Start with ME. TECNIS MONOFOCAL IOL WITH TECNIS itec PRELOADED DELIVERY SYSTEM LEAVE YOUR LEGACY OF EXCELLENT OUTCOMES WITH PEACE OF MIND.

Transcription

1 LEAVE YOUR LEGACY OF EXCELLENT OUTCOMES WITH PEACE OF MIND. Start with ME. WITH INDICATIONS: AMO 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. itec PRELOADED DELIVERY SYSTEM

2 WITH VISION FUNCTIONALITY SUSTINABILITY THE LEGACY YOU LEAVE IS THE LIFE YOUR PATIENTS LIVE. And it begins with your choice. itec PRELOADED DELIVERY SYSTEM The IOL you choose is the one thing left behind after cataract surgery. It s the vision your patients take with them and the peace of mind you feel in the operating room. With the Monofocal 1-Piece IOL and TECNIS itec Preloaded Delivery System, you can give your patients sharp vision, enhanced functionality and long-term sustainability and give yourself peace of mind by having safety and efficiency in every procedure. pg 2

3 WITH VISION FUNCTIONALITY SUSTINABILITY START YOUR LEGACY OF EXCELLENT OUTCOMES WITH STERILE, CONTROLLED AND TOUCH-FREE IOL DELIVERY. 1 PLUNGER MARKINGS Provides clear guidance to ensure consistent delivery BEVEL TIP Enables planar delivery via 2.2 mm 2.4 mm incision CLEAR CARTRIDGE Facilitates visual check of IOL and OVD PRODUCT LABELING Allows verification of model and power prior to implantation SCREW-STYLE INSERTION MECHANISM Ensures consistent, controlled advance and IOL delivery 1. The 1-Piece IOL with the TECNIS itec Preloaded Delivery System Directions for Use. Z310911P Rev E. Abbott Medical Optics Inc., REF2015CT0250. pg 3

4 WITH VISION FUNCTIONALITY SUSTINABILITY TECNIS itec PRELOADED DELIVERY SYSTEM itec PRELOADED DELIVERY SYSTEM Preloaded with Monofocal 1-Piece IOL 2.2 mm 2.4 mm incision across all diopters Screw-style insertion Available in the full diopter range (5.0 D to 34.0 D) in 0.5 D steps Not made with natural rubber latex pg 4

5 WITH VISION FUNCTIONALITY SUSTINABILITY Why haven t more cataract surgeons adopted a PRELOADED IOL DELIVERY SYSTEM? Requirements for success include all of the following: VISION SUSTAINABILITY SAFETY & EFFICIENCY All of this must add up to a platform that consistently delivers peace of mind to the physician and staff. pg 5

6 WITH VISION FUNCTIONALITY SUSTINABILITY WITH Excellent outcomes with peace of mind. SAFETY & EFFICIENCY? 70% of patients had best corrected binocular distance visual acuities 20/16 or better with ZCB % of patients had best corrected binocular distance visual acuities 20/20 or better with ZCB00 1 IOLs provide 14 35% improved image contrast compared to AcrySof IQ IOL from chromatic aberration reduction and correction of spherical aberration to essentially zero 2 13% loss of simulated image contrast for the AcrySof IQ IOL relative to the performance of lenses, which correct the SA of the average eye to essentially 0 microns 3 Material dispersions with Abbe numbers of 37 result in a 12% loss relative to an Abbe number of Data on File Key clinical outcomes from the IDE clinical study of the TECNIS Multifocal low-add 1-Piece IOL - Abbott Medical Optics Inc., DOF 2015CT0015, 2. Data on File TECNIS Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data - Abbott Medical Optics Inc., 8 May DOF2015CT Zhao H, et al. 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; Paris, France. REF2014MLT0020. pg 6

7 WITH VISION FUNCTIONALITY SUSTINABILITY WITH Excellent outcomes with peace of mind. SAFETY & EFFICIENCY? IOL material is not associated with glistenings 1 AcrySof IQ IOLs have glistenings 2-6 Glistenings cause light scatter, which can result in a reduction in image contrast 7-9 ProTEC 360 barrier edge for reduced LEC migration 10,11 1. Data on File 150 Sensar not associated with glistenings Literature analysis. Abbott Medical Optics Inc., REF2014OTH Christiansen G, et al. Glistenings in the AcrySof intraocular lens: Pilot study. JCRS 2001;27: REF2014MLT Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. JCRS 2012; 38: REF2014MLT Gunenc U, et al M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. JCRS 2001; 27: REF2014MLT Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS 2010; 36: REF2015CT van der Mooren M, et al. Effects of glistenings in intraocular lenses. Biomedical Optics Express. 11 July 2013: REF2014OTH Bousquet M, PhD, Health Canada. Intraocular lenses and the development of glistenings. Canadian Adverse Reaction Newsletter REF2015CT Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. JCRS 2004; 30: REF2014OTH van der Mooren M, et al. Explanted multifocal intraocular lenses. JCRS 2015; 41: REF2015OTH Nixon DR. New technologies for premium outcomes: next generation phaco and 1-Piece IOL. Presented at: 25th Congress of ESCRS; September 8 12,2007; Stockholm, Sweden. REF2014CT Kugelberg M, Wejde G, Jayaram H, Zetterström C. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow-up. JCRS 2006;32(10): REF2014CT0096. pg 7

