This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:

• Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model SY60WF)
• Clareon Toric Aspheric Hydrophobic Acrylic IOL (Models CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and CNW0T9)
• Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Pre-loaded Delivery System (Model CNA0T0)
• Clareon Toric Aspheric Hydrophobic Acrylic IOL with the AutonoMe Pre-loaded Delivery System (Models CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8 and CNA0T9)

PMA Applicant: Alcon Research, Ltd.
Address:  6201 South Freeway, Fort Worth, TX 76134
Approval Date:   January 7, 2020
Approval Letter:  Approval Order

What is it?

The Clareon Aspheric Hydrophobic Acrylic IOL and Clareon Toric Aspheric Hydrophobic Acrylic IOL are plastic lenses used to replace a natural eye lens that has become cloudy (cataract) and improve distance vision. The Clareon Toric Aspheric Hydrophobic Acrylic IOL also improves vision after cataract removal in people who have blurriness due to the shape of their cornea (corneal astigmatism).

How does it work?

The IOL bends light rays, focusing the light straight onto the retina to make distance vision better, which is needed for driving and other things that need clear sight of faraway objects.

When is it used?

The Clareon Aspheric Hydrophobic Acrylic IOL is used in patients 22 years of age or older who have cataract removal surgery. The Clareon Toric Aspheric Hydrophobic Acrylic IOL is used in patients 22 years of age or older who already have corneal astigmatism and have also had cataract surgery.

What will it accomplish?

The IOL may improve distance vision after cataract removal. In a clinical study of 350 patients with the Clareon Aspheric Hydrophobic Acrylic IOL in one eye, 87% of patients had 20/20 vision in the implanted eye, and 99.4% of patients had 20/32 vision in the implanted eye after 12 months.

When should it not be used?

There are no known reasons for not using this device.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling
• Physician Labeling
• PMA Database Entry