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Important Safety Information – TECNIS® 1-Piece IOL

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

Indications:
TECNIS® 1-piece 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: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

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

TECNIS<sup>®</sup> 1-Piece IOL

TECNIS® 1-piece 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.

IT'S THE ONE WITH THE NEXT-GENERATION DESIGN

ProTEC 360° edge design increases protection

1 2
360° square edge for uninterrupted contact at the haptic-optic junction Frosted edge designed to minimize unwanted edge glare
AcrySof®** IOL TECNIS® 1-Piece IOL
3 4
Limits LEC migration at the haptic-optic junction24

**AcrySof is a trademark of Novartis International AG

Tri-Fix 3-Point Fixation designed to increase stability

Tri-Fix Design

5

  • Haptics offset allows three points of capsular bag fixation
  • Provides refractive predictability, long-term stability, and centration

TECNIS® 1-Piece IOL provides ease of implantation

  • Bag-friendly, coplanar delivery
  • Proprietary surface treatment for ease of unfolding
Haptic Loops Slim Lens Profile
6 7
Polished haptic loops enable controlled, gentle unfolding in capsular bag Reduced center thickness for slim lens profile facilitates implantation

Lens Features

The TECNIS® IOL is proven to:
     
  • Reduce spherical aberration3
  •  
  • Improve functional vision3
  •  
  • Improve night driving simulator performance3

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

Improved Functional Vision

TECNIS® IOL is likely to provide a meaningful safety benefit to elderly drivers3,10

                                           

simulated night-driving study

In a simulated night-driving study, at 55 mph the TECNIS® Monofocal 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 the 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® 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

Competitive Advantage

Other IOLs (both spherical and   aspheric) are designed to 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
Residual Spherical Aberration (SA) of Monofocal Lenses (4 mm   pupil)
*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.

A clinical study conducted in 2002 and summarized in the labeling did not demonstrate a statistically significant improvement in contrast sensitivity.

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 Moreover, LI61AO   performs similarly to a spherical lens.

                                             
MTF Comparison of Lens Models (5 mm pupil)18
MTF Comparison of Lens Models (5 mm pupil)

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

Proven Hydrophobic Material

IT'S THE ONE WITH PROVEN HYDROPHOBIC ACRYLIC MATERIAL

There is no reason to block blue light

     
  • Blocking blue light does not provide any proven benefit, and increases the risk of compromising scotopic vision and normal circadian rhythms.25
  • Furthermore, multiple peer-reviewed studies have failed to find a link between age-related macular degeneration (AMD) and blue light exposure.25

Healthy blue light transmission is necessary for optimal scotopic vision25

                                     
Blue light provides 35%
       of scotopic sensitivity
25
Blue-blocking IOLs reduce
       scotopic sensitivity up to 21%
25

1

     
  • Scotopic vision declines with age, even in healthy eyes without cataract or retinal disease.25  
  • Driving, mobility and peripheral vision problems have all been associated with reduced scotopic vision.26

Blue light is essential for healthy circadian rhythms25

                               
Blue light is responsible for 55% of melatonin suppression25

3

     
  • Circadian rhythms are normal 24-hour cyclic activities in the body that influence sleep pattern, mood, alertness, and body temperature.25  
  • Blue light helps regulate melatonin levels which influence circadian rhythms.25  

BETTER MATERIAL REDUCES CHROMATIC ABERRATION

What is chromatic aberration?

                                     

Chromatic Aberration Present

Chromatic Aberration Corrected
4
     
  • Chromatic aberration is the uneven focusing of an optical system that causes different wavelengths of light to have different focal points.27  
  • Chromatic aberration of optical materials can be expressed by their Abbe number.  

BETTER MATERIAL NOT ASSOCIATED WITH GLISTENINGS AND CALCIFICATION  

     
  • Temperature fluctuations of other IOLs have been shown to cause glistening formation.28  
  • TECNIS® IOLs are made with a proprietary cryo-lathing method that limits microvoid formation and high temperature fluctuations for reduced glistening formation.28  
  • The TECNIS® 1-Piece hydrophobic acrylic material is not associated with calcification and opacification found in hydrophilic acrylic IOLs.29
                                                                                                     
Material issues associated with competitive IOLs

6

7
AcrySof®** IOL implant after 1 year AcrySof®** IOL implant after 2 years
89
Hydrophilic Acrylic Material TECNIS® 1-Piece Hydrophobic
       Acrylic Material

**AcrySof is a trademark of Novartis International AG

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. The 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.
  24. Nixon. J Cataract Refract Surg. 2010; 36:929-924
  25. Mainster MA. Violet and blue light blocking intraocular lenses: Photoprotection vs. photoreception. Br J Ophthalmol. 2006;90:784-792.
  26. Owsley C, McGwin G, Scilley K, et al. Perceived barriers to care and attitudes about vision and eye care: Focus groups with older African Americans and eye care providers. Invest Ophth Vis Sci. 2006;47(4):2797-2802.
  27. Schwiegerling J. Theoretical limits to visual performance. Surv Ophthalmology. 2000;45(2):139-146.
  28. Data on file 150.
  29. Colin J, Praud D, Touboul D, Schweitzer C. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. J Cataract Refract Surg. 2012;38(7):1140-6.

Specifications

 

TECNIS® 1-Piece IOL

                                                 
1
2            
 

1. Value theoretically derived for a typical   20.0 D lens. AMO recommends that surgeons personalize their A-constant based on   their surgical techniques and equipment, experience with the lens model, and   post-operative results. 2. Calculated based on Holladay I   formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A   three-part system for refining intraocular lens power calculations. J   Cataract Refract Surg. 1988;14(1):17-24).

Information for consumers

For consumer information on TECNIS® IOLs please visit

               
Tecnisiol Website
http://tecnisiol.com/us/patient

Important Safety Information – TECNIS® 1-Piece IOL

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

Indications:
TECNIS® 1-piece 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: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

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



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