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 TECNIS® Multifocal IOL
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
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. 3

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
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
Posterior side
Anterior side
Haptics offset for 3 points of fixation 5

6. TECNIS® Multifocal 1-Piece IOL Specifications
Tecnis Multifocal IOL Physician Presentation
TECNIS® Multifocal 1-Piece IOL Specifications
Full diffractive posterior surface
Pupil-independent
Wavefront-designed aspheric anterior surface
Light distribution 50/50
+5.0 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 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
Posterior
Tri-Fix™ 3-point fixation
Anterior 9

10. US Clinical Results

11. US Clinical Results 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 patient’s 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=290 12
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

13. Spectacle Usage (1 year)
US Clinical Results
Spectacle Usage (1 year)
N=290 13
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

14. Combined 20/25 or better distance and 20/32 or better near (1-year)
US Clinical Results
Combined 20/25 or better distance and 20/32 or better near (1-year)
N=291 14
TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc.

15. Ability to function comfortably without glasses (1 year)
US Clinical Results
Ability to function comfortably without glasses (1 year)
N=290 15
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 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
Tecnis Multifocal IOL Physician Presentation
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. 23

24. Why Target Zero Spherical Aberration?
SA (<25 years) mean (SD 0.052)
SA (>25 years) mean (SD 0.038)
Peak visual performance occurs around age 19-25
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 IOL
ReSTOR® +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*
MTF measurements based on ACE cornea model, which is derived from wavefront measurements of actual cataract patients and validated by numerous studies. 26
*Zhao H, et al. Presented at ESCRS Theoretical analysis.

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:
Diffractive surface corrects chromatic aberration at near focus for all pupil sizes
+4.0 D add power corrects ocular chromatic aberration at near focus better than a +3.0 D add power
Material has a higher Abbe number and therefore less chromatic aberration at the distance focus*
TECNIS® Multifocal IOL
ReSTOR® +3.0 IOL 30
*Zhao H. Mainster M. Br J Ophthalmol

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**
Comparison of Abbe Numbers*
*Zhao H. Mainster M. J Cataract Refract Surg. 2007
**Zhao H, et al. Presented at ESCRS 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 1513.
Zhao H, et al. Presented at ESCRS 32

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* 34
*Miyata A, et al. J Cataract Refract Surg

35. Incidence of Glistenings
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**
Glistenings present in an AcrySof® ReSTOR® lens
*Gunenc U, et al. J Cataract Refract Surg
**Christiansen G, et al. J Cataract Refract Surg 35

36. Advantage: Blue Light Transmission

37. Transmission of Blue Light
Blue light is proven to be essential for optimal scotopic vision*
Blue light provides 35% of scotopic sensitivity* 37
*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?
*Jackson GR, Owsley C. Vision Res
**Mainster MA. Br J Ophthalmol 38

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

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

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 Didn’t 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**
*Thapan K. J Physiol
**Asplund. Arch Gerontol Geriatr and 2004. 42

43. Advantage: Pupil Independence With a Full Diffractive Surface

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

45. TECNIS® Multifocal IOL
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. TECNIS® Multifocal IOL
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 IOL
ReSTOR® +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 Distance
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. 49
Data on file. Abbott Medical Optics Inc.

50. Near Performance
Near
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. 50
Data on file. Abbott Medical Optics Inc.

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 Bilateral implantation
Tecnis Multifocal IOL Physician Presentation
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 53

54. Tecnis Multifocal IOL Physician Presentation
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 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
One Series™ Ultra Cartridge
Micro Tip: coplanar lens delivery
Canopy assists in folding of leading haptic
Rear-loading cartridge
Inserter
Blue Y-tip plunger rod assists lens manipulation postimplantation
Syringe style inserter results in controlled, predictable lens delivery
Snap in design locks in cartridge for secure insertion 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
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; 58

59. References
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. 59

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