Visit Abbott Medical Optics
This site is intended for customers outside the United States. | Switch to: United States
Return Home
Indications and Important Safety Information
Visit Abbott Medical Optics
nav_patient nav_physician
TECNIS Symfony

TECNIS® TECNIS Symfony Logo IOL

The latest addition to the TECNIS® Family of IOLs offers new optical technology for providing an Extended Range of Vision.

Traditional IOL solutions for treating presbyopia include Multifocals and Trifocals, which work on the principle of simultaneous vision by splitting light into multiple distinct foci, and Accommodative IOLs, which change in shape and power when the ciliary muscle contracts.

Traditionally with these technologies, the correction of presbyopia is commonly thought of in terms of the distinct distance for which functional vision is provided.

Key Needs for Presbyopia-Correcting IOLs

  • High patient satisfaction by providing reliable outcomes
  • Low number of complaints (on refractive outcomes or halos and glare)
  • No significant additional chair time

Introducing TECNIS® Symfony Logo IOL, the first and only presbyopia-correcting extended range of vision IOL.

The TECNIS® Symfony Logo Extended Range of Vision IOL delivers a continuous, full range of high-quality vision with incidence of halos and glare comparable to a monofocal IOL.1, 2

Introduction Toric and Non-Toric

TECNIS® Symfony Logo Extended Range of Vision IOL is available in both a Non-Toric version and a Toric version for patients with astigmatism.

  1. 168 Data on File_Symfony_Simulated Defocus Curves
  2. 166 Data on File_Extended Range of Vision IOL 3-Month Study Results (NZ)

Mechanism of Action

TECNIS® Symfony Logo IOL merges two complementary enabling technologies

  1. The proprietary diffractive echelette design feature extends the range of vision.1
  2. The proprietary achromatic technology corrects chromatic aberration for enhanced contrast sensitivity.2

Proprietary Diffractive Echelette Design Feature Extends The Range Of Vision

Proprietary diffractive echelette design feature introduces a novel pattern of light diffraction that elongates the focus of the eye resulting in an extended range of vision.1

Proprietary Diffractive Echelette Design Feature

As evidenced by the measured light pattern when projected through the TECNIS® monofocal IOL, TECNIS® multifocal IOL and the TECNIS® Symfony extended range of vision IOL, there is one distinct focal point for distance with the TECNIS® monofocal lens, two distinct foci for the TECNIS® multifocal lens, and one elongated focal point for the TECNIS® Symfony extended range of vision IOL.


Elongated Focus Leads to the Continuous Range of High-Quality Vision1

The novel pattern of light diffraction projected through the TECNIS® Symfony IOL is shown below, along with the light patterns projected through the TECNIS® monofocal and TECNIS® multifocal IOLs for comparison.

The elongated focus of the TECNIS® Symfony lens leads to:

  • A continuous range of high-quality vision for far, intermediate, and near distances1
  • Halo and glare comparable to a monofocal (distinct single focus) IOL3
    • Multifocal IOLs work on the principle of simultaneous vision; one image is in focus while the out-of-focus image is suppressed; halos are caused by the out-of-focus image. Because the TECNIS® Symfony IOL has one elongated focus it has the halo and glare profile comparable to a monofocal IOL.3


TECNIS® Monofocal IOL Focus Demo 1
TECNIS® Multifocal IOL Focus Demo 2
TECNIS® Symfony IOL Focus Demo 3

Clinically Significant Increase In Range Of Vision

TECNIS® Symfony Logo IOL Showed:3

  • 20/20 or better mean visual acuity from distance to 1.5 D of defocus
  • 20/40 or better mean visual acuity from distance to 2.5 D of defocus
  • 1.0 D increase in depth of focus throughout the defocus curve
Defocus Curve

Proprietary Achromatic Technology Corrects Chromatic Aberration2

Chromatic Aberration = 1.2 D Chromatic Aberration = 0.14 D
Chromatic Aberration = 1.2 D4 Chromatic Aberration = 0.14 D5
  • The refractive index of the eye varies with wavelength causing the power of the eye to be wavelength dependent. Colors that are out-of-focus cause blur and reductions in contrast vision. This is called chromatic aberration.
  • The average eye has approximately 2 D of chromatic aberration between 400 and 700nm and 0.8 D between 500 and 640nm.6
  • Chromatic aberration can be corrected with a diffractive IOL with achromatic technology.4

Proprietary Achromatic Technology Results In Contrast Enhancement

Achromat technology for the correction of longitudinal chromatic aberration (LCA) causes contrast enhancement.

