Acry Sof Re STOR Aspheric IOL Acry Sof

Acry. Sof ® Re. STOR® Aspheric IOL

Acry. Sof ® Re. STOR® Aspheric IOL SN 6 AD 3 SN 6 AD 1 Add Power: +4 D Spectacle Plane: 3. 2 D Range: +10 D to +34 D A-Constant: 118. 9 Add Power: +3 D Spectacle Plane: 2. 4 D Range: +10 D to +34 D A-Constant: 118. 9 2

Acry. Sof ® Re. STOR® Aspheric IOL Discussion Topics • Aspheric (SN 6 AD 3) vs. Spheric (SN 60 D 3) • Introduction of SN 6 AD 1 • True performance at near, intermediate and distance • Comparison between SN 6 AD 1 and SN 6 AD 3 • High resolution image quality • Minimal visual disturbances 3

Acry. Sof ® Re. STOR® Aspheric IOL Anatomy of the Apodized Diffractive Technology Central 3. 6 mm apodized diffractive structure Step heights decrease peripherally from 1. 3 – 0. 2 microns Anterior aspheric optic A +4 D at lens plane equaling +3. 2 at spectacle plane Outer refractive zone 4

Acry. Sof ® Re. STOR® Aspheric IOL Anatomy of the Apodized Diffractive Technology 13. 0 mm Anterior Apodized Diffractive Optic 6. 0 mm Symmetric Biconvex 6. 0 mm Anterior Aspheric Optic 5

Acry. Sof ® Re. STOR® Aspheric IOL Apodization • Gradual reduction or blending of the diffractive step heights. • Optimally manages light energy delivered to the retina as it distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. • Designed to improve image quality while minimizing visual disturbances. 1. 3 micron step 6

Acry. Sof ® Re. STOR® Aspheric IOL Technology of the Acry. Sof ® Re. STOR® IOL in “Human” Terms • Thickness of a Human Hair = 60 microns • Thickness of a Red Blood Cell = 7 microns • Step Height at periphery of the diffractive portion of the Acry. Sof ® Re. STOR® Aspheric IOL = 0. 2 microns 7

Acry. Sof ® Re. STOR® Aspheric IOL Design Objective • Design considerations for the Acry. Sof ® Re. STOR® Aspheric IOL: – Induce negative Spherical Aberrations with the lens to compensate for positive corneal Spherical Aberrations 8

Acry. Sof ® Re. STOR® Aspheric IOL The Problem – Spherical Optics Marginal Rays Spherical IOL Light Rays Paraxial Rays Spherical Aberration • Spherical aberration occurs when light rays are over-refracted at the periphery of a lens system, resulting in a region of defocused light which can decrease image quality. 9 *Smith, G. , Atchinson D. A. , (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.

Acry. Sof ® Re. STOR® Aspheric IOL The Solution – Aspheric Optics Aspheric IOL Light Rays Aspheric Surface • Aspheric optics align the light rays to compensate for positive corneal spherical aberration, resulting in enhanced image quality. 10 *Smith, G. , Atchinson D. A. , (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.

Acry. Sof ® Re. STOR® Aspheric IOL (SN 6 AD 3) Specifications OPTICS 13. 0 mm 6. 0 mm Multifocal Apodized Diffractive Optic Compensation for Positive Corneal Spherical Aberration Aspheric Optic Type Proprietary Symmetric Biconvex Optic Diameter 6. 0 mm Overall Length 13. 0 mm MATERIAL Optic/Haptic Material Acry. Sof® Hydrophobic Acrylic Light Filtration UV and High-Energy Blue DESIGN IOL Design Single-Piece Haptic Design STABLEFORCE® Modified-L SPECIFICATIONS Diopter Range +10 D – +30 D in 0. 5 D increments +31 D – +34 D in 1. 0 D increments 11

Introducing Acry. Sof ® Re. STOR® Aspheric IOL +3 D

Acry. Sof ® Re. STOR® Aspheric IOL Lens Objectives • Offer an additional choice of add power • Maintain existing optical design characteristics and manufacturing processes • Without affecting visual disturbances or image contrast 13

Acry. Sof ® Re. STOR® Aspheric IOL SN 6 AD 1 Design Characteristics • Utilizes existing Re. STOR® Aspheric +4 D platform with identical asphericity, energy distribution profile, and shape factor • Modified add power from +4 D to +3 D – 9 diffractive rings vs. 12 diffractive rings – Slightly wider ring spacing to modify the add power 14

Acry. Sof ® Re. STOR® Aspheric IOL Physical Comparison +4 D, 12 zones +3 D, 9 zones • Both +4 D and +3 D have 3. 6 mm Apodized Diffractive region • +4 D central zone diameter = 0. 742 mm • +3 D central zone diameter = 0. 856 mm 15

