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TECNIS ® Multifocal IOL MD to MD Speaker Presentation 2009.12.28-CT1551.

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Presentation on theme: "TECNIS ® Multifocal IOL MD to MD Speaker Presentation 2009.12.28-CT1551."— Presentation transcript:

1 TECNIS ® Multifocal IOL MD to MD Speaker Presentation CT1551

2 Overview TECNIS ® Multifocal IOL Introduction US Clinical Results The Principle of Optical Synergy Visual Acuity Comparisons Patient Selection and Implantation 2

3 The ONLY multifocal IOL that offers: Spherical aberration correction to essentially zero Better chromatic aberration reduction A pupil-independent, full-diffractive posterior surface –High-quality vision in all light conditions Clear hydrophobic acrylic –Not associated with glistenings –Full transmission of healthy blue light Next-generation one-piece design The TECNIS ® Multifocal IOL 3 TECNIS ® multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

4 The TECNIS ® Multifocal IOL US Clinical Results Nearly 90% of patients are able to function comfortably without glasses at ALL distances Nearly 9 out of 10 patients NEVER wear glasses 91.7% patient satisfaction at 1 year 92.1% simultaneous 20/25 or better distance AND 20/32 or better near At 1 year post-op, total occurrence of halos and glare showed significant improvement. 4 TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

5 TECNIS ® Multifocal Acrylic IOL 5 Posterior side Anterior side Haptics offset for 3 points of fixation 13.0 mm overall diameter Posterior diffractive surface 6.0 mm optic diameter Frosted, continuous 360° posterior square edge TECNIS ® IOL wavefront- designed aspheric surface

6 TECNIS ® Multifocal 1-Piece IOL Specifications Full diffractive posterior surface –Pupil-independent Wavefront-designed aspheric anterior surface Light distribution 50/ D to D in 0.5 D increments Optical power add +4.0 D –To optimize acuity at preferred reading distance of 33 cm Model number: ZMB00 6

7 TECNIS ® Multifocal 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 7

8 TECNIS ® Multifocal 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 8

9 TECNIS ® Multifocal 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 Anterior Posterior Tri-Fix 3-point fixation 9

10 US Clinical Results

11 Study Parameters Two multicenter, evaluator-masked comparative clinical evaluation studies with a total of 306 bilateral TECNIS ® Multifocal subjects –4-6 month study results presented for 297 bilateral multifocal and 119 bilateral monofocal subjects –One year study results presented for 292 bilateral multifocal and 114 bilateral monofocal subjects Subject assignment was not randomized –Based on patients choice for a multifocal or monofocal 11 TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

12 US Clinical Results Distance corrected binocular near visual acuity at best distance (1-year) N= TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

13 US Clinical Results Spectacle Usage (1 year) N= TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

14 US Clinical Results Combined 20/25 or better distance and 20/32 or better near (1-year) N= TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

15 US Clinical Results Ability to function comfortably without glasses (1 year) N= TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

16 Important Safety Information Important Safety Information – TECNIS ® Multifocal IOL Caution: Federal law restricts this device to sale by or on the order of a physician. (Rx only can be used in place of this text) Indications: TECNIS ® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses 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. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. 16

17 Important Safety Information Important Safety Information – TECNIS ® Multifocal IOL Precautions: The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long- term effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. 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. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Tecnis ® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2% of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction). Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. 17

18 Optical Synergy

19 Multiple Factors Affect Patient Outcomes Multiple lens design and material attributes affect quality of vision, including: –Spherical aberration correction –Chromatic aberration correction –Material clarity –Light transmission For multifocal lenses, pupil-independence also needs to be considered While each lens attribute provides an individual benefit, the total benefit of these combined attributes can create a significant visual improvement 19

20 Advantage: Correcting Spherical Aberration to Zero

21 The Average Cornea Eye (ACE) Model The average cornea eye (ACE) model was developed by collecting topography measurements from a significant sampling of cataract patients* This study concluded that the average amount of corneal spherical aberration is microns throughout life Multiple studies with over 500 patients combined confirm this data 21 *Holladay JT, et al. J Refract Surg. 2002;18:

22 Studies Validating the ACE Model 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): Holladay JT, Piers PA, Koranyi G, van der Mooren M, Norrby NE. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18(6): 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: 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): 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): Spanish language 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): 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): Piers PA. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007; 33:1721–1726. Wang L, Koch DD. Ocular higher-order aberrations in individuals screened for refractive surgery. J Cataract Refract Surg. 2003; 29: ? 22

23 Patented Wavefront-Designed Optic The TECNIS ® Multifocal aspheric surface was designed using the ACE model Provides microns of spherical aberration to correct residual spherical aberration to essentially zero* 23 *Data on file. Abbott Medical Optics Inc.