Correction of corneal chromatic aberration results in a sharper focus of light. When combined with correction of spherical aberration, it increases retinal image quality, without negatively affecting depth of focus.5,7

LCA = 1.20 Diopters4 LCA = 0.14 Diopters5
Photopic pupil
Mesopic pupil

Proprietary Achromatic Technology Results In Contrast Enhancement

Modulation transfer function (MTF) calculated for mesopic pupil sizes in clinically-validated eye models.5

  • MTF is a measure of the amount of contrast transferred by the optics in a visual system.5
  • The higher the MTF value, the more contrast is transferred to the image resulting in higher contrast sensitivity.5
Diopters of Focus

CONTRAST PERFORMANCE OF TECNIS® Symfony Logo EQUIVALENT TO TECNIS® 1PC MONOFOCAL IOL

White light MTF at 50 c/mm measured in the ACE model eye for a 5 mm pupil.8

Contrast Performance
  1. TECNIS Symfony DFU, Z310939 Rev. 03 Revision Date: 10-03-2014
  2. 175 Data on File_Correction of chromatic aberration of the TECNIS Symfony IOL
  3. 166 Data on File_Extended Range of Vision IOL 3-Month Study Results (NZ)
  4. Chromatic aberration between 500nm and 640nm, Nagata et al, 1999
  5. Weeber, H.A., & Piers, P.A. (2012). Theoretical Performance of Intraocular Lenses correcting both Spherical and Chromatic Aberration. J Refr Surg, 28 (1), 48-52.
  6. Thibos, et al. The chromatic eye: a new reduced-eye model of ocular chromatic aberration in humans. Applied Optics, Vol. 31, Issue 19, pp. 3594-3600 (1992)
  7. Artal, P., Manzanera, S., Piers, P., & Weeber, H. (2010). Visual effect of the combined correction of spherical and longitudinal chromatic aberrations. Opt Express, 18 (2), 1637-1648.
  8. 170 Data on File_Symfony_Modulation Transfer Function

New Zealand Clinical Study Confirmed Benefits of TECNIS® Symfony Logo IOL

Objective

  • To confirm clinical benefits of TECNIS® Symfony Logo Extended Range of Vision IOL when implanted bilaterally

Design

  • Open-label, multicenter study with up to three months follow-up

Treatments

  • 31 subjects bilaterally implanted with TECNIS® Symfony LogoIOL and 10 subjects bilaterally implanted with TECNIS® Monofocal 1-Piece ZCB00 IOL

Endpoints

  • Defocus testing
  • Visual acuity
  • Dysphotopsia
  • Spectacle independence
  • Patient satisfaction

Status

  • All 3-month visits completed

Clinically Significant Increase in Range of Vision

TECNIS® Symfony Logo IOL Showed:1

  • 20/20 or better mean visual acuity from distance to 1.5 D of defocus
  • 20/40 or better mean visual acuity from distance to 2.5 D of defocus
  • 1.0 D increase in depth of focus throughout the defocus curve
Defocus Curve

Near and Intermediate Visual Acuity Improvement Over Monofocal IOL

TECNIS® Symfony Logo IOL Showed:1

  • 20/20 or better mean distance and intermediate visual acuity
  • A 2-line improvement in mean intermediate and near visual acuity
Mean Visual Acuity

Better Functional Vision Than a Monofocal IOL

TECNIS® Symfony Logo IOL patients experienced decreased limitations in performing near and intermediate tasks vs. monofocal.1

Clinical Limitation without Glasses

High Spectacle Independence with Halos Comparable to a monofocal IOL

High Spectacle Independence1

  • At three months, almost all TECNIS® Symfony Logo IOL subjects experienced high spectacle independence at far, intermediate, and near distances.

Halos Comparable to a Monofocal IOL1

  • TECNIS® Symfony Logo subjects reported no significant difference in glare or halo occurrence compared to a monofocal IOL.
  • There were no spontaneous reports of glare or halo at 3-month postop follow-up visit.
Clinical Percentage Never Wearing Glasses

High Patient Satisfaction

97% of the 31 subjects implanted with the TECNIS® Symfony Logo IOL indicated that they would elect to have the lens implanted again.1

Clinical High Satisfaction

New Zealand Study Micro-monovision Evaluation

Objective

  • To evaluate the effects of micro-monovision on visual performance with the TECNIS® Symfony Logo IOL

Design

  • Open-label, multicenter study with at least six months follow-up

Treatments

  • Up to 31 subjects bilaterally implanted with TECNIS® Symfony Logo IOL

Methods

  • Binocular visual acuities were measured at far, intermediate, and near through a series of simulated micro-monovision correction (+0.50, +0.75 or +1.00D unilaterally added over the manifest refraction)

Status

  • 26 subjects have completed 6-12 month postoperative follow-up

Binocular Visual Acuities

IOL Mean Visual Acuities Visual Acuities Table 1

Binocular Visual Acuities

IOL Mean Visual Acuities Visual Acuities Table 2

Binocular Visual Acuities

IOL Mean Visual Acuities Visual Acuities Table 3

Binocular Visual Acuities

IOL Mean Visual Acuities Visual Acuities Table 4
  1. 166 Data on File_Extended Range of Vision IOL 3-Month Study Results (NZ)
  2. 174 Data on File_”Encore” Study (ERIL-105-XA03 Extension) Clinical investigation of IOL model XRA03.

