TECNIS 1-Piece IOL

1. TECNIS� 1-Piece IOL Rejuvenate Vision.

2. 2

3. TECNIS� 1-Piece IOL Overview

4. TECNIS� 1-Piece IOL - OPTICS

5. TECNIS� 1-Piece IOL - MATERIAL

6. TECNIS� 1-Piece IOL - DESIGN

7. TECNIS� 1-Piece IOL DESIGN

8. TECNIS� 1-Piece Design Benefits Ease of implantation The next-generation design Bag-friendly coplanar delivery Reduced center thickness for a slim lens profile additionally facilitates implantation Polished haptic loops reduce friction and enable controlled, gentle unfolding of the lens in the capsular bag

9. TECNIS� 1-Piece Design Benefits ProTEC� 360� Edge Design The 360� square edge is designed to limit LEC migration Uninterrupted contact with the posterior capsular bag even at the haptic-optic junction Unlike traditional single-piece designs, it prevents cell migration along the haptic The frosted-edge design minimizes edge glare

10. TECNIS� 1-Piece Design Benefits Tri-Fix� 3-Point Fixation Characterized by an offset haptic design 3-point fixation provides: Constant capsular contact Additional stability over traditional single-piece lenses Contact of sharp optic edge against the posterior capsule limits LEC migration Rapid, long-term stabilization of the optic and refraction

11. TECNIS� 1-Piece IOL OPTICAL BENEFITS

12. The Aging Eye Functional vision is reduced as the aging crystalline lens loses the ability to compensate for corneal spherical aberration*� The aging eye has positive spherical aberration Aberrations cause blurred vision and reduce contrast sensitivity and functional vision Onset of a cataract exacerbates the problem

13. The Youthful Eye Negative spherical aberration of the young crystalline lens balances positive spherical aberration of the cornea* The young eye has essentially zero spherical aberration at the age of 19** Light is sharply focused on the retina, producing a quality image and good functional vision

14. The Youthful Eye Peak visual performance occurs at 19; this is when contrast sensitivity and quality of vision peak*,�

15. Lower Spherical Aberration = Better Accommodation* Holladay explains this phenomenon by saying, �Basically, when looking at something up close, the pupil constricts, using more of the central area of the TECNIS lens. This area of the TECNIS lens has more power than available in the periphery so the near object becomes clearer.� Holladay explains this phenomenon by saying, �Basically, when looking at something up close, the pupil constricts, using more of the central area of the TECNIS lens. This area of the TECNIS lens has more power than available in the periphery so the near object becomes clearer.�

16. Target Zero Spherical Aberration The proprietary modified prolate anterior surface of TECNIS� IOLs is designed to rejuvenate vision by targeting zero spherical aberration*,� Average human cornea has +0.27 microns of spherical aberration throughout life� The TECNIS� IOL corrects for -0.27 microns of spherical aberration, similar to the crystalline lens between the ages of 19-25 TECNIS� is the first and only FDA approved IOL designed to reduce spherical aberration to 0.0�, similar to that of a 19-year old

17. Spherical Aberration Reduced to Essentially Zero*

18. High-Quality Vision With the TECNIS� IOL In aviation-type visual performance testing in the ACE model, vision in low-light conditions (5 mm pupil) was superior with TECNIS� IOL compared to a spherical IOL.�

19. Clinical Significance* Safety for drivers and others: ��there is likely to be a meaningful safety benefit for elderly drivers with TECNIS� lenses, and to the driversand pedestrians with whom they share the road.� Safety that extends beyond driving: ��the TECNIS� lens improves functional vision, which may improve patient safety for other life situations under low-visibility conditions.�

20. Proven TECNIS� Optics Approved claims by the FDA for: Reduced spherical aberration* Improved functional vision* Improved night-driving simulator performance*

21. Residual Spherical Aberration Decreases Image Quality* Residual spherical aberration of monofocal lenses (4 mm pupil)

22. Significant Improvement in MTF In one study, TECNIS� IOL shows over twice the improvement in modulation transfer function (MTF) at 100 c/mm versus AcrySof� IQ and over three times the improvement in MTF at 100 c/mm versus LI61AO and a spherical IOL.*

23. Clinical Comparison of TECNIS� Z9000, AcrySof� IQ, and SofPort� AO IOLs� Purpose: Compare aspheric IOLs with an emphasis on postoperative ocular spherical aberration and contrast sensitivity (CS) Methods: Monocular, randomized, double-masked, parallel group study (n=76) After standard phaco, patients were randomized to the SofPort AO IOL (AO), the AcrySof IQ IOL (IQ), or the Tecnis Z9000 IOL (Tecnis) Measures included pre- and postoperative BCVA, pre- and postoperative corneal topography, refraction, postoperative wavefront aberrometry, postoperative photopic (85 cd/m2) and mesopic (3 cd/m2) CS, and complications. Spherical aberrations were recorded for a 5 mm pupil. Data were collected at the 3 month postoperative visit.

