HIGH

CooperVision Recalls Contact Lenses Due to Sterilization Error

CooperVision recalled 90 units of Voyant 1-Day Premium Toric contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Consumers should stop using the product immediately and follow recall instructions.

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

Product Details

The recalled product is the Voyant 1-Day Premium Toric contact lens, model number Voyant 1-Day Premium Toric. The lenses have a water content of 54% and are made from cast molded Silicone Hydrogel. The affected carton lot number is 20735504301008 and the blister lot number is 6450505898.

The Hazard

The lenses were manufactured with an invalid sterilization cycle, which poses a risk of infection or other health issues. This recall falls under Class II, indicating a high risk to health.

Reported Incidents

There are no reported injuries or incidents related to the use of the recalled contact lenses at this time.

What to Do

Stop using the recalled lenses immediately. Contact CooperVision or your healthcare provider for further instructions on how to return the product.

Contact Information

For more information, contact CooperVision at 1-800-341-2020 or visit their website. Additional details are available on the FDA enforcement report page.

Key Facts

  • Recall date: August 22, 2025
  • Quantity recalled: 90 units
  • Affected states: Florida, Kentucky, North Carolina, Wisconsin
  • Class II recall due to high risk
  • Consumers should stop using the product

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

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

Product Classification

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

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more