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Important Safety Information – ReZoom® Multifocal IOL

Indication:
ReZoom® multifocal intraocular lenses are indicated for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision without reading add and increased spectacle independence. These devices 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 light 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 is, 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:
In a driving simulation study, under one of nine low contrast conditions, 22% more multifocal patients than monofocal patients did not notice a hard-to-see object in the road until they were closer than 100 feet (average distance for multifocal patients was 96 feet; average distance for monofocal patients was 133 feet). The distance of 100 feet is important because at speeds of 30 mph or faster, a driver may not be able to stop safely within 100 feet. In the simulation, however, drivers could also drive around objects, and there was no difference in collisions with the objects.

There is a chance that your vision may not be good enough to read small print without glasses with the multifocal IOL. Please discuss with your doctor whether this s the right lens for you. The following may affect your choice of IOL:

  • In rare instances, this lens may make some types of retinal surgery more difficult.
  • If the pupil of your eye is very small (less than 2.5 mm), the chances are greater that your near vision with a multifocal lens will not be better than with a monofocal lens.
  • If the health of your eye makes it unlikely that your vision will be good after your cataract is removed, you may not get the full benefit of the multifocal IOL.

Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Multifocal lens was secondary surgical intervention (including lens repositioning, lens replacement due to biometry error or optical/visual symptoms, vitrectomy/vitreolysis, retinal repair), which occurred at a rate of 2.2%.

ReZoom<sup>®</sup> Multifocal IOL

Full range of vision

The ReZoom® Multifocal IOL delivers a full range of vision in varying light conditions.

Sharper Distance
The ReZoom® Multifocal IOL can provide sharp distance vision in all light conditions for all lifestyles. Three distinct distance-dominant zones provide good distance vision in bright, intermediate, and low light conditions.

Better intermediate
The ReZoom® Multifocal IOL can provide critical intermediate vision in all light conditions for all lifestyles. Using 100% of available light, the ReZoom® IOL provides proper light distribution into the intermediate range. Aspheric transitions between the Balanced View Optics™ zones further contribute to ReZoom® IOLs intermediate vision.

Versatile Near
The ReZoom® Multifocal IOL can provide crisp near vision in all light conditions for all lifestyles.

Lens Features

  • Balanced View Optics Technology for near, intermediate, and far vision in a range of light conditions
  • Aspheric transitions between zones provide intermediate vision
  • Near add of +3.5 diopters at IOL plane, +2.85 diopters at the spectacle plane
  • Hydrophobic acrylic material
  • OptiEdge® design that minimizes the potential for edge glare and facilitates 360-degree capsular contact

Full use of transmitted light

Using 100% of available light, the ReZoom® Multifocal IOL provides proper light distribution into the intermediate range.

- A recent AARP survey shows 65% of adults aged 50-64 use the computer today compared to 31% 8 years ago(1) making intermediate - computer distance - vision more important than ever before.

1. Older people going online. AARP Survey. USA Today, February 23, 2006.

Clinical Results

Only the ReZoom® Multifocal IOL delivers a full range of vision for...

  • The ReZoom® Multifocal IOL averaged 20/20 distance vision while the ReSTOR® IOL averaged 20/25, according to a recent visual acuity study1
  • Over 93% of people who received the technology in the ReZoom® Multifocal IOL experienced spectacle independence for distance vision2
  • The ReZoom® Multifocal IOL averaged J 2.15 while the ReSTOR®IOL averaged J 3.85, according to a recent visual acuity study1
  • Over 92% of people who received the technology in the ReZoom® Multifocal IOL experienced spectacle independence for intermediate vision2
  • The ReZoom® Multifocal IOL demonstrated increased reading speed compared to the ReSTOR®IOL in mesopic conditions, according to a recent study3
  • Over 81% of people who received the technology in the ReZoom® Multifocal IOL experienced spectacle independence for near vision2


  1. Akaishi, Fabri. Mix & Match Technologies. Presented at the WOC, 2006.
  2. Package Insert. ReZoom® Acrylic Multifocal Posterior Chamber Intraocular Lens. Abbott Medical Optics Inc.
  3. Huetz W, Eckhardt BH, Rohrig B. Reading ability with 3 types of multifocal lens models. J Cataract Refract Surg 2006; 32:2015-2021.

Specifications

Information for consumers

For consumer information on our ReZoom® IOL please visit

http://www.rezoomiol.com

Important Safety Information – ReZoom® Multifocal IOL

Indication:
ReZoom® multifocal intraocular lenses are indicated for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision without reading add and increased spectacle independence. These devices 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 light 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 is, 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:
In a driving simulation study, under one of nine low contrast conditions, 22% more multifocal patients than monofocal patients did not notice a hard-to-see object in the road until they were closer than 100 feet (average distance for multifocal patients was 96 feet; average distance for monofocal patients was 133 feet). The distance of 100 feet is important because at speeds of 30 mph or faster, a driver may not be able to stop safely within 100 feet. In the simulation, however, drivers could also drive around objects, and there was no difference in collisions with the objects.

There is a chance that your vision may not be good enough to read small print without glasses with the multifocal IOL. Please discuss with your doctor whether this s the right lens for you. The following may affect your choice of IOL:

  • In rare instances, this lens may make some types of retinal surgery more difficult.
  • If the pupil of your eye is very small (less than 2.5 mm), the chances are greater that your near vision with a multifocal lens will not be better than with a monofocal lens.
  • If the health of your eye makes it unlikely that your vision will be good after your cataract is removed, you may not get the full benefit of the multifocal IOL.

Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Multifocal lens was secondary surgical intervention (including lens repositioning, lens replacement due to biometry error or optical/visual symptoms, vitrectomy/vitreolysis, retinal repair), which occurred at a rate of 2.2%.