24 SA (<25 years) mean 0.02 (SD 0.052) SA (>25 years) mean (SD 0.038) Why Target Zero Spherical Aberration? Peak visual performance occurs around age At this time, the average spherical aberration of the eye is zero Spherical aberration increases with age Spherical aberration of young subjects (<25) with visual acuity better than 20/15 have zero spherical aberration on average 24 *Artal P, et al. Presented at ESCRS 2006.

25 Spherical Aberration Correction Correcting spherical aberration (SA) to zero results in sharper focus of light and therefore sharper vision at both near and distance. TECNIS ® Multifocal IOLReSTOR ® +3.0 IOL 25 * *In the average cataract patient *

26 Spherical Aberration Correction There is a measurable difference An IOL that fully corrects spherical aberration can provide a 13% increase in contrast over an IOL that leaves +0.1 residual spherical aberration* *Zhao H, et al. Presented at ESCRS Theoretical analysis. MTF measurements based on ACE cornea model, which is derived from wavefront measurements of actual cataract patients and validated by numerous studies. 26

27 Advantage: Correcting Chromatic Aberration

28 Chromatic Aberration Correction What is chromatic aberration? Occurs when light is separated into its spectral components These wavelengths refract differently, creating multiple focal points 28

29 Chromatic Aberration Correction Factors affecting chromatic aberration correction: Optic Material The chromatic aberration of optical materials can be expressed by their Abbe numbers The higher the number, the greater chromatic aberration reduction, especially for distance vision Optic Design A diffractive surface and a high add power correct for lens-induced chromatic aberration at the near focus 29

30 Chromatic Aberration Correction TECNIS ® Multifocal IOL material provides better chromatic aberration correction due to three factors: 1.Diffractive surface corrects chromatic aberration at near focus for all pupil sizes D add power corrects ocular chromatic aberration at near focus better than a +3.0 D add power 3.Material has a higher Abbe number and therefore less chromatic aberration at the distance focus* TECNIS ® Multifocal IOLReSTOR ® +3.0 IOL 30 *Zhao H. Mainster M. Br J Ophthalmol. 2007

31 Chromatic Aberration Correction AMO ® hydrophobic acrylic has the highest Abbe number of IOLs tested* This can mean up to a 12% increase in contrast compared to the AcrySof material** *Zhao H. Mainster M. J Cataract Refract Surg **Zhao H, et al. Presented at ESCRS Comparison of Abbe Numbers* 31

32 Combining Spherical and Chromatic Aberration Correction Several studies have shown the correction of chromatic aberration and spherical aberration together is more beneficial than the sum of the two individual corrections. Yoon GY, Williams DR. J Opt Soc Am A Opt Image Sci Vis. 2002;19: Manzanera S, et al. Ophthalmol Vis Sci. 2007;48:E-Abstract Zhao H, et al. Presented at ESCRS

33 Advantage: Material Clarity

34 Lathing vs. Injection Molding TECNIS ® Multifocal IOL is manufactured using a proprietary diamond cryolathing process The advantage of cryolathing over injection molded IOLs: –Ensures refractive consistency of the material –Limits microvoid formation from high temperature fluctuations, which have been shown to cause glistenings* *Miyata A, et al. J Cataract Refract Surg

35 Glistenings can cause A loss in contrast sensitivity –Eyes without glistenings were found to have a 40% increase 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** *Gunenc U, et al. J Cataract Refract Surg **Christiansen G, et al. J Cataract Refract Surg Incidence of Glistenings 35 Glistenings present in an AcrySof ® ReSTOR ® lens

36 Advantage: Blue Light Transmission

37 Blue light is proven to be essential for optimal scotopic vision* Blue light provides 35% of scotopic sensitivity* Transmission of Blue Light *Mainster MA. Br J Ophthalmol

38 Why Scotopic Sensitivity is Important Scotopic visual sensitivity decreases twice as fast with aging than photopic sensitivity* –Scotopic sensitivity decreased at a rate of 0.08 log units per decade vs log units for photopic sensitivity Scotopic vision declines with age, even in healthy eyes with no cataract or retinal problems** …so why reduce scotopic sensitivity further? 38 *Jackson GR, Owsley C. Vision Res **Mainster MA. Br J Ophthalmol

39 Better Scotopic Vision with Blue Light Transmission AMO ® hydrophobic acrylic lenses provide up to 21% more scotopic sensitivity compared to blue-blocking IOLs* *Mainster MA. Br J Ophthalmol Scotopic Sensitivity Reduction 39

40 Why Were Blue-Blocking IOLs Developed? Interest in blocking blue-light is motivated by the unproven hypothesis that phototoxicity from environmental light exposure can cause AMD* 10 of 12 major epidemiological studies show no correlation between AMD and lifelong light exposure 40 Mainster MA. Presented at ASCRS.2009.

