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Important Safety Information – Tecnis® IOLs (For Physicians)

Caution:
Federal law restricts this device to sale by or on the order of a physician.

Indications:
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.

Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens.

Precautions: Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store 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.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

TECNIS<sup>®</sup> 3-Piece IOL

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.

Give your patients rejuvenated vision by reducing spherical aberration close to 0.0*

Peak visual performance occurs at age 19, when the average spherical aberration is close to 0.0 microns.1 As spherical aberration increases with age, contrast sensitivity decreases.2 Cataract surgery is a once-in-a-lifetime opportunity to reverse this effect and TECNIS® is the only aspheric IOL designed to reduce spherical aberration to 0.0, and bring back youthful vision similar to that of a 19-year old.1,3,4

To learn more about the innovative TECNIS® IOL, available in both hydrophobic acrylic and silicone materials, please explore the topics on this site.

*Based on average cataract patient

Lens Features

The TECNIS® Monofocal IOL is the FIRST and ONLY wavefront designed IOL with claims approved by the FDA for:

  • Reduced spherical aberration3
  • Improved functional vision3
  • Improved night driving simulator performance3

The TECNIS® IOL reduces spherical aberration to essentially zero3

A clinical study showed that the average ocular spherical aberration of TECNIS® IOL eyes was not significantly different from zero.3

Total Ocular Spherical Aberration of TECNIS® IOL Eyes is Not Significantly Different From Zero3

Mean Spherical Aberration Measurements, 90±15 Days Postoperatively, Study 001: Z9000: N=25; Lens with Spherical Optic: N=243

Improved Functional Vision

TECNIS® Monofocal IOLs are likely to provide a meaningful safety benefit to elderly drivers3

In a simulated night-driving study, at 55 mph the TECNIS® Lens provided an additional 45 feet of identification distance, allows for a second of additional reaction time, when compared to a leading competitor.3
  • In one study, the TECNIS® Monofocal lens improved the identification distance for a pedestrian hazard by 45 feet compared to a traditional spherical lens implant3
  • At 55 mph, the 45-foot increase in visibility with the TECNIS® Monofocal lens allows for an additional half-second (0.50 second) to perceive and react to a driving hazard compared to a traditional spherical lens implant3,10
  • In comparison, the addition of the center high-mounted brake lights only improved driver reaction time by 0.35 seconds10

Why target zero SA?

Best possible vision targets essentially zero spherical aberration

To rejuvenate vision to youthful levels, it is necessary to reduce or eliminate spherical aberration. Other intraocular lenses provide excellent visual acuity but do not address the increase in spherical aberration that occurs with age, leaving vision like that of an eye of a healthy older person. Only TECNIS® IOL is designed to reduce spherical aberration to essentially zero, restoring vision like that of a 19-year old.1,4

On the average, the young eye has essentially zero spherical aberration1,11-15

Eye diagram is not to scale
  • Peak visual performance occurs at age 19; this is when contrast sensitivity and quality of vision peak1,11-15
  • The negative spherical aberration of the young crystalline lens balances the positive spherical aberration of the cornea6
  • Light on the retina is sharply focused, producing a high-quality, sharp image

With age, spherical aberration increases, reducing functional vision6,16

Eye diagram is not to scale
  • The aging crystalline lens loses its ability to compensate for positive corneal spherical aberration
  • Spherical aberration causes diffusion of light resulting in blurred vision, reduced contrast sensitivity, and decreased functional vision
  • Patients with decreased functional vision may lack confidence in low-light situations or have difficulty with night driving or glare17

The TECNIS® IOL reduces spherical aberration for improved functional vision

  • Clinical data submitted to the FDA showed that the TECNIS® Monofocal IOL provides a significant improvement in functional vision3

Competitive Advantage

The design of other IOLs (both spherical and aspheric) leave positive spherical aberration. The result is a diffusion of the light reaching the retina and a reduction in contrast sensitivity.

Residual Spherical Aberration (SA) of Monofocal Lenses (4 mm pupil)16
*Images simulated using ZernikeTool, created by George Dai, PhD.
†The point spread function (PSF) is the shape of a single, concentrated ray of light as it is projected through a lens. PSF is used to describe the distortion caused by aberrations present in an optical system.
††SA correction of lens at corneal plane.

The TECNIS® IOL shows significant improvement in Modulation Transfer Function (MTF) compared to other aspheric lenses

In one study, the TECNIS® IOL shows over twice the improvement in MTF at 100 c/mm versus AcrySof®** IQ SN60WF and over three times the improvement in MTF at 100 c/mm versus LI61AO and Canon Staar** KS-3Ai.18 In fact, LI61AO performs similarly to a spherical lens.