TECNIS® Symfony Logo Extended Range of Vision IOL Product Profile

Optical Characteristics
Powers: +5.0 D to +34.0 D in 0.5 diopter increments
Diameter: 6.0 mm
Center Thickness: 0.7 mm (20.0 D)
Shape: Biconvex, wavefront-designed anterior aspheric surface, posterior achromatic diffractive surface to correct chromatic aberration for enhanced contrast sensitivity and echelette feature to extend the range of vision.1,2
Material: UV-blocking hydrophobic acrylic
Refractive Index: 1.47 at 35° C
Edge Design: ProTEC frosted, continuous 360° posterior square edge
Biometry* Contact Ultrasound Optical
A-constant: 118.8 119.3
Theoretical AC Depth: 5.4 mm 5.7 mm
Surgeon Factor:3 1.68 mm 1.96 mm
Haptic Characteristics
Overall Diameter: 13.0 mm
Thickness: 0.46 mm
Style: C
Material: Soft, Foldable, UV-blocking hydrophobic acrylic
Design: TRI-FIX haptics offset from optic; 1-piece lens
Recommended Insertion Instruments
UNFOLDER Platinum 1 Series Screw-Style Inserter (DK7796) UNFOLDER Platinum 1 Series Cartridge (1MTEC30)
UNFOLDER Emerald-AR Inserter (EMERALDAR) UNFOLDER Emerald-AR Cartridge (1CART30)
UNFOLDER Ultra Syringe-Style Inserter (DK7786) UNFOLDER Ultra Cartridge (1VIPR30)
*Value theoretically derived for a typical 22.0 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.

TECNIS® Symfony Logo Toric Extended Range of Vision IOL Product Profile

Optical Characteristics
SE Powers: +5.0 D to +34.0 D in 0.5 diopter increments
Model Numbers: ZXT100 ZXT150 ZXT225 ZXT300 ZXT375 ZXT450 ZXT525 ZXT600
Cylinder Powers - IOL Plane: 1.00 D 1.50 D 2.25 D 3.00 D 3.75 D 4.50 D 5.25 D 6.00 D
Cylinder Powers - Corneal Plane: 0.69 D 1.03 D 1.54 D 2.06 D 2.57 D 3.08 D 3.60 D 4.11 D
Diameter: 6.0 mm
Center Thickness: 0.7 mm (20.0 D)
Shape: Biconvex, wavefront-designed anterior aspheric surface, posterior achromatic diffractive surface to correct chromatic aberration for enhanced contrast sensitivity and echelette feature to extend the range of vision.1,2
Material: UV-blocking hydrophobic acrylic
Refractive Index: 1.47 at 35° C
Edge Design: ProTEC frosted, continuous 360° posterior square edge
Biometry* Contact Ultrasound Optical
A-constant: 118.8 119.3
Theoretical AC Depth: 5.4 mm 5.7 mm
Surgeon Factor:3 1.68 mm 1.96 mm
Haptic Characteristics
Overall Diameter: 13.0 mm
Thickness: 0.46 mm
Style: C
Material: Soft, Foldable, UV-blocking hydrophobic acrylic
Design: TRI-FIX haptics offset from optic; 1-piece lens
Recommended Insertion Instruments
UNFOLDER Platinum 1 Series Screw-Style Inserter (DK7796) UNFOLDER Platinum 1 Series Cartridge (1MTEC30)
UNFOLDER Emerald-AR Inserter (EMERALDAR) UNFOLDER Emerald-AR Cartridge (1CART30)
UNFOLDER Ultra Syringe-Style Inserter (DK7786) UNFOLDER Ultra Cartridge (1VIPR30)
*Value theoretically derived for a typical 22.0 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.

Getting started with TECNIS® Symfony Logo IOL and TECNIS® Symfony Logo Toric IOL.

