product is Sofmed Breathables contact lenses, model number Softmed Breathables. They contain 54% water and are made from toric, cast-moulded silicone hydrogel. The affected lot includes carton lot number 20735504301008 and blister lot number 6450505898.

The Hazard

The recall involves lenses from a lot that failed to undergo proper sterilization, posing a risk of infection or other serious eye conditions. This issue falls under Class II classification, indicating a potential for temporary or medically reversible health consequences.

Reported Incidents

As of the latest report, there are no injuries or infections linked to this recall. Consumers are urged to return the product as a precaution.

What to Do

Patients and healthcare providers should stop using the affected contact lenses immediately. For instructions, contact CooperVision or your healthcare provider. Follow the recall instructions provided via email, fax, letter, or phone.

Contact Information

For further information, contact CooperVision at the customer service number provided in the recall notification. More details can be found at the FDA's website.

Key Facts

  • Recall date: August 22, 2025
  • Distribution: Nationwide in Florida, Kentucky, North Carolina, and Wisconsin
  • Quantity recalled: 180 units
  • Status: Active
  • Class II recall

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Softmed Breathables
Carton Lot Number: 20735504301008
Blister Lot Number: 6450505898
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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