24. Less Postoperative SA with TECNIS�: 5 mm Pupil�

25. Comparable Postoperative Corneal SA With Each Lens: 6 mm Pupil�

26. Significant Differences in Contrast Sensitivity: Mesopic Conditions�

27. Significant Differences in Contrast Sensitivity: Photopic Conditions�

28. Study Findings� TECNIS� IOL effectively compensates for the SA in the average eye Less SA than AO or IQ (P <.001 versus IQ) Under mesopic conditions, mean CS was significantly better with TECNIS� IOL than with AO or IQ at 3 cpd Also significantly better vs. AO at 18 cpd Under photopic conditions, mean CS was significantly better for TECNIS� vs. AO IOLs at 3 cpd and 18 cpd.

29. Section Summary Functional vision is reduced as the aging crystalline lens loses the ability to compensate for corneal spherical aberration The young eye has essentially zero spherical aberration at the age of 19 Peak visual performance occurs at 19; this is when contrast sensitivity and quality of vision peak Spherical IOLs and aspheric IOLs that induce or leave residual spherical aberration may reduce image quality TECNIS� IOLs are the only FDA approved IOLs designed to rejuvenate vision by targeting zero spherical aberration

30. TECNIS� 1-Piece IOL MATERIAL CONSIDERATIONS

31. Common Topics Involving Material Selection Calcification Glistenings Light transmission Chromatic aberration

32. Available Lens Materials PMMA Collamer Silicone Acrylic Hydrophilic acrylic Hydrophobic acrylic

33. Acrylic IOLs: Hydrophobic vs Hydrophilic Materials

34. Summary of Hydrophobic Acrylic Material

35. Summary of Hydrophilic Acrylic Material

36. Published Risks With Hydrophilics Too permeable: Highest incidence of LEC growth1 Prone to Trypan Blue Dye uptake2,3 Patients with stained IOLs had more glare3 Calcification: Propensity for calcification and opacification4 Leading cause of explant is calcification5 Decreased vision, mistiness, glare6 One thing B&L will say is that hydrophilic material is biocompatible -- or quiet in the eye. But is it too biocompatible? By absorbing its surroundings, hydrophilics have a history of LEC growth, cloudy vision, higher-than-average rate of explants, and dye-uptake. Hydrophilics also have a history of calcific deposits, leading to opacification. One thing B&L will say is that hydrophilic material is biocompatible -- or quiet in the eye. But is it too biocompatible? By absorbing its surroundings, hydrophilics have a history of LEC growth, cloudy vision, higher-than-average rate of explants, and dye-uptake. Hydrophilics also have a history of calcific deposits, leading to opacification.

37. Recent Calcification Study Purpose: To compare IOLs of different materials in the same model system for IOL calcification Method of Buchen et al, JCRS 2001;27:1473 SEM (at 500x) and EDX photos taken of central portion of IOL 3 IOLs per group implanted subcutaneously for 10 weeks in New Zealand white rabbits Hydrophilic acrylic: Akreos Fit, Akreos Adapt, Acri.Smart, Corneal, Rayner, ThinOptx, and Hydroview IOLs Hydrophobic acrylic: Sensar IOL 2nd-generation silicone: ClariFlex IOL

38. Calcification Study Results SEM showed surface delamination and pitting on hydrophilic acrylic IOLs, but not on hydrophobic acrylic or silicone IOLs EDX analysis showed distinct calcium and phosphorus peaks for the hydrophilic acrylic IOLs, but not for hydrophobic acrylic or silicone IOLs

39. Acrylic IOLs: Glistenings

40. Glistenings Formation in Hydrophobic Acrylic* Temperature changes allow water to collect within gaps formed by non-homogenous polymerization Manufacture by lathe cutting results in fewer gaps vs. molding The AMO lathe cut material has fewer gaps and is less sensitive to temperature change vs. the AcrySof� molded material The combination of injection molding and temperature sensitivity leads to significantly more glistening formation with AcrySof� IOLs

