Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Recalled by CooperVision Inc. Due to The firm identified a labeling error affecting Made-To-Order...

Date: September 1, 2017
Company: CooperVision Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CooperVision Inc. directly.

Affected Products

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.

Quantity: 120

Why Was This Recalled?

The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.

Where Was This Sold?

USA Distribution

About CooperVision Inc.

CooperVision Inc. has 21 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report