NEW FROM - Abbott Medical Optics

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NEW FROM
THE TECNIS ®
MULTIFOCAL
FAMILY OF IOLs:
TECNIS® Multifocal
1-Piece Aspheric IOL
Hydrophobic Acrylic
+2.75 D Add Power+4.0
13.0 MM
OVERALL DIAMETER
TECNIS® IOL
WAVEFRONT-DESIGNED
ASPHERIC SURFACE
FROSTED, CONTINUOUS
360° POSTERIOR
SQUARE EDGE
The TECNIS® Multifocal IOL +2.75 D add
power delivers a full range of outstanding
vision with enhanced performance at a
theoretical reading distance of 50 cm.
+3.25
POSTERIOR
DIFFRACTIVE
SURFACE
(15 diffractive rings)
+2.75
6.0 MM
OPTIC DIAMETER
NEW
ANTERIOR SIDE
POSTERIOR SIDE
HAPTICS OFFSET FOR
3 POINTS OF FIXATION
+2.75
NEW
MODEL: ZKB00
OPTIC CHARACTERISTICS
Powers:
Diameter:
Shape:
Add Power (IOL Plane):
Add Power (Spec Plane):
Material:
Refractive Index:
Chromatic Aberration (Abbe Number):
Edge Design:
+5.0 D to 34.0 D in 0.5 diopter increments
6.0 mm
Biconvex, anterior aspheric surface, posterior diffractive surface
+2.75 D
+2.01 D
UV-blocking hydrophobic acrylic
1.47
55
ProTEC frosted, continuous 360° posterior square edge
BIOMETRY
CONTACT ULTRASOUND OPTICAL
A-Constant:
Theoretical AC Depth:
Surgeon Factor:1
118.8*119.3†
5.40 mm5.72 mm
1.68 mm1.96 mm
HAPTIC CHARACTERISTICS
Overall Length:
Style:
Material:
Design:
13.0 mm
C
UV-blocking hydrophobic acrylic
Haptics offset from optic
RECOMMENDED INSERTION INSTRUMENTS
MODEL
UNFOLDER® Platinum 1 Series
Screw-Style Inserter
DK7796
UNFOLDER® Platinum 1 Series Cartridge
1MTEC30
*Value theoretically derived for a typical 20.00 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.
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.
IMPORTANT INDICATIONS AND SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL 1-PIECE IOLs, MODELS ZKB00 AND ZLB00
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® Multifocal 1-Piece intraocular lenses, Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D), 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 should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications
or impact patient outcomes. 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. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual
disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.
PRECAUTIONS: Prior to surgery, 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. The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with
controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave.
ADVERSE EVENTS: Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically
higher than the FDA grid rate (for both first and second eyes).
1. Calculated based on Holladay I formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruis RS. A three-part system for refining intraocular
lens power calculations. J Cataract Refract Surg. 1988;14(1)17-24).
TECNIS, ProTEC and UNFOLDER are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
©2015 Abbott Medical Optics Inc. www.AbbottMedicalOptics.com | PP2015CT0181 | TEC15-02
NEW FROM
THE TECNIS ®
MULTIFOCAL
FAMILY OF IOLs:
TECNIS® Multifocal
1-Piece Aspheric IOL
Hydrophobic Acrylic
+3.25 D Add Power
13.0 MM
OVERALL DIAMETER
TECNIS® IOL
WAVEFRONT-DESIGNED
ASPHERIC SURFACE
FROSTED, CONTINUOUS
360° POSTERIOR
SQUARE EDGE
The TECNIS® Multifocal IOL +3.25 D add
power delivers a full range of outstanding
vision with enhanced performance at a
theoretical reading distance of 42 cm.
+4.0
POSTERIOR
DIFFRACTIVE
SURFACE
(18 diffractive rings)
+3.25
NEW
6.0 MM
OPTIC DIAMETER
+2.75
ANTERIOR SIDE
POSTERIOR SIDE
HAPTICS OFFSET FOR
3 POINTS OF FIXATION
+4.0
+3.25
NEW
MODEL: ZLB00
OPTIC CHARACTERISTICS
+2.75
Powers:
Diameter:
Shape:
Add Power (IOL Plane):
Add Power (Spec Plane):
Material:
Refractive Index:
Chromatic Aberration (Abbe Number):
Edge Design:
+5.0 D to 34.0 D in 0.5 diopter increments
6.0 mm
Biconvex, anterior aspheric surface, posterior diffractive surface
+3.25 D
+2.37 D
UV-blocking hydrophobic acrylic
1.47
55
ProTEC frosted, continuous 360° posterior square edge
BIOMETRY
CONTACT ULTRASOUND OPTICAL
A-Constant:
Theoretical AC Depth:
Surgeon Factor:1
118.8*119.3†
5.40 mm5.72 mm
1.68 mm1.96 mm
HAPTIC CHARACTERISTICS
Overall Length:
Style:
Material:
Design:
13.0 mm
C
UV-blocking hydrophobic acrylic
Haptics offset from optic
RECOMMENDED INSERTION INSTRUMENTS
MODEL
UNFOLDER Platinum 1 Series
Screw-Style Inserter
DK7796
UNFOLDER® Platinum 1 Series Cartridge
1MTEC30
®
*Value theoretically derived for a typical 20.00 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.