41. Clinical Significance With Glistenings Loss in contrast sensitivity A study of the effects glistenings have on visual function has shown that glistenings in AcrySof� IOLs (MA30BA and MA60BA) were related to a statistically significant loss in contrast sensitivity at high spatial frequencies* Decreased visual acuity A study has shown that eyes with higher grades of glistenings had a small but significantly greater decrease in visual acuity than those with lesser grades�

42. The Light Scatter Effect With Glistenings*

43. The Light Scatter Effect:Comparison of Acrylic Materials

44. The Light Scatter Effect:Comparison of Acrylic Materials* Initially, scatter of all IOLs was < 20yr old healthy crystalline lens Lenses with glistenings can cause scatter greater than that present in a 70 year old�s crystalline lens The forward light scatter of AcrySof� lenses is relatively large compared to the backward scatter, so functional significance may be underestimated in the clinic

45. Acrylic IOLs: The Importance of Healthy Blue Light

46. 46 IOL Light-Blocking Categories

47. IOL Light-Blocking Categories

48. IOL Comparison 48

49. To Block or Not to Block Blue Light? Blue light is not associated with AMD: 9 of 11 major epidemiological studies show no correlation between AMD and lifelong light exposure1 Factors that have been correlated with AMD are: 1) Age 2) Genetics 3) Smoking 4) Nutrition Blue light has been proven to be essential for: Optimal scotopic vision1 Healthy circadian rhythms2-4

50. Blue light provides 35% of scotopic sensitivity* Blue Light�s Affect on Scotopic Sensitivity

51. Blue-Blocking IOLs and Scotopic Sensitivity Blue-blocking IOLs reduce scotopic sensitivity by 14 to 21%1-3

52. Why Scotopic Sensitivity is Important? Scotopic visual sensitivity decreases twice as fast with aging than photopic sensitivity1 Scotopic sensitivity decreased at a rate of 0.08 log units per decade vs 0.04 log units for photopic sensitivity Scotopic vision declines with age, even in healthy eyes with no cataract or retinal problems2

53. Why Were Blue-Blocking IOLs Developed? The first blue light blocking IOLs were designed prior to the discovery of the role of retinal ganglion photoreceptors and their relation to melatonin suppression*

54. Blue Light�s Effect on Melatonin Suppression Melatonin is a key factor in controlling the body�s natural circadian rhythms* The release and suppression of melatonin affects sleep patterns, mood, memory, and systemic health* Melatonin suppression is controlled by blue light sensitive retinal ganglion cells Blue light provides 55% of melatonin suppression*

55. Acrylic IOLs: The Role of Chromatic Aberration

56. What is Chromatic Aberration? Uneven focusing of an optical system which causes wavelengths of light to have different focal points thus decreasing optical performance In order for an optical system to be optimized, it must address both monochromatic (defocus, astigmatism, and higher order aberrations) and chromatic aberration

57. How Do We Measure Chromatic Aberration? Chromatic aberration from IOLs may negatively impact: Visual acuity Contrast sensitivity Functional vision The chromatic aberration of optical materials can be expressed by their Abbe numbers The higher the Abbe number the lower the chromatic aberration and the higher the retinal image quality

58. Material Comparison A higher Abbe number is better: this means less chromatic aberration and better optical performance1,2

59. Clinical Significance of a Higher Abbe Number Lower chromatic aberration vs. AcrySof� hydrophobic acrylic and less than the average young crystalline lens

60. Summary of Material Considerations Available lens materials include: PMMA, Collamer, Silicone, and Acrylic with acrylic as the most commonly selected Common material concerns include: calcification, glistenings, light transmission, and chromatic aberration AMO hydrophobic acrylic effectively responds to these concerns and often outperforms other competitive materials as evidenced by: No calcification or opacification as found with hydrophilic acrylic IOLs A proprietary cryo-lathing process that limits the occurrence of glistenings vs. AcrySof acrylic material Full transmission of healthy blue light for Better scotopic sensitivity Optimal circadian rhythms Lower chromatic aberration vs. AcrySof hydrophobic acrylic and less than the average young crystalline lens