8 WITH VISION FUNCTIONALITY SUSTINABILITY WITH Excellent outcomes for life, with peace of mind. SAFETY & EFFICIENCY? Minimises risks of infection associated with contamination 1 Eliminates IOL touches 1 Eliminates loading errors 2 Saves time In a recent multi-centre observational study, results with the TECNIS itec Preloaded Delivery System projected: Improves case throughput 1 1 additional surgery per day 1 Up to 10% increase in annual throughput of cases 1 Up to 12% reduction in total case time 1 Up to 44% reduction in total surgeon lens time 1 1. Data on File Evaluating the Operational and Economic Impact of the itec Preloaded IOL Delivery System. REF2015CT The 1-Piece IOL with the TECNIS itec Preloaded Delivery System DFU doc. #Z310911P Rev E. REF2015CT0250. pg 8

9 WITH VISION FUNCTIONALITY SUSTINABILITY LEAVE A LEGACY OF EXCELLENT OUTCOMES. CHOOSE AN IOL THAT DELIVERS THE VISION pg 9

10 WITH VISION FUNCTIONALITY SUSTINABILITY WITH 20/16 or better visual acuity* in 70 % of patients 1 BINOCULAR BEST CORRECTED VISUAL ACUITY AT 6 MONTHS 1 MONOFOCAL 1-PIECE IOL: ZCB00 VISUAL ACUITY UNCORRECTED BEST CORRECTED 20/16 or Better 42.5% 69.9% 20/20 or Better 75.3% 95.9% 20/20 or better visual acuity* in 96 % of patients 1 20/25 or Better 91.1% 100% 20/32 or Better 96.6% 100% 20/40 or Better 99.3% 100% 20/50 20/80 0.7% 0.0% 20/100 or Worse 0.0% 0.0% * Best corrected binocular distance 1. Data on File Key clinical outcomes from the IDE clinical study of the TECNIS Multifocal low-add 1-Piece IOL - Abbott Medical Optics Inc., DOF 2015CT0015. pg 10

11 WITH VISION FUNCTIONALITY SUSTINABILITY WITH Monofocal 1-Piece IOL provides 14-35% improved image contrast compared to the AcrySof IQ IOL from chromatic aberration reduction and correcting spherical aberration to essentially zero. 1 BEST-FOCUS MTF* BEST-FOCUS MTF White Light MTF (50 c/mm) 14% MTF at 50 c/mm % Monofocal (ZCB00) AcrySof (SN60WF) mm 5 mm Pupil Size TECNIS Monofocal (ZCB00) AcrySof (SN60WF) * Modular Transfer Function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast. 1. Data on File TECNIS Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data - Abbott Medical Optics Inc., 8 May DOF2015CT0016. pg 11

12 WITH SAFETY & EFFICIENCY? LEAVE A LASTING LEGACY. CHOOSE IOLs THAT DELIVER SUSTAINABILITY pg 12

13 WITH SAFETY & EFFICIENCY? IOL MATERIAL is not associated with glistenings 1 VS AcrySof IOLs have glistenings X 40X GLISTENINGS CAUSE LIGHT SCATTER which can result in reduction in image contrast 6-8 DARK FIELD IMAGES OF AcrySof LENS 9 1. Data on File 150 Sensar not associated with glistenings Literature analysis. Abbott Medical Optics Inc., REF2014OTH Christiansen G, et al. Glistenings in the AcrySof intraocular lens: Pilot study. JCRS 2001;27: REF2014MLT Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. JCRS 2012; 38: REF2014MLT Gunenc U, et al M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. JCRS 2001; 27: REF2014MLT Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS 2010; 36: REF2015CT Bousquet M, PhD, Health Canada. Intraocular lenses and the development of glistenings. Canadian Adverse Reaction Newsletter REF2015CT Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. JCRS 2004; 30: REF2014OTH van der Mooren M, et al. Explanted multifocal intraocular lenses. JCRS 2015; 41: REF2015OTH van der Mooren M, et al. Effects of glistenings in intraocular lenses. Biomedical Optics Express. 11 July 2013: REF2014OTH0139. pg 13

