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: AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL),
AcrySof™ IQ Vivity™ Toric Extended Vision IOLs
AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL, and
AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs

PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, Texas 76134-2099
Approval Date: February 26, 2020
Approval Letter: Approval Order

What is it?
The AcrySof™ IQ Vivity™ IOLs are artificial lenses implanted in the eye of adult patients to correct vision after having the lens removed due to a cataract. Cataracts are often the result of aging, but can have other causes. This approval expands the use to improve how well you are able to see during activities that take place:

• At an arm’s length distance such as working on a computer, applying makeup, or shaving (intermediate vision), and
• At close range, such as reading, writing, and sewing (near vision)

How does it work?
The AcrySof™ IQ Vivity™ IOLs work by bending light rays to allow those to focus on the retina (the back surface of the eye) to correct blurry distance vision that would result from removing a cataract and not replacing it with an artificial lens. The lenses also provide improved intermediate and near vision compared to a standard intraocular lens implant.

When is it used?
The AcrySof™ IQ Vivity™ Extended Vision IOL is implanted in patients 22 years of age or older during surgery to remove a cataract.

The AcrySof™ IQ Vivity™ Toric Extended Vision IOL is implanted in patients 22 years of age or older with pre-existing corneal astigmatism after a cataract surgery. The lens helps reduce the effects of presbyopia (a reduced ability of the eye to focus on objects at arm’s length or up close, caused by aging).

What will it accomplish?
The lenses have been shown to improve both intermediate and near vision in those that had lens replacement surgery with AcrySof IQ Vivity IOL, compared to the monofocal IOL.

In a clinical study, subjects diagnosed with cataract had their cataracts removed and replaced with either the AcrySof IQ Vivity IOL or a monofocal IOL. Vision testing was performed on the first eye implanted with the device using glasses that only provide correction for viewing objects far away. Six (6) months after surgery, the distance vision using glasses was good (20/25 or better) for 89% (95/107) subjects with the AcrySof IQ Vivity IOL, compared to 94% (104/113) for subjects with the control IOL. Intermediate vision was good (20/25 or better) for 37% (40/107) of subjects with the AcrySof IQ Vivity IOL, compared to 9% (10/113) for subjects with a monofocal IOL. Near vision was acceptable (20/40 or better) for 40% (43/107) subjects with the AcrySof IQ Vivity IOL, compared to 12% (13/113) for subjects with a monofocal IOL.

When should it not be used?
There are no known reasons not to use these lenses.

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

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