61. US Clinical Study 1-Year Data

62. 62 Spherical 1-Piece US Study:Cohort Description US study conducted with the spherical version of the 1-piece lens 123 Subjects Gender: 43.1% male, 56.9 % female Mean Age: 71.9 (� 8.5SD) - ranged from 48 to 94 years 6 investigational sites Emmetropia (plano � 0.25D) was the targeted refraction for all but three subjects

63. 63 Spherical 1-Piece IOL:Uncorrected Distance Visual Acuity

64. 64 Spherical 1-Piece IOL:Best Corrected Distance Visual Acuity

65. 65 Spherical 1-Piece Clinical Study:Analysis of Safety Adverse Events Four subjects developed CME during the course of the study for a cumulative CME rate of 3.3% (4/123) One subject had persistent CME at one year for a rate of 0.9% (1/117) One subject underwent a lens exchange secondary to torn haptic (related to improper folding) One subject underwent a pars plana vitrectomy with an epiretinal membrane peel No unanticipated adverse device effects No lens complications

66. 66 Spherical 1-Piece Clinical Study:Summary and Conclusions 91.5% of all subjects were 20/40 or better uncorrected for distance 100% of all subjects achieved BCDVA of 20/40 or better No lens complications occurred during the investigation

67. 67 In Summary Next generation one-piece design 3-point fixation for stability 360-degree barrier protection Bag-friendly coplanar design Same TECNIS� Optic Reduces spherical aberration to essentially zero Proprietary FDA-approved material Transmits healthy blue light Lowest chromatic aberration and highest optical throughput No glistenings or calcification issues

68. 68 References Abela-Formanek C, et al. Uveal and capsular biocompatibility of hydrophilic acrylic, hydrophobic acrylic, and silicone intraocular lenses. J Cataract Refract Surg. 2002;28(1):50-61. Artal P,�Alc�n 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. Asplund R, Eidervik Lindblad B. The development of sleep in persons undergoing cataract surgery. Arch Gerontol Geriatr. 2002;35(2):179-187. Asplund R, Lindblad BE. Sleep and sleepiness 1 and 9 months after cataract surgery.�Arch Gerontol Geriatr. 2004;38:69-75. Balasubramaniam C, Goodfellow J, Price N, Kirkpatrick N. Opacification of the Hydroview H60M intraocular lens: total patient recall. J Cataract Refract Surg. 2006;32(6):944-948. Bisol T, Rezende RA, Guedes J, Dantas AM. Effect of blue staining of expandable hydrophilic intraocular lenses on contrast sensitivity and glare vision. J Cataract Refract Surg. 2004;30(8):1732-1735. Buchen SY, Cunanan CM, Gwon A, et al. Assessing intraocular lens calcification in an animal model. J Cataract Refract Surg. 2001;27:1473-1484. Cajochen C, Jud C, Munch M. Evening exposure to blue light stimulates the expression of the clock gene PER2 in humans. Eur J Neurosci. 2006:PP-1-5. Charman WN. Age, lens transmittance and the possible effects of light on melatonin suppression. Ophthalmol Physiol Opt. 2003;23(2):181-187. Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glistenings in the AcrySof intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27:728-733.

69. 69 References Chu R. Targeting Zero Spherical Aberration With Optimal Lens Selection And Pseudophakic Management. Presented at the ESCRS, 2007. Dogru M, Tetsumoto K, Tagami Y, et al. Optical and atomic force microscopy of an explanted AcrySof intraocular lens with glistenings. J Cataract Refract Surg. 2000;26:571-575. Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38(2):209-229. Gregori NZ, Spencer TS, Mamalis N, Olson RJ. In vitro comparison of glistening formation among hydrophobic acrylic intraocular lenses(1). J Cataract Refract Surg. 2002;28(7):1262-1268. 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. Gunenc U, Oner FH, Tongal S, Ferliel M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. J Cataract Refract Surg. 2001;27:1611-1614. 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(6):683-691. Holzer MP. Data presented at the19th Congress of German Ophthalmic Surgeons (DOC), Nuremburg, Germany, 2006. Jackson GR. Pilot study on the effect of a blue-blocking IOL on rod-mediated (scotopic) vision. ASCRS Symposium on Cataract, IOL and Refractive Surgery, Washington, DC, 2005. 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.

