Indications and Important Safety Information
IFU (Full Version)

What are my lens choices?

The artificial replacement lens used to replace your cataracts is called an intraocular lens or IOL for short. These IOLs are very small and are highly advanced medical devices that are designed to mimic your natural crystalline lens.

Different types of implantable lenses are designed to meet individual eye health and lifestyle needs, so be sure to talk to your doctor about which lens is right for you.

Monofocal lens: This traditional lens will give you good vision for seeing objects in the distance, such as when you’re driving. For near vision, such as reading or surfing the Internet, you will typically need to wear glasses. There are many types of monofocal lenses that you can choose. You can ask your doctor which one is best for you.

Multifocal lens: These types of lenses are designed to be able to provide patients the ability to see objects clearly at different distances without glasses—near, far, and everywhere in between. The lens material distributes light to different distances, which the eye can focus on for sharper vision. For people who are active and find wearing glasses inconvenient, the multifocal lens can be the optimal choice.

Lenses with the most advanced technological innovations are designed to give nearly everyone independence from glasses. For example, the TECNIS® Multifocal lens is intended to give people high-quality vision in a range of light conditions, including low light situations, such as driving at night and reading a menu in a dimly lit restaurant.

Some patients may notice rings or halos around light when driving at night right after surgery. But over time, the visual impression of these rings typically lessens or goes away, as your eye and brain adapt to the lens. You can find more information about this lens at www.TECNISMultifocal.com.

*Artistic rendering of vision that may be possible with the TECNIS® Multifocal IOL.

Accommodating lens: This type of lens is designed to shift or move with the muscles in the eye to help patients focus at different distances. These lenses attempt to change focal points by moving back and forth in the eye—closer to the front of the eye for near vision and then toward the back of the eye for distance vision. With an accommodating lens, some people don’t require glasses for up-close vision.

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Reference: 1. Terwee T, Weeber H, van der Mooren M, Piers P. Visualization of the retinal image in an eye model with spherical and aspheric, diffractive, and refractive multifocal intraocular lenses. J Refract Surg. 2008;24:223-232.

Caution: Federal law restricts this device to sale by or on the order of a physician. Indication: TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. Risks: As with many things, there may be a trade-off. If you decide to have a multifocal lens, your use of glasses may decrease, but at the cost of losing some of the sharpness of your vision. Even with glasses, this loss of sharpness may become worse under poor visibility conditions such as dim lighting or fog. There may also be some visual side effects, such as halos and glare from lights at night, that are more common than with a monofocal IOL. Halos are rings of light that you may notice when looking directly at a source of light, such as oncoming car headlights. Glare is a scattered light effect that can appear around a source of light. General risks with cataract surgery and IOL implantation: Whatever your lens choice, there are risks and possible complications of cataract surgery and lens implantation. Complications could be minor or temporary, or could permanently affect your vision. Complications are rare and may include the worsening of your vision, bleeding, or infection. Contact your eye doctor right away if you have any of the following symptoms after surgery: itching, pain, flashing lights, “floaters,” a “curtain” in your vision, redness, severe headache, nausea/vomiting, sensitivity to light, or watery eye. PLEASE NOTE: Warnings and precautions accompany all IOLs because they are prescription-only medical devices. The following warnings and precautions apply to all multifocal IOLs. Warnings: A very small number of patients (less than 1% in U.S. clinical studies) may be dissatisfied and request removal of their multifocal IOL. Under poor visibility conditions, your vision may be reduced more than it would be with a monofocal IOL. Under these conditions, you may have more difficulty recognizing some traffic signs and hard-to-see objects in the road. Therefore, you may need to take extra care when driving, especially in poor light conditions. In rare instances, multifocal IOLs may make some types of retinal surgery more difficult. Precautions: If your eye is not healthy (including glaucoma), your vision may not be good even after your cataract is removed. In this case, you may not get the full benefit of the multifocal IOL. Before surgery, your eye doctor will check to see if you have any eye diseases. Be sure to tell your eye doctor if you have any health conditions that may affect your surgery or vision, and provide an updated list of medications to the doctor. There is a chance that your vision with a multifocal IOL may not be good enough to perform very near or detailed “up-close” work without glasses. The TECNIS® Multifocal IOL is designed for near vision at approximately 13 inches. Take all prescribed medicines and apply eye drops as instructed. You should avoid any activity that could harm your eye while you are recovering from surgery. Before and after the surgery, your eye doctor will tell you about activity restrictions. If you wear contact lenses, your eye doctor may ask you to discontinue wearing your lenses prior to being evaluated for the multifocal IOL. There were no patients 21 years old or younger included in the clinical study. As a result, there are insufficient data to support the safety and effectiveness of this IOL in this age group. Adverse events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was surgical reintervention, which occurred at a rate of 3.7% (lens-related: 0.6%; non–lens-related: 3.2%). Surgical reintervention included lens exchange, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and lens removal due to patient dissatisfaction. The second most frequent adverse event was macular edema, which occurred at a rate of 2.6%. Other reported reactions were hypopyon and endophthalmitis, each occurring at a rate of 0.3%.