Indications and Important Safety Information IFU
Glossary

FREQUENTLY ASKED QUESTIONS ABOUT THE REZOOM® MULTIFOCAL LENS AND THE PROCEDURE

Q: Will I still need to wear glasses if my surgeon recommends a ReZoom® Multifocal Lens?

A: The results will vary depending upon your vision, lifestyle and the anatomy of your eyes. Most people find that they need glasses to read small type or drive at night. Most people, however, can go to the store or conduct many of their day’s activities without depending on glasses. In a clinical study, 92% of those who received the technology in ReZoom® Multifocal Lenses “never” or only “occasionally” needed to wear glasses.(1)

Q: How is the ReZoom® Multifocal Lens different from traditional monofocal intraocular lenses?

A: The ReZoom® Multifocal Lens is a multifocal intraocular lens. Unlike traditional monofocal (single-vision) lens implants, the ReZoom® Multifocal Lens provides quality vision at all distances – near (reading), intermediate (computer use or cooking), and far (driving). Traditional monofocal lenses usually provide good vision only at a distance with limited ability to see objects that are near without glasses.

Q: How does the ReZoom® Multifocal Lens replace the cataract?

A: The natural lens inside the eye is gently removed through a tiny incision in the periphery of your eye’s cornea. The cataract-impaired lens is then removed through this incision and the lens implant is inserted in its place to permanently replace it. The procedure usually takes about 15 to 45 minutes and vision is usually improved immediately.

Q: What if my medical history or current medication prevents me from considering an injection of local anesthesia?

A: Today, anesthesia may also be administered topically. This means no injection is required, and the medication numbs the eye without entering the bloodstream. Your physician can tell you if this is an appropriate option for you.

Q: How long after surgery until I see my best?

A: Like most procedures, this depends upon the overall health of your eye. For most people, vision is noticeably better immediately and continues to improve during the first few weeks after the procedure.

 

Q: Does the ReZoom® Multifocal Lens require an adjustment period?

A: Yes. For most people there is a period of weeks when your brain is learning to "see" up close and at a distance with the new lens. This adjustment period is usually complete within 6 to 12 weeks. Also, like all multifocal lenses, some people report halos or glare around lights. Again, for most people this diminishes over time. For some, it becomes less troublesome but never completely goes away. Most people report that the ability to see near, intermediate and far outweighs any visual side effects associated with the lens.

Q: Are there any risks of having the ReZoom® Multifocal Lens procedure?

A: As with any surgical procedure there are risks. The biggest risk with any cataract procedure is infection. Fewer than 1% of patients having a lens implant procedure ever get an infection and most are treated successfully with medications. Infections, however, can cause a severe or total loss of vision.

Indications and Important Safety Information

Indication Statement

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 is 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%.

 

REFERENCES

1. Package Insert. ReZoom® Acrylic Multifocal Posterior Chamber Intraocular Lens. Abbott Medical Optics Inc.

 

 

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