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.
IMPORTANT INDICATIONS AND SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL 1-PIECE IOLs, MODELS ZKB00 AND ZLB00
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® Multifocal 1-Piece intraocular lenses, Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D), 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 should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications
or impact patient outcomes. 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. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual
disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.
PRECAUTIONS: Prior to surgery, 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. The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with
controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave.
ADVERSE EVENTS: Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically
higher than the FDA grid rate (for both first and second eyes).
1. Calculated based on Holladay I formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruis RS. A three-part system for refining intraocular
lens power calculations. J Cataract Refract Surg. 1988;14(1)17-24).
TECNIS, ProTEC and UNFOLDER are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
©2015 Abbott Medical Optics Inc. www.AbbottMedicalOptics.com | PP2015CT0180 | TEC15-03
FROM THE
TECNIS ®
MULTIFOCAL
FAMILY OF IOLs:
TECNIS® Multifocal
1-Piece Aspheric IOL
Hydrophobic Acrylic
+4.0 D Add Power
13.0 MM
OVERALL DIAMETER
TECNIS® IOL
WAVEFRONT-DESIGNED
ASPHERIC SURFACE
FROSTED, CONTINUOUS
360° POSTERIOR
SQUARE EDGE
The TECNIS® Multifocal IOL +4.0 D add
power delivers a full range of outstanding
vision with enhanced performance at a
theoretical reading distance of 33 cm.
POSTERIOR
DIFFRACTIVE
SURFACE
(22 diffractive rings)
+4.0
6.0 MM
OPTIC DIAMETER
+3.25
+2.75
ANTERIOR SIDE
POSTERIOR SIDE
HAPTICS OFFSET FOR
3 POINTS OF FIXATION
+4.0
MODEL: ZMB00
OPTIC CHARACTERISTICS
Powers:
+3.25
Diameter:
Shape:
Add Power (IOL Plane):
Add Power (Spec Plane):
+2.75
Material:
Refractive Index:
Chromatic Aberration (Abbe Number):
Edge Design:
+5.0 D to 34.0 D in 0.5 diopter increments
6.0 mm
Biconvex, anterior aspheric surface, posterior diffractive surface
+4.0 D
+3.0 D
UV-blocking hydrophobic acrylic
1.47
55
ProTEC frosted, continuous 360° posterior square edge
BIOMETRY
CONTACT ULTRASOUND OPTICAL
A-Constant:
Theoretical AC Depth:
Surgeon Factor:1
118.8*119.3†
5.40 mm5.72 mm
1.68 mm1.96 mm
HAPTIC CHARACTERISTICS
Overall Length:
Style:
Material:
Design:
13.0 mm
C
UV-blocking hydrophobic acrylic
Haptics offset from optic
RECOMMENDED INSERTION INSTRUMENTS
MODEL
UNFOLDER® Platinum 1 Series
Screw-Style Inserter
UNFOLDER® Platinum 1 Series Cartridge
DK7796
1MTEC30
*Value theoretically derived for a typical 20.00 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.
TO DISCOVER MORE about how the TECNIS® Multifocal 1-Piece IOL can provide
outstanding vision that suits your patients’ lifestyles, contact your local Abbott representative.
INDICATIONS AND IMPORTANT SAFETY INFORMATION – TECNIS® MULTIFOCAL 1-PIECE IOLs
Rx ONLY
ATTENTION: Reference the Directions for Use labeling for a complete listing of Important Indications, Warnings, Precautions, and Adverse Events.
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 should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® Multifocal
1-Piece Intraocular Lens (IOL) Directions for Use that could increase complications or impact patient outcomes. The TECNIS® Multifocal 1-Piece Intraocular
lens should not be placed in the ciliary sulcus. Patients should be informed about the possibility that a decrease in contrast sensitivity and an increase in visual
disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.
PRECAUTIONS: The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in
patients with controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave. 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 TECNIS® Multifocal 1-Piece lens may become broken. Please refer to the specific instructions for use provided with the
insertion instrument or system.
ADVERSE EVENTS: The most frequently reported cumulative adverse event for first eyes during the clinical trial was secondary surgical reintervention 3.7%
with 0.6% being lens-related. The total number of first eyes with lens-related events during and after the study was 0.9%. Other reported adverse events for
first eyes was endophthalmitis (0.3%).
1. Calculated based on Holladay I formula (Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruis RS. A three-part system for refining
intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1)17-24).
TECNIS, ProTEC and UNFOLDER are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
©2015 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2015CT0182 | TEC15-08
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