Lenses, Soft Contact, Extended Wear（LPM）

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.

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

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

Incorrect power of lenses than the expected

Incorrect power of lenses than the expected

The product may be counterfeit and could have microbial issues.

Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

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.

Portions of the lots may contain units with an incorrect lens axis condition.

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.