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Important Safety Information – TECNIS® Multifocal IOL

Caution: Federal law restricts this device to sale by or on the order of a physician.

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 under any of the conditions described in the Directions for Use labeling 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. Under low-contrast conditions, 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.

Precautions: 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. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration.

Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2% of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction).

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

TECNIS<sup>®</sup> Multifocal IOL

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.

All distances.(1,2) All lighting.(1) All in 1-piece.

Discover What the TECNIS® Multifocal 1-Piece IOL can do for Your Patients

  • High level of spectacle independence(1)
  • Fully diffractive surface for pupil-independent performance(2)
  • Unmatched benefits of TECNIS® Multifocal IOL technology in a next-generation one-piece design
  • Excellent patient satisfaction(1)

The Difference is Night and Day


*In the average cataract patient

References

1. TECNIS® 1-Piece Acrylic Intraocular Lens (package insert). Santa Ana, Calif: Abbott Medical Optics Inc. 2. Terwee T, Weeber H, van der Mooren M, Piers P. Visualization of the retinal image in an eye model with spherical and aspheric, diffractive, and refractive multifocal intraocular lenses. J Refract Surg. 2008;24:223-32. 3. Data on file 117. Reading Distance of Multifocal IOLs. Santa Ana, CA; Abbott Medical Optics Inc. 4. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9):1225-29. 5. Mainster MA. Violet and blue light blocking intraocular lenses: photoprotection vs. photoreception. Br J Ophthalmol. 2006;90:784-792. 6. Data on file 150.

Lens Features

Designed for any Lighting Condition

Numerous lens attributes combine to deliver excellent vision in any lighting condition.

  • Spherical aberration correction provides sharper vision in low-light conditions1
  • The full diffractive posterior surface of the lens makes the optic pupil-independent2, especially important for low-light near vision
  • Full transmission of healthy blue light essential for optimal low-light vision1

Ease of Use

The TECNIS® Multifocal 1-Piece IOL next-generation design:

  • Controlled center thickness for consistency of insertion
  • ProTEC 360° edge design provides uninterrupted contact at the haptic optic junction to limit LEC migration4
  • TriFix design, offset haptics allow three points of capsular bag fixation designed to provide refractive predictability, long-term stability, and centration

The TECNIS® Multifocal 1-Piece IOL Advantage


*In the average cataract patient

References

1. Terwee T, Weeber H, van der Mooren M, Piers P. Visualization of the retinal image in an eye model with spherical and aspheric, diffractive, and refractive multifocal intraocular lenses. J Refract Surg. 2008;24:223-32. 2. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007;91(9):1225-29. 3. Mainster MA, Turner PL. Blue-blocking IOLs decrease photoreception without providing significant photoprotection. Surv Ophthalmol. 55:272-283,2010
4. Nixon J Cataract Refract Surg 36:929-924, 2010  5. TECNIS® Multifocal Foldable Acrylic Intraocular Lens (package insert). Santa Ana, Calif: Abbott Medical Optics Inc.

Clinical Results

With TECNIS® Multifocal IOL:

  • High level of spectacle independence1
  • Nearly 9 out of 10 patients NEVER wear glasses1
  • Nearly 90% of patients are able to function comfortably without glasses at ALL distances1
  • Excellent patient satisfaction1

Spectacle Usage (1 year)1

Ability to Function Comfortably Without Glasses1

Distance corrected binocular near visual acuity at best distance (1 year)1

References

1. TECNIS® 1-Piece Acrylic Intraocular Lens. Santa Ana, Calif: Abbott Medical Optics Inc.

Specifications


Reference

1. 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).

Information for Consumers

For consumer information on our TECNIS® Multifocal IOL please visit


Important Safety Information – TECNIS® Multifocal IOL

Caution: Federal law restricts this device to sale by or on the order of a physician.

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 under any of the conditions described in the Directions for Use labeling 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. Under low-contrast conditions, 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.

Precautions: 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. Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration.

Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS® Multifocal lens was macular edema, which occurred at a rate of 2.6%. Other reported reactions occurring in 0.3 – 1.2% of patients were hypopyon, endophthalmitis, and secondary surgical intervention (including biometry error, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning, and patient dissatisfaction).

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



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