14 WITH SAFETY & EFFICIENCY? CHOOSE A PRELOADED SYSTEM THAT OFFERS SAFETY & EFFICIENCY pg 14

15 WITH SAFETY & EFFICIENCY? SAFETY & EFFICIENCY? MINIMISE THE RISK OF INFECTION AND INFLAMMATION associated with lens contamination 1 ELIMINATE IOL TOUCHES there s no need to directly touch the lens outside of the eye 1 ELIMINATE LOADING ERRORS 2 1. Data on File Evaluating the Operational and Economic Impact of the itec Preloaded IOL Delivery System. REF2015CT The TECNIS 1-Piece IOL with the TECNIS itec Preloaded Delivery System Z310911P Rev E. REF2015CT0250. pg 15

16 WITH SAFETY & EFFICIENCY? SAFETY & EFFICIENCY? MEAN TOTAL CASE TIMES BY STUDY SITE 1 35 MEAN TOTAL CASE TIMES BY STUDY SITE UP TO 12% REDUCTION IN TOTAL CASE TIME. 1 Total Case Time Min. (mean) % -6.2% -9.4% Manual TECNIS itec 0 Canada France U.S.A. Study Sites Reduced Total Case Time Across all study sites, use of the TECNIS itec Preloaded Delivery System led to statistically significant reductions in total case times of -12.0%, -6.2%, and -9.4% in Canada, France and the U.S.A. respectively Data on File Evaluating the Operational and Economic Impact of the itec Preloaded IOL Delivery System. REF2015CT0200. pg 16

17 WITH SAFETY & EFFICIENCY? SAFETY & EFFICIENCY? TOTAL SURGEON LENS TIMES BY STUDY SITE* 1 UP TO 44% REDUCTION IN TOTAL SURGEON TIME. 1 SITE CANADA FRANCE U.S.A. Surgery Activity Total Surgeon Lens Time Total Surgeon Lens Time Total Surgeon Lens Time Reduced Total Surgeon Lens Time Manual TECNIS itec Diff Diff (%) P-Value 0:01:43 0:00:58-0:00: % < :01:09 0:00:47-0:00: % < :02:01 0:01:40-0:00: % <0.001 The TECNIS itec Preloaded Delivery System reduces serial steps and eliminates manual lens loading, resulting in significant total surgeon lens time reduction across study sites. * Total surgeon lens time is defined as the time the surgeon spends loading, inserting, and positioning the lens in the eye. 1. Data on File Evaluating the Operational and Economic Impact of the itec Preloaded IOL Delivery System. REF2015CT0200. pg 17

18 WITH SAFETY & EFFICIENCY? SAFETY & EFFICIENCY? Save time and money with streamlined inventory management: No injectors required No need for separate cartridge inventories PROJECTED 1 ADDITIONAL SURGERY PER DAY* 1 PROJECTED UP TO 10% INCREASE IN ANNUAL THROUGHPUT OF CASES* 1 * Individual results may vary. 1. Data on File Evaluating the Operational and Economic Impact of the itec Preloaded IOL Delivery System. REF2015CT0200. pg 18

19 WITH ENHANCED FUNCTIONALITY? LEAVE YOUR LEGACY OF EXCELLENT OUTCOMES FOR LIFE WITH THE MONOFOCAL 1-PIECE IOL pg 19

20 WITH ENHANCED FUNCTIONALITY? Excellent outcomes for life ENHANCED FUNCTIONALITY? 70% of patients had best corrected binocular distance visual acuities 20/16 or better with ZCB % of patients had best corrected binocular distance visual acuities 20/20 or better with ZCB00 1 IOLs provide 14 35% improved image contrast compared to AcrySof IQ IOL from chromatic aberration reduction and correction of spherical aberration to essentially zero 2 13% loss of simulated image contrast for the AcrySof IQ IOL relative to the performance of lenses, which correct the SA of the average eye to essentially 0 microns 3 Material dispersions with an Abbe # of 37 results in a 12% loss of simulated image contrast relative to an Abbe # of Data on File Key clinical outcomes from the IDE clinical study of the Multifocal low-add 1-Piece IOL. Abbott Medical Optics Inc., DOF 2015CT Data on File - Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data. Abbott Medical Optics Inc., 8 May DOF 2015CT Zhao H, et al. 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; Paris, France. REF2014MLT0020. pg 20