41 The AREDs Study Results Study results show NO effect of cataract surgery on the risk of advanced AMD progression The significance of this study and the difference in these findings compared to earlier studies that reported an association can be attributed to: –Large number of participants with over 4,500 people –Follow-up length of 10 years on average –Inclusion of more people at a greater risk for AMD than population-based studies 41 Chew EY. Ophthalmology

42 What We Didnt Know The first blue-light blocking IOLs were designed prior to the discovery of the role of blue light sensitive retinal ganglion photoreceptors and their relation to melatonin suppression* –The release and suppression of melatonin affects sleep patterns, mood, memory, and systemic health Cataract surgery with a UV-blocking IOL that transmits blue light has been shown to decrease insomnia and daytime sleepiness ** 42 *Thapan K. J Physiol **Asplund. Arch Gerontol Geriatr and 2004.

43 Advantage: Pupil Independence With a Full Diffractive Surface

44 Full Diffractive Surface = Pupil Independence 44 Data on file. Abbott Medical Optics Inc. MTF measurements based on ACE cornea model, which is derived from wavefront measurements of actual cataract patients and validated by numerous studies. MTF (50c/mm) for near MTF (50c/mm) for far

45 Full Diffractive vs. Apodized Diffractive Effect in Bright Light Conditions In photopic conditions, light is distributed equally to near and distance focal points Light already begins to shift to distance at under 2mm pupil size with the apodized design TECNIS ® Multifocal IOL ReSTOR ® +3.0 IOL 45 Alfonso JF, JCRS. 2009

46 Full Diffractive vs. Apodized Diffractive Effect in Low Light Conditions As the pupil widens in mesopic conditions: TECNIS ® Multifocal IOL is pupil-independent so light is still distributed equally to near and distance focal points, retaining high-quality near vision The apodized design functions as a monofocal lens on the outer perimeter, therefore distributing more light to distance and degrading the quality of near vision TECNIS ® Multifocal IOLReSTOR ® +3.0 IOL 46

47 Light Scatter Having a posterior diffractive surface reduces the amount of internal reflections more than an anterior diffractive surface A lower refractive index reduces reflections –TECNIS ® Multifocal IOL: 1.46 RI –ReSTOR ® 3.0 IOL: 1.55 RI 47

48 Comparing Performance

49 Distance Performance 49 MTF measurements based on ACE cornea model, which is derived from wavefront measurements of actual cataract patients and validated by numerous studies. Testing was performed with polychromatic light. Data on file. Abbott Medical Optics Inc. Distance

50 Near Performance 50 MTF measurements based on ACE cornea model, which is derived from wavefront measurements of actual cataract patients and validated by numerous studies. Testing was performed with polychromatic light. Data on file. Abbott Medical Optics Inc. Near

51 Intermediate Vision TECNIS ® Multifocal IOL provides excellent intermediate vision without sacrificing near vision due to: High-quality visual acuity at near and distance focal points allow better depth of focus and therefore better vision in the intermediate range A larger central zone is designed to enhance intermediate A 89.7% spectacle independence rate at intermediate confirms that TECNIS ® Multifocal IOL patients have excellent, full range vision* 51 *TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

52 Patient Selection and Implantation

53 Patient Selection No contraindications –e.g., recurrent severe inflammation or uveitis Bilateral implantation Postoperative astigmatism <0.75 D Postoperative emmetropia or max. <0.75 D hyperopia Patient motivation (e.g., high diopter glasses, hyperopia, spectacle independence) Visual expectations of the patient 53

54 Exclusion Criteria Macular pathologies, glaucoma with severe visual field loss Monofocal IOL already in one eye (relative exclusion) Expected astigmatism > 0.75 D Expected myopia > +/- 0.5 D (in post-op spherical equivalent) Unrealistic visual expectations Happy with reading glasses Surgical complications, such as capsulorhexis tear, capsular folds, fixation in sulcus Patient is at risk for developing PCO 54

55 The One Series Ultra Implantation System Advanced control and ease-of-use Technologically advanced insertion system specifically designed for the next- generation 1-Piece IOL More controlled lens delivery using a syringe- style inserter with Y-tip plunger rod Easy-to-use, rear-loading cartridge Controlled, gentle unfolding of the lens in the eye 55

56 The One Series Ultra Implantation System Rear-loading cartridge Micro Tip: coplanar lens delivery Canopy assists in folding of leading haptic Syringe style inserter results in controlled, predictable lens delivery Snap in design locks in cartridge for secure insertion Blue Y-tip plunger rod assists lens manipulation postimplantation One Series Ultra Cartridge Inserter 56

