choose outstanding vision +3.25 +2.75 for whatever life’s ... · +3.25 +2.75 +4.0 +3.25 +2.75...

+3.25

+2.75

+4.0 +3.25

+2.75

+4.0 +3.25

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Choose outstanding Visionfor whatever life’s focus.

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Important IndIcatIons and safety InformatIon for the tecnIs® multIfocal famIly of IolscautIon: Federal law restricts this device to sale by or on the order of a physician. IndIcatIons: The TECNIS® Multifocal 1-Piece 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. See Important Safety Information on page 8.

42 cmTheoretical Reading Distance

33 cmTheoretical Reading Distance

Theoretical Reading Distance

50 cm

a full range of outstanding Vision;personalized to eaCh patient’s lifestyle Introducing the New TeCNIS® MulTIfoCal faMIly of Iols

Backed by proven IOL technology, the TECNIS® Multifocal Family of 1-Piece IOLs now includes three distinct lenses, each delivering outstanding vision across all distances with enhanced performance at distances tailored to each individual patient’s lifestyle.

• High patient satisfaction

• Personalized solutions for your patients

• High spectacle independence

• High performance* in any lighting conditions1

• Full diffractive surface for pupil independence

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+4.0

+2.75

* Binocular best corrected distance contrast sensitivity

Personalized Performance With new +2.75 D and +3.25 D lenses, the TECNIS® Multifocal Family of 1-Piece IOLs gives you the option to choose the lens distinctly suited to your patients’ lifestyles. Each lens provides a full range of outstanding vision, optimized for intermediate vision, longer reading distance or near vision activities.

Outstanding VisiOn The TECNIS® Multifocal Family of 1-Piece IOLs incorporates a full diffractive optic pattern designed to provide near, intermediate and distance vision with increased spectacle independence. Each lens delivers high visual performance in any lighting conditions* as well as high levels of patient satisfaction.

Superior DeSign From their unique design to proprietary manufacturing process, TECNIS® Multifocal Family of 1-Piece IOLs are engineered for high-quality vision. Each lens is made using an acrylic lens material and wavefront aspheric optics designed to reduce chromatic aberration2 and correct spherical aberration to essentially zero.3

“ For peers who aren’t currently on the TECNIS® Multifocal platform, I would say this is the time to switch over.” —Daniel Chang, MD, Bakersfield, California

WARNINGS: 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. 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. See Important Safety Information continued on page 8.

3TECNIS® MulTIfoCal faMIly of 1-PIECE Iols

The quality you expect the options your patients deserVethe neW teCnis® MultifoCal faMily of 1-pieCe iols allows you to provide a full range of outstanding vision with enhanced performance at one of three optimized reading distances. Whichever option you choose, TECNIS® IOL technology delivers high degrees of spectacle independence and patient satisfaction.

“ With all three lens powers, now we are going to have a level of customization for each specific patient that we have not had before.”

— Jeffrey Whitsett, MD, Houston, Texas

ability to funCtion CoMfortably without Glasses at All Distances (6 Months)1*

ZM900 (+4.0 D) data are historical from a separate clinical study using the same test methodology.

disCoVer the neW +2.75 d and +3.25 d teCnis® MultifoCal 1-pieCe iols

would elect to have the same IOL again*

94%

mean binocular VA near uncorrected*

20/25

mean binocular VA distance uncorrected*

20/200

40

80

20

60

100

10

50

90

30

70

% O

F PA

TIEN

TS

+2.75 D (ZKB00) +3.25 D (ZLB00) +4.0 D (ZM900)

81%

98% 98%

86%

98% 96%94%

85%90%

NEAR INTERMEDIATE DISTANCE

4 TECNIS® MulTIfoCal faMIly of 1-PIECE Iols

*CLINICAL STUDY DeSIgN for The TeCNIS® MULTIfoCAL 1-PIeCe IoL, MoDeLS ZKB00 (+2.75 D) AND ZLB00 (+3.25 D): Clinical data presented are 6-month postoperative results from an IDE prospective, multicenter, bilateral, open-label, evaluator-masked, modified-parallel group trial. A total of 445 subjects were enrolled and implanted (441 bilaterally implanted). Of these, 147 were in the ZKB00 IOL group, 150 were in the ZLB00 group and 148 were in the monofocal control group. CLINICAL STUDY DeSIgN for The TeCNIS®