21 WITH ENHANCED FUNCTIONALITY? Excellent outcomes for life ENHANCED FUNCTIONALITY? Improved patient safety under low-visibility conditions 1 There is likely to be a meaningful safety benefit for elderly drivers with IOLs and to the drivers and pedestrians with whom they share the road 1 Safety that may extend beyond driving: the IOL improves functional vision, which may improve patient safety for other life situations under low-visibility conditions 1 Improved low-light optical performance 2 1-Piece Monofocal IOL demonstrates 35% improvement in image contrast with large pupil (5 mm) vs. AcrySof IQ IOL Piece IOLs DfU - Doc. #Z310719P_Rev B. REF2014CT Data on File TECNIS Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data - Abbott Medical Optics Inc., 8 May DOF2015CT0016. pg 21

22 WITH ENHANCED FUNCTIONALITY? Excellent outcomes for life ENHANCED FUNCTIONALITY? IOL material is not associated with glistenings 1 AcrySof IQ IOLs have glistenings 2-6 Glistenings cause light scatter, which can result in a reduction in image contrast 7-9 ProTEC 360 barrier edge for reduced LEC migration 10,11 1. Data on File 150 Sensar not associated with glistenings Literature analysis. Abbott Medical Optics Inc., REF2014OTH Christiansen G, et al. Glistenings in the AcrySof intraocular lens: Pilot study. JCRS 2001;27: REF2014MLT Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. JCRS 2012; 38: REF2014MLT Gunenc U, et al M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. JCRS 2001; 27: REF2014MLT Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS 2010; 36: REF2015CT van der Mooren M, et al. Effects of glistenings in intraocular lenses. Biomedical Optics Express. 11 July 2013: REF2014OTH Bousquet M, PhD, Health Canada. Intraocular lenses and the development of glistenings. Canadian Adverse Reaction Newsletter REF2015CT Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. JCRS 2004; 30: REF2014OTH van der Mooren M, et al. Explanted multifocal intraocular lenses. JCRS 2015; 41: REF2015OTH Nixon DR. New technologies for premium outcomes: next generation phaco and 1-Piece IOL. Presented at: 25th Congress of ESCRS; September 8 12,2007; Stockholm, Sweden. REF2014CT Kugelberg M, Wejde G, Jayaram H, Zetterström C. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow-up. JCRS 2006;32(10): REF2014CT0096. pg 22

23 WITH ENHANCED FUNCTIONALITY? GIVE YOUR PATIENTS THE IOLs THAT DELIVER THE VISION pg 23

24 WITH ENHANCED FUNCTIONALITY? 20/16 or better visual acuity* in 70 % of patients 1 BINOCULAR BEST CORRECTED VISUAL ACUITY AT 6 MONTHS 1 MONOFOCAL 1-PIECE IOL: ZCB00 VISUAL ACUITY UNCORRECTED BEST CORRECTED 20/16 or Better 42.5% 69.9% 20/20 or Better 75.3% 95.9% 20/25 or Better 91.1% 100% 20/20 or better visual acuity* in 96 % of patients 1 20/32 or Better 96.6% 100% 20/40 or Better 99.3% 100% 20/50 20/80 0.7% 0.0% 20/100 or Worse 0.0% 0.0% * Best corrected binocular distance. 1. Data on File Key clinical outcomes from the IDE clinical study of the Multifocal low-add 1-Piece IOL - Abbott Medical Optics Inc., DOF 2015CT0015. pg 24

25 WITH ENHANCED FUNCTIONALITY? Monofocal 1-Piece IOL provides 14-35% improved image contrast compared to the AcrySof IQ IOL, from chromatic aberration reduction and correcting spherical aberration to essentially zero. 1 BEST-FOCUS MTF* BEST-FOCUS MTF White Light MTF (50 c/mm) 14% MTF at 50 c/mm % Monofocal (ZCB00) AcrySof (SN60WF) mm 5 mm Pupil Size TECNIS Monofocal (ZCB00) AcrySof (SN60WF) * Modular Transfer Function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast. 1. Data on File Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data - Abbott Medical Optics Inc., 8 May DOF2015CT0016. pg 25