57 In Summary TECNIS ® Multifocal IOL provides sharper vision and higher patient satisfaction by: Correction of spherical aberration to essentially zero Reduction of chromatic aberration Pupil independence with a full diffractive surface Transmission of blue light needed for scotopic vision Low incidence of glistenings High visual acuity and spectacle independence at ALL distances 57

58 References 58 Alfonso JF, Fernández-Vega L, Amhaz H, Montés-Micó R, Valcárcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg May;35(5): Artal P, Alcon E, Villegas E. Spherical aberration in young subjects with high visual acuity. Presented at ESCRS 2006, Paper 558. Asplund R, Eidervik, Linblad B. The development of sleep in persons undergoing cataract surgery. Arch Gerontol Geriatr Sep-Oct;35(2): Asplund R, Lindblad BE. Sleep and sleepiness 1 and 9 months after cataract surgery. Arch Gerontol Geriatr 2004; 38: Chew EY, Sperduto RD, Milton RC, et al. Risk of advanced age-related macular degeneration after cataract surgery: AREDS report 25. Ophthalmology2009;116: Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glistenings in the AcrySof intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27: Glasser A, Campbell MC. Presbyopia and the optical changes in the human crystalline lens with age. Vision Res. 1998;38(2): Gunenc U, Oner FH, Tongal S, et al. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. J Cataract Refract Surg Oct 2001, 27(10) p Holladay JT, Piers PA, Koranyi G, van der Mooren M, Norrby NE. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg. 2002;18(6): Jackson GR, Owsley C. Scotopic sensitivity during adulthood. Vision Res. 2000;40(18): Mainster MA, Violet and blue light blocking intraocular lenses: photoprotection vs. photoreception. Br J Ophthalmol 2006: 90;

59 References 59 Manzanera S, Piers P, Weeber H, Artal P. Visual benefi t of the combined correction of spherical and chromatic aberrations. Poster presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology; 2007 May 7; Fort Lauderdale, Florida. Available at: Accessed May 21, Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. J Cataract Refract Surg. 2004;30: Package Insert. TECNIS® Foldable Posterior Chamber Intraocular Lens. Abbott Medical Optics Inc. TECNIS Foldable Posterior Chamber Intraocular Lens [package insert]. Santa Ana, Calif. Abbott Medical Optics Inc. TECNIS Multifocal Foldable Acrylic Intraocular Lens [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc. Thapan K, Arendt J, Skene DJ. An action spectrum for melatonin suppression: evidence for a novel non-rod, non-cone photoreceptor system in humans. J Physiol. 2001;535: Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in foldable intraocular lenses. J Cataract Refract Surg. 2002;28: Yoon G, Williams DR. Visual performance after correcting the monochromatic and chromatic aberrations of the eye. J Opt Soc Am A. 2002;19: Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9): Zhao H, Piers PA, Mainster MA. The additive effects of different optical design elements contributing to contrast loss in pseudophakic eyes implanted with different aspheric IOLs. Presented at: 27th Congress of the ESCRS; 2009 Sep 4-8; Barcelona, Spain.

60 Important Safety Information Important Safety Information – TECNIS ® Multifocal IOL Caution: Federal law restricts this device to sale by or on the order of a physician. (Rx only can be used in place of this text) Indications: TECNIS ® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses 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. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions. On rare occasions these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared to a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor visibility conditions. Patients with a predicted postoperative astigmatism >1.0D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. 60

61 Important Safety Information Important Safety Information – TECNIS ® Multifocal IOL Precautions: The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1 mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible. The long- term effects of intraocular lens implantation have not been determined; therefore implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. 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. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the Tecnis ® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2% of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction). Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. 61

62 Important Safety Information Important Safety Information – DK7786 Handpiece with the One Series Ultra Cartridge Implantation System Caution: Federal law restricts this device to sale by or on the order of a physician. Indications: The DK7786 handpiece with the One Series Ultra cartridge implantation system is used to fold and assist in inserting TECNIS ® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag. Warnings: The DK7786 handpiece with the One Series Ultra cartridge implantation system should only be used with TECNIS ® 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if rod tip becomes jammed in the cartridge. Precautions: The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the AMO Healon® family of viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 5°C or over 30°C. Contraindications: Do not use the handpiece if the rod tip appears nicked or damaged in any way. AMO, TECNIS, ProTEC, Tri-Fix, and One Series are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. AcrySof and ReSTOR are trademarks of Alcon, Inc. ©2010 Abbott Medical Optics Inc. 62

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