HIGH

CooperVision Recalls MyDay Toric Contact Lenses Over Sterilization Issue

CooperVision recalled 4,140 units of MyDay Toric contact lenses on August 22, 2025, due to an invalid sterilization cycle. The recall affects lenses distributed nationwide, particularly in Florida, Kentucky, North Carolina, and Wisconsin. Users must stop using these lenses immediately to avoid potential health risks.

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 the MyDay Toric contact lens, made from stenfilcon A silicone hydrogel with 54% water content. The affected carton lot number is 20735504301008, and the blister lot number is 6450505898. These lenses were distributed across multiple states in the U.S.

The Hazard

The recall stems from a manufacturing error where one lot of lenses was produced with an invalid sterilization cycle. This could potentially expose users to harmful bacteria or other pathogens.

Reported Incidents

No injuries have been reported at this time. However, the high hazard level indicates a significant risk of eye infections or other complications.

What to Do

Patients and healthcare providers should stop using the MyDay Toric contact lenses immediately. Follow the manufacturer's recall instructions and contact CooperVision, Inc. or your healthcare provider for further guidance.

Contact Information

For more information, reach CooperVision at the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2606-2025.

Key Facts

  • Recall date: August 22, 2025
  • Report date: October 1, 2025
  • Quantity recalled: 4,140 units
  • Affected states: Florida, Kentucky, North Carolina, Wisconsin

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Safety Assessment

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

Product Details

Model Numbers
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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