MTF Comparison of Lens Models (5 mm pupil)18

Modulation transfer function (MTF) measures the ability of an optical system to transfer contrast. The higher the MTF on the graph above, the higher percentage of contrast the lens is transferring for a given image.
(*Average Cornea Eye model)

**AcrySof is a trademark of Novartis International AG; Canon Staar is a trademark of Staar Surgical Company

References

  1. Artal P, Alcón E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at: XXIV Congress of the European Society of Cataract and Refractive Surgeons; September 9-13, 2006; London, England.
  2. Artal P, Berrio E, Guirao A, Piers P. Contribution of the cornea and internal surfaces to the change of ocular aberrations with age. J Opt Soc Am A Opt Image Sci Vis. 2002;19(1):137-143.
  3. TECNIS® 1-Piece IOL [Package insert] Abbott Medical Optics Inc.
  4. Packer M, Fine IH, Hoffman RS. Functional vision, wavefront sensing, and cataract surgery. Int Ophthalmol Clin. 2003;43(2):79-91.
  5. Holladay JT, Piers PA, Koranyi G, et al. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18:683-691.
  6. Guirao A, Tejedor J, Artal P. Corneal aberrations before and after small-incision cataract surgery. Invest Ophthalmol Vis Sci. 2004;45(12):4312-4319.
  7. Mester U, Dillinger P, Anterist N. Impact of a modified optic design on visual function: clinical comparative study. J Cataract Refract Surg. 2003;29(4):652-660.
  8. Wang L, Dai E, Koch DD, Nathoo A. Optical aberrations of the human anterior cornea. J Cataract Refract Surg. 2003;29(8):1514-1521.
  9. 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.
  10. McBride DK, Matson W. Assessing the significance of optically produced reduction in braking response time: possible impacts on automotive safety among the elderly. Potomac Institute for Policy Studies. April 1, 2003.
  11. Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38:209-229.
  12. Smith G, Cox MJ, Calver R, et al. The spherical aberration of the crystalline lens of the human eye. Vision Res. 2001;41(2):235-243.
  13. Guirao A, Gonzalez C, Redondo M, et al. Average optical performance of the human eye as a function of age in a normal population. Invest Ophthalmol Vis Sci.1999;40(1):203-213.
  14. Wang L, Koch D. Ocular higher-order aberrations in individuals screened for refractive surgery. J Cataract Refract Surg. 2003;29(10);1896-1903.
  15. Holzer M, Auffarth G. Data presented at the DOC 2006.
  16. Oshika T, Klyce SD, Applegate RA, et al. Changes in corneal wavefront aberrations with aging. Invest Ophthalmol Vis Sci. 1999;40:1351-1355.
  17. Scilley K, Jackson GR, Owsley C, et al. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmol. 2002;109:1235-42.
  18. Terwee T, Van der Mooren M, Piers P. Optical Performance of TECNIS IOLs Compared with IOLs that Partly Compensate for the Mean Spherical Aberration of the Human Cornea. ASCRS 2008 Chicago
  19. Kennis H, Huygens M, Callebaut F. Comparing the contrast sensitivity of a modified prolate anterior surface IOL and of two spherical IOLs. Bull Soc Belge Ophtalmol. 2004;294:49-58.
  20. Packer M, Fine IH, Hoffman RS, Piers PA. Prospective randomized trial of an anterior surface modified prolate intraocular lens. J Refract Surg. 2002;18(6):692-696.
  21. Kershner RM. Retinal image contrast and functional visual performance with aspheric, silicone, and acrylic intraocular lenses. Prospective evaluation. J Cataract Refract Surg. 2003;29(9):1684-1694.
  22. Martinez Palmer A, Palacin Miranda B, Castilla Cespedes M, et al. [Spherical aberration influence in visual function after cataract surgery: prospective randomized trial.] Arch Soc Esp Oftalmol. 2005;80(2):71-78. Spanish language.
  23. Buell W, Menapace R, Sacu S, et al. Effect of a silicone intraocular lens with a sharp posterior edge on posterior capsule opacification. J Cataract Refract Surg. 2004;30:1661-1667.

Product Specifications TECNIS® Acrylic IOL ZA9003

Hydrophobic acrylic TECNIS® IOLs offer:

  • Designed to reduce spherical aberration to zero
  • Full transmission of visible light
  • Effective UV protection
  • Vacuole-free material
  • Proven biocompatibility20

References:

1. SRK/T
2. Holladay I
3. Values published at User Group for Laser Interference Biometry (http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm). Maintained by Wolfgang Haigis PhD, University Eye Hospital Wuerzburg (w.haigis@augenklinik.uni-wuerzburg.de). Last updated June 27, 2007. TECNIS® CL IOL Z9002 constants based on sample size 185 patients. For best results, constants should be personalized.
4. Hoffer Q
6. Value theoretically derived for a typical 20.0 D lens.

Product Specifications TECNIS® CL Silicone IOL Z9002

Next-generation silicone TECNIS® IOLs offer:

  • Designed to reduce spherical aberration to zero
  • Full transmission of visible light
  • Effective UV protection
  • Vacuole-free material
  • Proven biocompatibility20

References:

1. SRK/T
2. Holladay I
3. Values published at User Group for Laser Interference Biometry (http://www.augenklinik.uni-wuerzburg.de/ulib/c1.htm). Maintained by Wolfgang Haigis PhD, University Eye Hospital Wuerzburg (w.haigis@augenklinik.uni-wuerzburg.de). Last updated June 27, 2007. TECNIS® CL IOL Z9002 constants based on sample size 185 patients. For best results, constants should be personalized.
4. Hoffer Q
6. Value theoretically derived for a typical 20.0 D lens.

Information for consumers

For consumer information on TECNIS® IOLs please visit

               
http://www.tecnisiol.com

Important Safety Information – Tecnis® IOLs (For Physicians)

Caution:
Federal law restricts this device to sale by or on the order of a physician.

Indications:
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.

Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens.

Precautions: Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store 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.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.



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