FDA Announces Recall of Certain CooperVision Sofmed Breathables Advanced Toric Contact Lenses

The U.S. Food and Drug Administration (FDA) has announced a Class II recall involving certain CooperVision Sofmed Breathables Advanced Toric contact lenses due to incorrect information printed on the product packaging.
 

The recall affects approximately 230,856 contact lenses distributed in Florida, Kentucky, and Michigan.
 

At Eyes & Optics, we want contact lens wearers throughout Farmington Hills and Metro Detroit to understand what this recall means, which lenses are affected, and what steps to take if they have purchased this product.
 

Why Were These Contact Lenses Recalled?

CooperVision initiated the recall on September 22, 2026, and the FDA classified it as a Class II recall on October 22, 2026.
 

The affected contact lens boxes incorrectly state that the lenses are indicated for extended wear.
 

However, Sofmed Breathables Advanced Toric contact lenses are intended for daily wear and are not FDA-approved for extended wear, which involves sleeping in contact lenses.
 

The recall was issued because this incorrect labeling could lead patients to believe that sleeping in these lenses is safe.
 

Importantly, the FDA recall notice identifies a labeling problem rather than a defect in the contact lens material itself.
 

Why Is Sleeping in Contact Lenses a Concern?

Sleeping in contact lenses that are not approved for overnight wear increases the risk of complications, including corneal infections.
 

Contact lenses can reduce the amount of oxygen reaching the cornea, particularly when the eyes are closed. Overnight wear can also increase the risk of microbial keratitis, a potentially serious infection that can threaten vision.
 

Even contact lenses approved for extended wear carry additional risks compared with removing lenses before sleeping.
 

Unless your eye doctor has specifically prescribed an approved overnight-wear lens and explained the associated risks, contact lenses should be removed before going to sleep.
 

Which Contact Lenses Are Affected?

The recall specifically involves certain lots of CooperVision Sofmed Breathables Advanced Toric (fanfilcon A) contact lenses.
 

These are silicone hydrogel toric lenses designed to correct astigmatism.
 

Not every CooperVision contact lens is included in this recall, and not every box of Sofmed Breathables Advanced Toric lenses is necessarily affected.
 

Patients can identify affected products by checking the product name, packaging, and lot number against the FDA's official recall information.
 

The FDA reports that affected products were distributed in Michigan, Florida, and Kentucky.
 

What Should You Do if You Have These Contact Lenses?

If you use Sofmed Breathables Advanced Toric contact lenses, we recommend taking the following steps:

1. Check the product name on your contact lens box.

2. Look for labeling that states "Indicated for Extended Wear."

3. Check the lot number against the affected lot numbers listed in the FDA recall notice.

4. If your lenses are affected, discontinue use and contact your eye care provider or the location where you purchased them.

5. Follow the recall instructions for returning affected lenses and obtaining replacements.

Do not sleep in these contact lenses, even if the packaging indicates that extended wear is permitted.
 

If you experience eye pain, redness, light sensitivity, blurred vision, or unusual discomfort while wearing contact lenses, remove them immediately and seek urgent eye care.
 

What Does a Class II Recall Mean?

The FDA uses several classifications to describe the potential health risks associated with recalled medical products.
 

A Class II recall generally means that use of the affected product could cause temporary or medically reversible health problems, while the likelihood of serious adverse consequences is considered remote.
 

In this case, the primary concern is that incorrect packaging instructions could encourage patients to wear contact lenses overnight when they are not approved for that purpose.
 

The FDA recall report identifies incorrect labeling as the reason for the recall.
 

Looking for an Alternative to Sofmed Contact Lenses?

Sofmed is a contact lens brand sold exclusively through America's Best and is not available at Eyes & Optics.
 

If you currently wear Sofmed Breathables Advanced Toric lenses, this may be a good opportunity to schedule a contact lens examination and explore other available options.
 

At Eyes & Optics, our doctors can evaluate your current prescription, assess your eye health and contact lens fit, and help you transition to a different contact lens brand that meets your visual needs.
 

We offer a variety of contact lens options for patients with astigmatism, including daily disposable and reusable lenses.
 

Whether you're concerned about the recent recall or simply interested in trying a different contact lens, we're happy to help you find an appropriate alternative.
 

Contact Lens Safety at Eyes & Optics

Contact lenses can provide comfortable, clear vision when properly fitted and worn according to their prescribed schedule.
 

Our doctors emphasize proper lens care, safe wearing habits, and regular follow-up examinations to help reduce the risk of complications.
 

If you have questions about the CooperVision recall or would like to explore a different contact lens option, call Eyes & Optics at 248-788-1610 to schedule an appointment.
 

At Eyes & Optics, we're proud to provide personalized eye care for individuals and families in Farmington, Farmington Hills, Novi, Commerce Township, West Bloomfield, Walled Lake, Livonia, Northville, Orchard Lake, Plymouth, Wixom and surrounding Metro Detroit communities.
 

Sources

1. U.S. Food and Drug Administration. Class II Device Recall: Sofmed Breathables Advanced Toric. Recall initiated September 22, 2026; classified October 22, 2026.

2. Delaney-Gesing A. FDA Updates Recall for CooperVision's Sofmed Breathables Advanced Toric Contact Lenses. Glance by Eyes On Eyecare. October 29, 2026.

3. Centers for Disease Control and Prevention. Healthy Contact Lens Wear and Care.

4. America's Best Contacts & Eyeglasses. Sofmed Contact Lenses.