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 PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60)
PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, Texas 76134-2099
Approval Date: August 26, 2019
Approval Letter: Approval Order
What is it?
The AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) are artificial lenses (Intraocular lens, IOL) implanted in the eye. Cataracts (cloudiness of the natural lens) are often the result of aging, but can have other causes. The AcrySof® IQ PanOptix® Toric IOL is an aritificial lens implant that is used to improve vision after cataract removal in people who also have blurred vision due to an irregularly shaped cornea (corneal astigmatism).
This approval expands the use to provide improved intermediate clear vision (for example, working on a computer, applying makeup or shaving) and near clear vision (for example, reading, writing, and sewing).
How does it work?
The AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) works by bending light rays to allow them to focus on the retina (the back surface of the eye) to provide for improved distance (for example, driving, playing golf), intermediate, and near vision.
When is it used?
The AcrySof® IQ PanOptix® Trifocal Intraocular Lens is implanted in patients 22 years of age or older, with less than 1 diopter of pre-existing corneal astigmatism, and have had cataract surgery.
What will it accomplish?
The AcrySof® IQ PanOptix® Trifocal Intraocular Lens reduces the effects of presbyopia (inability to focus on close images, such as reading) by providing improved intermediate and near clear vision, while maintaining comparable distance clear vision with a reduced need for eyeglasses, compared to a monofocal (one focusing distance) IOL.
In a clinical study of 243 patients implanted with either the PanOptix lens or a control lens, a total of 129 patients (256 eyes) were implanted with the PanOptix lens (127 in both eyes), and 2 patients in one eye. A total of 114 patients (225 eyes) were implanted with the control lens (111 in both eyes, 3 in one eye).
After six months of implantation, the average best corrected distance with clear vision in one eye tested was approximately 20/20 for each study group. For intermediate distance, clear vision in one eye with the PanOptix lens was approximately 20/25 compared to 20/40 for the control group. The clear vision for near distance correction with the PanOptix lens was approximately 20/25, compared to 20/63 for the control group. Overall, there were no safety concerns during the study.
When should it not be used?
There are no known reasons for not having the PanOptix lens implanted.
Additional information (including warnings, precautions, and adverse events):
Summary of Safety and Effectiveness Data (SSED) and labeling are available online at: