CATARACTS

IMPORTANT PRODUCT INFORMATION – CLAREON® FAMILY OF IOLS

CAUTION: Restricted by law to sale by or on the order of a physician.

DESCRIPTION: The Clareon® Family of Lenses are artificial lenses implanted in the eye of adult patients following cataract surgery. The Clareon® Aspheric Hydrophobic Acrylic IOLs are designed to allow for clear distance vision. However, you will likely still need glasses for reading and for distance vision particularly if you already have astigmatism. The Clareon® PanOptix® Trifocal Hydrophobic IOL is a type of multifocal lens (sometimes called “presbyopia-correcting IOL”) designed to allow for clear distance, intermediate, and near vision with the potential to be more independent of the need to use glasses for daily tasks. The Clareon® Vivity® Extended Vision Hydrophobic Posterior Chamber IOL provides clear distance vision, and better intermediate and some near vision compared to a monofocal IOL. The Clareon® Aspheric Toric, Clareon® PanOptix® Toric, and Clareon® Vivity® Toric IOLs are also designed to correct pre-existing corneal astigmatism, which is the inability of the eye to focus clearly at any distance because of difference curvatures on the cornea, and provide distance vision.

WARNINGS / PRECAUTIONS: You may experience and need to contact your eye doctor immediately if you have any of the following symptoms after cataract surgery: itching, redness, watering of your eye, sensitivity to light. The safety and effectiveness of these IOLs have not been established in patients with eye conditions, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). As with any surgical procedure, there are risks involved. These risks may include but are not limited to infection, damage to the lining of the cornea, the retinal layer which lines the inside back wall of your eye may become separated from the tissue next to it (retinal detachment), inflammation or swelling inside or outside the eye, damage to the iris (the colored diaphragm around the pupil), or an increase in eye pressure that cannot be controlled by medicine and secondary surgical procedure. There is a possibility that the IOL may be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision, or it may cause visual symptoms. The Clareon® Aspheric Toric, Clareon® PanOptix® Toric, and Clareon® Vivity® Toric IOLs correct astigmatism only when placed in the correct position in the eye. There is a possibility that these Toric IOLs could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your astigmatism has not been fully corrected, or it may cause visual symptoms. With the Clareon® PanOptix® and Clareon® Vivity® IOLs, there may be a loss of sharpness of your vision that may become worse in dim light or in foggy conditions. There is also a possibility that you may have some visual effects such as rings or circles (halos) around lights at night. You may also have trouble seeing street signs due to bright lights or glare from oncoming headlights.

ATTENTION: As with any surgical procedure, there are risks involved. Prior to surgery, ask your eye doctor to provide you with the Patient Information Brochure for the lens to be implanted. This Brochure which will inform you of the risks and benefits associated with the IOL. Discuss any questions about possible risks and benefits associated with your eye doctor.

REFERENCES:

1. Clareon® PanOptix® Trifocal Hydrophobic Acrylic IOL Model CNWTT0 2021 Directions for Use.
2. Zhu D, Ren S, Mills K, Hull J, Dhariwal M. Rate of Complete Spectacle Independence with a Trifocal Intraocular Lens: A Systematic Literature Review and Meta-Analysis. Ophthalmol Ther. 2023;12(2):1157-1171.
3. Clareon® Vivity® Extended Vision Hydrophobic IOL (CNWET0) Directions for Use – USA.
4. Clareon® Toric Directions for Use.
5. Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021;15:1647-1657. Published 2021 Apr 20.
6. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL. J Cataract Refract Surg. 2019;45:1490-1497.
*. Davis G. The Evolution of Cataract Surgery. Mo Med. 2016;113(1):58-62.