TECNIS® Symfony IOL and TECNIS® Symfony Toric IOL

  • Max plus refraction
    • Postoperatively, TECNIS® Symfony IOL patient's eyes should be refracted to the maximum plus or (least minus) through which the best distance visual acuity is achieved. This ensures that distance visual acuity remains optimal while providing the greatest extent of focus at intermediate and near.
  • Use personalized or optimized IOL constants. Refer to ULIB database for optimized IOL constants

TECNIS® Symfony Toric IOL (only)

  • Perform comprehensive diagnosis of the astigmatic eye
    • Preoperative measurements, Biometery, Keratomery, Topography
  • Prepare accurate alignment of the TECNIS® Symfony Toric IOL
    • Preoperative marking
    • Intraoperative marking
  • With the TECNIS® Symfony Toric IOL, the flat meridian is marked with dots; these dots need to be aligned with the steep meridian of the cornea
  • Place lens 5-10 degrees counterclockwise of final position; dial to final position after OVD removal
  • To minimize rotation:
    • First, hydrate the incision, then remove OVD
    • Carefully remove OVD behind the lens
    • Push IOL gently against the posterior capsule when in the final position
    • Use cohesive OVDs
    • Do not over-pressurize the eye

Directions for Use (PDF-4.8MB) TECNIS® IOL Calculator
  1. TECNIS Symfony DFU, Z310939 Rev. 03 Revision Date: 10-03-2014
  2. 175 Data on File_Correction of chromatic aberration of the TECNIS Symfony IOL
  3. 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).
Caution:

Do not use the lens if the package has been damaged. The sterility of the lens may have been compromised.

Indications for use:

The TECNIS® Symfony IOL, Model ZXR00, is 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 extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. This device is intended to be placed in the capsular bag. The TECNIS® Symfony IOLs, Models ZXT100, ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and preexisting corneal astigmatism in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, a reduction of residual refractive cylinder, and increased spectacle independence. These devices are intended to be placed in the capsular bag.

Precautions:
  1. Automated examinations may not give reliable results. These may include: autorefractors using infrared light, wavefront sensors, infrared photorefractors, and the Duochrome test. Manifest refraction with maximum plus technique is recommended.
  2. The ability to perform some eye treatments (eg.retinal photocoagulation) and/or examinations (eg.autorefraction) may be affected by the TECNIS® Symfony IOL optical design.
  3. Recent contact lens usage may affect the patient's refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.
  4. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects.
  5. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline.
  6. Do not store the lens in direct sunlight or at a temperature greater than 113 °F (45 °CDo not autoclave the intraocular lens.
  7. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date.
  8. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.
  9. Care should be taken to achieve centration of the intraocular lens.
  10. 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.
  11. When the insertion system is used improperly, the haptics of the TECNIS® Symfony IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system.
Warnings:

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

  1. Mild visual effects associated with a TECNIS® Symfony IOL may occur because of the superposition of focused and unfocused images. These may include a perception of halos or glare around lights under nighttime conditions. Preclinical evaluation indicated that these phenomena are comparable to those of a standard monofocal lens.
  2. Low-contrast image quality may be reduced compared to a monofocal lens. However, preclinical and clinical data indicate that the reduction of image contrast is none to minimal.
  3. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient's eyesight:
    1. Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye.
    2. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases.
    3. 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).
    4. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible.
    5. Circumstances that would result in damage to the endothelium during implantation.
    6. Suspected microbial infection.
    7. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL.
    8. Congenital bilateral cataracts
    9. Previous history of, or a predisposition to, retinal detachment.
    10. Patients with only one good eye with potentially good vision.
    11. Medically uncontrollable glaucoma.
    12. Corneal endothelial dystrophy.
    13. Proliferative diabetic retinopathy.
    14. Children under the age of 2 years are not suitable candidates for intraocular lenses.
  4. The TECNIS® Symfony IOLs should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.
  5. Patients should be informed about the possibility of a decrease in contrast sensitivity or an increase in visual disturbances compared to a monofocal IOL.
  6. The TECNIS® Symfony IOL, Model ZXR00, has not been evaluated for patients with a predicted postoperative astigmatism greater than 1.0 diopter.
  7. Rotation of toric TECNIS® Symfony IOLs away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
  8. Carefully remove all viscoelastic from the capsular bag. Residual viscoelastic may allow the lens to rotate, causing misalignment of the toric TECNIS® Symfony IOL with the intended axis of placement.
  9. AMO IOLs are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The resterilization/reprocessing of AMO IOLs may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.
Adverse Events:

General Adverse Events for IOLs

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to:

  1. Endophthalmitis/intraocular infection
  2. Hypopyon
  3. IOL dislocation
  4. Pupillary block
  5. Retinal detachment
  6. Persistent corneal stromal edema
  7. Persistent cystoid macular edema
  8. Secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure)
  9. Any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment
Attention:

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another.

Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of the company.
©2014 Abbott Laboratories Inc. Abbott Park, Illinois, USA
www.AbbottMedicalOptics.com
PP2014CT0306

LegalPrivacy PolicyTerms of Use
Visit Abbott Medical Optics Return Home Visit Abbott Medical Optics Visit Abbott Medical Optics Visit Abbott Medical Optics