MULTIfoCAL LeNS, MoDeL ZM900: Two clinical studies were conducted with the silicone version, Model ZM900. The initial clinical study was a one-year, multicenter, evaluator-masked, bilateral, parallel-group comparative clinical evaluation; the second study was a one-year, multicenter, open-label, unilateral or bilateral, expansion study. Across both studies, 347 total ZM900 subjects (306 bilaterally implanted) and 123 monofocal control subjects (122 bilaterally implanted) were enrolled. In the initial study, subjects’ lens group assignment was not randomized; each subject was implanted with either ZM900 lenses or monofocal control lenses according to the subject’s preference. The 4-6 month study results are presented for 335 TECNIS® multifocal subjects (297 bilaterally implanted) and 119 bilaterally implanted monofocal subjects. A subjective questionnaire with sponsor-developed questions, regarding visual quality, subject satisfaction, and spectacle usage was administered for the ZKB00, ZLB00 and ZM900 by third-party, masked interviewers following the clinical study exams at 6 months. The questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence.

96% 86% 42 cm

NEW teCnis® MultifoCal iol +3.25*, 1 Optimized for patients favoring activities at longer reading distances such as multimedia work.


% bilateral patients with ability to function comfortably without glasses at all distances

% bilateral patients with ability to function comfortably without glasses at intermediate and far distances

84%% bilateral patients reported no difficulty (with glasses if needed) with night vision at 6 months

94% 85% 33 cm

teCnis® MultifoCal iol +4.0*, 1

Optimized for patients favoring near-vision activities such as reading and knitting.



% patients with binocular simultaneous 20/25 or better distance and 20/32 or better near with distance correction only

87%% bilateral patients would elect to have the same IOL again

98% 91% 81% 50 cm

NEW teCnis® MultifoCal iol +2.75*, 1 Optimized for patients favoring intermediate-vision activities such as golfing and grocery shopping.



% bilateral patients with ability to function comfortably without glasses at intermediate and far distances

% bilateral patients reported no difficulty (with glasses if needed) with night vision at 6 months


Designed for high perforManCe

Adjusted Binocular Defocus Curve at 6 Months (Bilateral Subjects)4

personalized outCoMesThe TECNIS® Multifocal Family of IOLs delivers a full range of outstanding vision with enhanced performance at one of three focal points, giving you the ability to personalize your patients’ near-to-intermediate distance vision.

ZM900 (+4.0 D) data are historical from a separate clinical study using the same test methodology.

Non-directed responses from open-ended questions. First eye results only.

+2.75 d (ZKB00) +3.25 d (ZLB00) +4.0 d (ZM900)

spontaneous reports of night glare in a Non-Directed Study

spontaneous reports of halos in a Non-Directed StudySpontaneous Reports of Halos in a Non-Directed Study

HALOS REPORTED:

HALOS REPORTED:

SevereModerate MildNone

Severe

Moderate

Mild

None

% O

F SU

BJEC

TS

IOL MODEL

TECNIS® 1-Piece Aspheric IOL (ZCB00)

20

40

80

60

100

0

95.9%

0%1.4%2.7%

+2.75 D(ZKB00)

80%

0.7%5.5%

13.8%

+3.25 D(ZLB00)

75.4%

4%7.3%13.3%

Spontaneous Reports of Night Glare in a Non-Directed Study

NIGHT GLARE REPORTED:

NIGHT GLAREREPORTED:

SevereModerate MildNone

Severe

Moderate

Mild

None%

OF

SUBJ

ECTS

IOL MODEL

TECNIS® 1-Piece Aspheric IOL (ZCB00)

20

40

80

60

100

0

98.6%

0%0.7%0.7%

+2.75 D(ZKB00)

95.2%

0%1.4%3.4%

+3.25 D(ZLB00)

94.7%

2%2%1.3%

-2.00.0 -3.0-1.0 -4.0-2.5-0.5 -3.5-1.5 -4.5 -5.0

20/125 (0.8)

20/100 (0.7)

20/80 (0.6)

20/63 (0.5)

20/50 (0.4)

20/40 (0.3)

20/32 (0.2)

20/16 (-0.1)

20/12 (-0.2)

20/10 (-0.3)

20/25 (0.1)

20/20 (0)

Diopters of Defocus->snel

len

(lo

gM

ar) -

>

42 cm+3.25

50 cm+2.75

33 cm+4.0

6 TECNIS® MulTIfoCal faMIly of 1-PIECE Iols

high perforManCe in any lighting Conditions*A full diffractive surface for pupil independence.

Quality iol designThe TECNIS® IOL manufacturing method includes our proprietary single-point diamond cryolathing process, in which each lens is individually crafted and inspected to ensure consistency and quality.

near-zero spheriCal aberrationA wavefront-designed aspheric surface corrects spherical aberration to essentially zero.3

not assoCiated With glistenings5

The lens material is not associated with glistenings.

