TECNIS®
MULTIFOCAL 1-Piece IOLs

FIND A LENS FOR EACH LIFE.

Personalize your approach to spectacle independence with tailored, full-range vision.

No two patients are exactly alike, especially when it comes to visual demand. With options to meet varying priorities, TECNIS® Multifocal 1-Piece IOLs empower you to deliver increased spectacle independence and a full range of outstanding vision with enhanced performance where each patient needs it most.

SHARPEST VISION ACROSS ALL DISTANCES

The TECNIS® Multifocal Family of 1-Piece IOLs features the only multifocal lenses capable of providing a full range of high-quality vision (20/25 or better)1,2 tailored for each patient’s lifestyle.

  • The sharpest vision across near, intermediate and distance vision1,2
  • Enhanced focus at one of three near distances

When compared to other leading multifocal IOLs, TECNIS® Multifocal 1-Piece IOLs provide:

  • Up to 4x higher image contrast at near distance in low light conditions (5 mm pupil)3
  • 2x higher image contrast at near distance in normal light conditions (3 mm pupil)3

ENHANCED FUNCTIONALITY

TECNIS® Multifocal 1-Piece IOLs deliver tailored spectacle independence and exceptional low-light performance for outstanding outcomes.

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

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

Give your patients outstanding low-light performance:

  • Up to 90.8% of patients experienced no difficulty with night vision**1
  • Up to 76.8% of patients experienced no difficulty with glare**1
  • Up to 69% of patients experienced no difficulty with halos**1

LONG-TERM SUSTAINABILITY

Unlike another leading IOL, TECNIS® IOL material is not associated with glistenings,4-8 which can inhibit your patients’ vision. Glistenings cause light scatter, which can result in a reduction in image contrast.5-9

Up to 97% of patients would elect to have a TECNIS® Multifocal 1-Piece IOL again.*1

EXCELLENT OUTCOMES FOR EACH PATIENT’S LIFESTYLE

With TECNIS® Multifocal IOLs, you can give each patient a full range of the sharpest vision with enhanced focus where they’ll use it most. Each lens is tailored for peak performance at one of three near distances.

Tecnis Multifocal 4.0D

Tecnis Multifocal 4.0D

Optimized for near vision
Vision Activities: Reading, fine detail work
Theoretical Reading Distance: 33 cm

+4.0 SPEC SHEET (PDF - 386KB)

Tecnis Multifocal 3.25D

Tecnis Multifocal 3.25D

Optimized for longer reading distances
Vision Activities: Multimedia work
Theoretical Reading Distance: 42 cm

+3.25 SPEC SHEET (PDF - 295KB)

Tecnis Multifocal 2.75D

Tecnis Multifocal 2.75D

Optimized for intermediate vision
Vision Activities: Golfing, grocery shopping
Theoretical Reading Distance: 50 cm

+2.75 SPEC SHEET (PDF - 294KB)

*The questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence.

**On a scale of 1-7, with glasses as needed.

†Patients implanted with the TECNIS® Multifocal IOL +2.75 D, model ZKB00.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL FAMILY OF 1-PIECE IOLs

Rx Only

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.

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. 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. 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°). 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.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

REFERENCES

  1. TECNIS® Multifocal 1-Piece IOL DFU, Models ZKB00 and ZLB00. Santa Ana, Calif. Abbott Medical Optics Inc.
  2. TECNIS® Multifocal 1-Piece IOL DFU, Model ZMB00. Santa Ana, Calif. Abbott Medical Optics Inc.
  3. Data on File, Abbott Medical Optics Inc., 2015.
  4. Data on File, Abbott Medical Optics Inc., 2013.
  5. Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS. 2010 Dec;36(12):2056-60.
  6. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27(5):728-733.
  7. Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. J Cataract Refract Surg. 2012;38(7):1140-1146.
  8. Gunenc U, et al. Effects on visual function of glistenings and folding marks in AcrySof® intraocular lenses. J Cataract Refract Surg. 2001;27(10):1611-1614.
  9. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013 Jul 11;4(8):1294-304.