Acry. Sof ® Re. STOR® Aspheric IOL Physical Comparison Re. STOR ® Energy Balance 4. 0 D add vs. 3. 0 D add Re. STOR® Aspheric +3 D Distance Re. STOR ® +4 D Add Distance Re. STOR® Aspheric +4 D Near Re. STOR® Aspheric +3 D Near • Diffractive step height profile and energy distribution are identical for +4 D and +3 D Re. STOR® Aspheric IOLs Data on File. Alcon, Inc. 16

Acry. Sof ® Re. STOR® Aspheric IOL Study Objective To confirm that the increase in the distance of near vision for the Re. STOR® Aspheric +3 D IOL does not negatively impact: visual acuity at near, distance, or intermediate • contrast sensitivity • halo visual disturbance scores • as compared to the Re. STOR® Aspheric +4 D IOL 17

Acry. Sof ® Re. STOR® Aspheric IOL Study Design • • • Prospective Randomized Subject masked 6 month duration with FDA submission at 3 months 300 subjects bilaterally implanted with either – Acry. Sof ® Re. STOR® Aspheric +3 D IOL Model SN 6 AD 1 – Acry. Sof ® Re. STOR® Aspheric +4 D IOL Model SN 6 AD 3 • Approximately 20 subjects at each site 18

True VA Performance • Near • Intermediate • Distance

Acry. Sof ® Re. STOR® Aspheric IOL Mean Distance VA 20/20 20/25 20/32 20/40 • Both VAs are less than one letter different 20 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Mean Near VA at Best Distance 20/20 20/25 20/32 20/40 • Both VAs are less than two letters different and both 20/25 21 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Distance in cm Mean Distance of Best Near VA • Re. STOR® Aspheric +3 D has approximately 6. 5 cm (2. 6 in) increase in distance compared to Re. STOR® Aspheric +4 D Data on File. Alcon, Inc. 22

Acry. Sof ® Re. STOR® Aspheric IOL Mean Uncorrected Intermediate VA 20/20 20/25 20/32 20/40 • VAs are approximately 1 -1. 5 line(s) better for Re. STOR® Aspheric +3 D Data on File. Alcon, Inc. 23

Acry. Sof ® Re. STOR® Aspheric IOL Mean Distance Corrected Intermediate VA 20/20 20/25 20/32 20/40 • VAs are approximately 1. 5 lines better for Re. STOR® Aspheric +3 D Data on File. Alcon, Inc. 24

Acry. Sof ® Re. STOR® Aspheric IOL Combined VA’s: Distance, Intermediate, Near 25 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Bilateral Defocus Curve Refraction (D) log. MAR 20/20 20/40 26 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Clinical Defocus Curve 27

Acry. Sof ® Re. STOR® Aspheric IOL Distance Contrast Sensitivity Mean Photopic without Glare 28 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Distance Contrast Sensitivity Mean Photopic with Glare 29 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Distance Contrast Sensitivity Mean Mesopic without Glare 30 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Distance Contrast Sensitivity Mean Mesopic with Glare 31 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Distance Image Quality in Mesopic Conditions MTF measured with model eye at 100 lp/mm. All IOL powers range from 20. 0 D to 22. 0 D Data on File. Alcon, Inc. *Trademarks are property of their respective owners. 32

Minimal Visual Disturbances

Acry. Sof ® Re. STOR® Aspheric IOL Mean Visual Disturbances None Mild Moderate Severe 34 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Mean Visual Disturbances ACRI. LISA* REZOOM* Re. STOR® Aspheric +4 D Images provided by Jim Schwiegerling at the University of Arizona *Trademarks are property of their respective owners. TECNIS* Re. STOR® Aspheric +3 D 35

Acry. Sof ® Re. STOR® Aspheric IOL Frequency of Spectacle Wear (Distance Vision) How often do you wear glasses? 36 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Frequency of Spectacle Wear (Overall) How often do you wear glasses? 37 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Percent of Subjects 96% of Re. STOR +3 Patients Would Have the Same Implant Again Would you have the same implant again? 38 Data on File. Alcon, Inc.

Acry. Sof ® Re. STOR® Aspheric IOL Conclusions • True performance at near, intermediate, and distance • Re. STOR® Aspheric +3 D IOL provides a range of near vision – Best distance approximately 7 cm out for Re. STOR® Aspheric +3 D IOL • • 1 – 1. 5 line(s) improvement in intermediate VA Aspheric optic provides improved image quality No significant differences in visual disturbances High rate of patient satisfaction and spectacle independence 39