TECNIS® IOL	Traditional IOL	TECNIS® IOL	Traditional IOL
These are simulated images to represent the difference between the TECNIS® IOL and a traditional IOL.

Traditional intraocular lenses can restore distance vision, but they aren’t designed to bring back the balance of youthful eyes. Images may not be as sharp as they could be, and you may be left with the functional vision of a healthy older person, not of a young adult.

Using innovative wavefront lens technology, the TECNIS® Lens can restore your vision to that of a younger person.(1) The TECNIS® Lens can improve functional vision so you can see well, even in low-light situations like driving at night, dining by candlelight or walking in a morning fog.(3)

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

1. Package Insert. TECNIS Foldable Posterior Chamber Intraocular Lens. Abbott Medical Optics Inc.
3. Bellucci R, Scialdone A, Buratto L, et al. Visual acuity and contrast sensitivity comparison between TECNIS and AcrySof SA60AT intraocular lenses: a multicenter randomized study. J Cataract Refract Surg. 2005;31(4):712-717.

Instructions For Use (Click below for the full version)

TECNIS® 1-Piece IOL(PDF)
TECNIS® Foldable Acrylic IOLs with OptiEdge Design(PDF)
TECNIS® CL Foldable Silicone IOL with OptiEdge Design (PDF)
UNFOLDER® Platinum 1 Series Handpiece (PDF)
UNFOLDER® Platinum 1 Series Cartridge (PDF)
One Series Ultra Cartridge (PDF)
UNFOLDER® Emerald Inserter (PDF)

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