360˚ sQuare edgeThe edge of the optic has a frosted design to reduce potential edge glare effects.7

reduCed ChroMatiC aberrationThe quality lens material, with a refractive index of 1.47, helps reduce chromatic aberration for improved optical quality.2

healthy blue lightUV-only blocking allows the full transmission of healthy blue light.6

proVen teCnis® MultifoCal iol teChnology

to disCoVer More about how the TECNIS® Multifocal Family of IOLs can provide outstanding vision that suits your patients’ lifestyles, contact your local Abbott representative.

* Binocular best corrected distance contrast sensitivity


IMPORTANT SAFETY INFORMATION FOR ThE TECNIS® MulTIFOCAl FAMIlY OF 1-PIECE IOls (CONTINuEd)CAuTION: Federal law restricts this device to sale by or on the order of a physician. ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. WARNINGS: Physicians considering lens implantation under any of the conditions described in the Directions for Use should weigh the potential risk/benefit ratio prior to implanting a lens. 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. Care should be taken to achieve centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. Patients with certain medical conditions may not be suitable candidates for IOLs. Consult the Directions for Use for more information. PRECAuTIONS: Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. There were no patients 21 years old or younger included in the clinical studies; therefore there are insufficient clinical data to demonstrate safety and effectiveness in this age group. The central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils (~1mm) 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 (113˚F). Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. 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 IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. AdVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trials of the TECNIS® Multifocal lenses was surgical re-intervention, most of which were non-lens-related. Lens-related re-interventions occurred at a rate of 0.6% to 1.0%. Other surgical re-interventions included lens exchanges (for incorrect IOL power), retinal repair, ruptured globe repair, macular hole repair, removal of retained lens material, treatment injections for cystoid macular edema and iritis, and blepharoplasty.

IMPORTANT INdICATIONS ANd SAFETY INFORMATION FOR ThE TECNIS® 1-PIECE IOl (MONOFOCAl)CAuTION: Federal law restricts this device to sale by or on the order of a physician. ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. INdICATIONS: The TECNIS® 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. WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus. PRECAuTIONS: Do not reuse, resterilize, or autoclave. AdVERSE EVENTS: In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. 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).

1. DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00. 2. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9):1225–1229. 3. TECNIS Foldable Posterior Chamber Intraocular Lenses [package insert]. Abbott Medical Optics Inc. 4. Data on file. Abbott Medical Optics Inc. Santa Ana, California. 5. Data on file. Abbott Medical Optics Inc. 2013. 6. Mainster MA. Violet and blue-light blocking intraocular lenses: photoprotection versus photoreception. Br J Ophthalmol. 2006;90:784-792. 7. Nixon DR. New technologies for premium outcomes: next generation phaco and TECNIS 1-Piece IOL. Presented at 25th Congress of ESCRS 2007, Stockholhm, Sweden. 8. Calculated based on Holladay I formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24).TECNIS and ProTEC are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. © 2015 Abbott Medical Optics, Inc. | www.AbbottMedicalOptics.com | PP2015MLT0004 | TEC15-04

† Value theoretically derived for a typical 20.0 D lens. AMO recommends that surgeons personalize their A-constant based on their surgical techniques and equipment, experience with the lens model and postoperative results.

†† Derived from clinical evaluation results of the TECNIS® 1-Piece platform.

+3.25

+2.75

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+2.75

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+2.75

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NEW

NEWoptiC CharaCteristiCsPowers: +5.0 D to 34.0 D in 0.5 diopter incrementsDiameter: 6.0 mmShape: Biconvex, anterior aspheric surface, posterior diffractive surfaceAdd Power (IOL Plane): +2.75 d (ZKB00) +3.25 d (ZLB00) +4.0 d (ZMB00)Add Power (Spec Plane): +2.01 d (ZKB00) +2.37 d (ZLB00) +3.0 d (ZMB00)Material: UV-blocking hydrophobic acrylicRefractive Index: 1.47Spherical Aberration: -0.27Chromatic Aberration (Abbe Number): 55Edge Design: proteC frosted, continuous 360° posterior square edgebioMetry† ContaCt ultrasound optiCalA-Constant: 118.8† 119.3††Theoretical AC Depth: 5.40 mm 5.72 mmSurgeon Factor:8 1.68 mm 1.96 mmhaptiC CharaCteristiCsOverall Length: 13.0 mmStyle: CMaterial: UV-blocking hydrophobic acrylicDesign: Haptics offset from optic

choose outstanding vision +3.25 +2.75 for whatever life’s ... · +3.25 +2.75 +4.0 +3.25 +2.75...

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