70. 70 References Lehrl S, Gerstmeyer J, Jacob H. Blue light improves cognitive performance. J Neural Trans. 2007;114(4):457-460. Mainster MA. Violet and blue light blocking intraocular lenses: photoprotection vs. photoreception. Br J Ophthalmol. 2006;90:784-792. Mainster MA, Turner PL. The impact of blue light on vision & health. Presented at ASCRS, 2007. McBride DK, Matson W. Preliminary report PIPS-50-03. Arlington, VA: Potomac Institute for Policy Studies; April 1, 2003. Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg. 2004;30:1768-1772. Munch M., Kobialka S., Steiner R., Wavelength-dependent effects of evening light exposure on sleep architecture and sleep EEG power density in men. Am J Physiol. 2006;290:1421-1428. Negishi K, Ohnumna K, Hirayama N, Noda T. Effect of chromatic aberration on contrast sensitivity in pseudophakic eyes. Arch Ophthalmol. 2001;119:1154-1158. Nishi T, Nawa Y, Ueda T, et al. Effect of total higher-order aberrations on accommodation in pseudophakic eyes. J Cataract Refract Surg. 2006;32(10):1643-1649. Oshika T, Klyce SD, Applegate RA, et al. Changes in corneal wavefront aberrations with aging. Invest Ophthalmol Vis Sci. 1999;40:1351-1355. Owsley C, Sekuler R, Siemsen D. Contrast sensitivity throughout adulthood. Vision Res.1983;23(7):689-699. Ozbek Z, Saatci AO, Durak I, et al. Staining of intraocular lenses with various dyes: A study of digital image analysis. Ophthalmologica. 2004;218:243-247. Packer M, Fine IH, Hoffman RS. Functional vision, wavefront sensing, and cataract surgery.Int Ophthalmol Clin. 2003;43(2):79-91.

71. 71 References �� Piers PA, Tabernero J, Benito A, et al. Optical and visual performance are well correlated in pseudophakic eyes. Presented at ASCRS 2005. Schwiegerling J. Theoretical limits to visual performance. Surv Ophthalmology. 2000;45(2):139-146. Schwiegerling J.� Blue-light-absorbing lenses and their effect on scotopic vision.� J Cataract Refract Surg. 2006;32:141-144. Scilley K, Jackson G, Cideciyan A, et al. Early Age-related Maculopathy and Self-reported Visual Difficulty in Daily Life. Ophthalmology. 2002;109(7):1235-1242. Steinert RR. In vivo assessment of intraocular lens calcification in a rabbit model. Presented at ASCRS, 2006. Tehrani M, Mamalis N, Wallin T, et al. Late postoperative opacification of MemoryLens hydrophilic acrylic intraocular lenses: case series and review. J Cataract Refract Surg. 2004;30(1):115-122. Erratum in: J Cataract Refract Surg. 2004;30(7):1391. Thapan K, Aredt J, Skene DJ. An Action Spectrum for Melatonin Suppression: Evidence for a Novel Non-Rod, Non-Cone Photorecpetor System in Humans. J Physiol. 2001;535:261-267.�� Waite A, Faulkner N, Olson RJ. Glistenings in the single-piece, hydrophobic, acrylic intraocular lenses. Am J Ophthalmol. 2007;144:143-144. Wang L, Dai E, Koch DD, Nathoo A. Optical aberrations of the human anterior cornea. J Cataract Refract Surg. 2003;29(8):1514-1521. Werner J S. Night vision in the elderly: consequences for seeing through a ��blue filtering�� intraocular lens. Br J Ophthalmol. 2005;89:1518�1521. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9):1225-1229.

72. Indications TECNIS� foldable intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lenses are intended to be placed in the capsular bag. Rx Only. Precautions: Do not resterilize the lens; do not soak or rinse the lens with any solution other than sterile saline solution; do not store the lens in direct sunlight. Warnings: Surgeons should consider the risk/benefit ratio for adults with preoperative ocular pathology, including but not limited to inflammation, distorted eye and microbial infection. Adverse Events: Adverse events that have been documented as having occurred following intraocular lens implantation include, but are not limited to, corneal edema, iritis, lens dislocation, hyphema, macular edema, and retinal detachment. For a complete listing of precautions, warnings and adverse events, refer to the package insert.  TECNIS and the AMO logo are registered trademarks, and ProTEC and Tri-Fix are trademarks of Advanced Medical Optics, Inc. AcrySof is a trademark of Alcon, Inc.