COOPERVISION INC.

One lot manufactured with an invalid sterilization cycle.

One lot manufactured with an invalid sterilization cycle.

One lot manufactured with an invalid sterilization cycle.

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

a limited number of lots were manufactured with an incorrect cylinder power.

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Incorrect power of lenses than the expected

Incorrect power of lenses than the expected

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

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.

Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.

This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Corneal epithelial edema results when there is insufficient oxygen to the eye, which may be caused by the presence of residue on the lens. Through laboratory testing and investigation, the company determined the cause of the corneal epithelial edema was a small amount of residue (silicone oil) on the lens.

Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA.

Mislabeled with incorrect sphere power.

The actual sphere power of the lens is lower than the labeled value.