OVERVIEW

Sharper vision means safer vision

One of the most important benefits of improved functional vision with the TECNIS® Lens is safety.  With compromised functional vision, even patients who have no problem reading the letters on an eye chart can be at a serious disadvantage in low-light situations because they have reduced contrast sensitivity.

The TECNIS® Lens is the only wavefront-designed lens with FDA-approved claims for improved functional vision and improved night-driving simulator performance. Good functional vision is especially important when driving at night. Based on night-driving simulator results in a controlled clinical study, the TECNIS® Lens provided improved visibility that may allow for quicker reaction time, which is likely to provide a meaningful safety benefit to elderly drivers.(2) The improvement in functional vision may also improve safety in other low-visibility situations.(4)

In a simulated night-driving study, at 55 mph the TECNIS® Lens provided an additional 45 feet of identification distance, allowing for a 1/2 second of additional reaction time, when compared to a leading competitor.(2)

In addition to receiving sharp distance vision with the TECNIS® Lens, in many cases your doctor can also correct pre-existing astigmatism at the time of cataract surgery. Ask your doctor if the TECNIS® Lens can rejuvenate your vision.

Indications and Important Safety Information

TECNIS® IOLs

Indication

Tecnis® lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

General risks with cataract surgery and IOL implantation

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.

Warnings

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. Patients with recurrent severe anterior or posterior segment inflammation or uveitis.
2. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases.
3. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications.
4. A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
5. Circumstances that would result in damage to the endothelium during implantation.
6. Suspected microbial infection.
7. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.
8. Children under the age of 2 years are not suitable candidates for intraocular lenses.

Precautions

Physicians should not resterilize or autoclave the lens. Only sterile irrigating solutions such as balanced salt solution or sterile normal saline should be used to soak the lens prior to implantation. Physicians should not store the lens in direct sunlight or over 45°C.

Adverse Events

Adverse events occurred at rates between 1.6% and 3.3% during the clinical trials for Tecnis® IOLs or their “parent” IOLs. These events included macular edema, endophthalmitis, anterior lens tissue ongrowth, lens dislocation, hypopyon, corneal edema, iritis, hyphema, secondary glaucoma, and secondary surgical intervention.

References

2. Holzer MP. Data presented at the19th Congress of German Ophthalmic Surgeons (DOC), Nuremburg, Germany, 2006.
4. Data on file. Abbott Medical Optics Inc.

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