26 WITH ENHANCED FUNCTIONALITY? LEAVE A LEGACY THAT EMPOWERS YOUR PATIENTS WITH ENHANCED FUNCTIONALITY pg 26

27 WITH ENHANCED FUNCTIONALITY? ENHANCED FUNCTIONALITY? Improved patient safety under low-visibility conditions for driving and beyond 1 There is likely to be a meaningful safety benefit for elderly drivers with IOLs, and to the drivers and pedestrians with whom they share the road 1 Safety that may extend beyond driving: The IOL improves functional vision, which may improve patient safety for other life situations under low-visibility conditions Piece IOLs DfU - Doc. #Z310719P_Rev B. REF2014CT0477. pg 27

28 WITH ENHANCED FUNCTIONALITY? ENHANCED FUNCTIONALITY? The Monofocal 1-Piece IOL demonstrates 35% improvement in image contrast with large pupil (5mm) vs. AcrySof IOL. 1 BEST-FOCUS MTF* White Light MTF (50 c/mm) 0.50 MTF at 50 c/m m % Monofocal (ZCB00) AcrySo f (SN60WF) mm 5 mm Pupil Size * Modular Transfer Function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast. 1. Data on File Monofocal ZCB00 and AcrySof IQ SN6AWF MTF data - Abbott Medical Optics Inc., 8 May DOF2015CT0016. pg 28

29 WITH ENHANCED FUNCTIONALITY? LEAVE A LASTING LEGACY WITH IOLs THAT DELIVER SUSTAINABILITY pg 29

30 WITH ENHANCED FUNCTIONALITY? IOL MATERIAL is not associated with glistenings 1 VS AcrySof IOLs have glistenings X 40X GLISTENINGS CAUSE LIGHT SCATTER which can result in reduction in image contrast 6-8 DARK FIELD IMAGES OF AcrySof LENS 9 1. Data on File 150 Sensar not associated with glistenings Literature analysis. Abbott Medical Optics Inc., REF2014OTH Christiansen G, et al. Glistenings in the AcrySof intraocular lens: Pilot study. JCRS 2001;27: REF2014MLT Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. JCRS 2012; 38: REF2014MLT Gunenc U, et al M. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. JCRS 2001; 27: REF2014MLT Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS 2010; 36: REF2015CT Bousquet M, PhD, Health Canada. Intraocular lenses and the development of glistenings. Health Canada Adverse Reaction Newsletter REF2015CT Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. JCRS 2004; 30: REF2014OTH van der Mooren M, et al. Explanted multifocal intraocular lenses. JCRS 2015; 41: REF2015OTH van der Mooren M, et al. Effects of glistenings in intraocular lenses. Biomedical Optics Express. 11 July 2013: REF2014OTH0139. pg 30

31 WITH WHAT WILL YOUR LEGACY BE? Your patients vision is only as good as the IOL you leave behind. Don t wait to leave a legacy of excellent outcomes with peace of mind. Start now with the Monofocal 1-Piece IOL and TECNIS itec Preloaded Delivery System. pg 31

32 WITH TECHNICAL SPECIFICATIONS TECNIS itec Preloaded Delivery System (PCB00) Incision Size: Delivery System: Injector Type: 2.2 mm 2.4 mm Screw-style Disposable Monofocal 1-Piece IOL OPTIC CHARACTERISTICS Power Range: Diameter: Shape: Material: Refractive Index: Edge Design: BIOMETRY A-constant: HAPTIC CHARACTERISTICS Overall Length: Style: Material: Design: +5.0 D to D in 0.5 diopter increments 6.0 mm Biconvex, anterior aspheric surface, square optic edge UV-blocking hydrophobic acrylic 1.47 at 35 C ProTEC frosted, continuous 360 posterior square edge (Optical Biometry)* (Ultrasound Biometry-Contact) 13.0 mm C UV-blocking hydrophobic acrylic Haptics offset from optic *Derived from clinical evaluation results of the 1-Piece IOL platform. Value theoretically derived for a typical 20.0 D lens. Abbott Medical Optics recommends that surgeons personalise their A-constant based on their surgical techniques and equipment, experience with the lens model, and postoperative results. pg 32

33 WITH INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM AND FOR 1-PIECE Rx Only ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. INDICATIONS: The 1-Piece lens is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. PRECAUTIONS: Do not resterilise the lens. Most sterilisers are not equipped to sterilise the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113 F (45 C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the 1-Piece lens may become damaged. WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The 1-Piece IOL should not be placed in the ciliary sulcus. ADVERSE EVENTS: In 3.3% of patients, reported adverse events of cataract surgery with the 1- Piece IOL included macular oedema. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic). TECNIS, TECNIS itec, and ProTEC are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. AcrySof is a trademark of Novartis AG Corp Abbott Medical Optics Inc. PP2017CT0544 For healthcare professionals only. pg 33