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IMPORTANT INDICATIONS AND SAFETY INFORMATION – TECNIS® Multifocal Family of 1-Piece IOLs

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 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°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).

TECNIS<sup>®</sup> Multifocal Family of 1-Piece IOLs

Give your patients a full range of outstanding vision with enhanced performance at distances tailored to their daily activities. Backed by proven IOL technology, the TECNIS® Multifocal Family of 1-Piece IOLs now offers three lens options so you can tailor your choice of IOL to your patient’s lifestyle.

Each TECNIS® Multifocal IOL delivers:

  • A full range of outstanding vision across near, intermediate and far distances
  • Enhanced performance tailored to your patients’ lifestyles
  • High performance* in any lighting conditions1
  • A high degree of spectacle independence
  • High patient satisfaction

* Binocular best corrected distance contrast sensitivity

IMPORTANT SAFETY INFORMATION

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 complete Indications and Safety Information below.

Ability to Function Comfortably Without Glasses at All Distances (6 Months)1

Chart: Ability to function comfortably without glasses at All Distances
ZM900 (+4.0 D) data are historical from a separate clinical study using the same test methodology.

Personalized Outcomes

The TECNIS® Multifocal Family of 1-Piece 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.

NEW - TECNIS Multifocal IOL Diffractive Aspheric +2.75

New +2.75 D IOL for enhanced intermediate vision activities (~50 cm theoretical reading distance)

  • Outstanding vision across all distances (near, intermediate and far)
  • Enhanced performance for patients favoring longer intermediate-vision activities such as reading labels while grocery shopping
  • 98% of patients reported an ability to function comfortably without glasses at intermediate and far distances1
  • 97% of patients reported they would have the same IOL implanted again1

NEW - TECNIS Multifocal IOL Diffractive Aspheric +3.25

New +3.25 D IOL for enhanced closer intermediate vision (~42 cm theoretical reading distance)

  • Outstanding vision across all distances (near, intermediate and far)
  • Enhanced performance for patients favoring activities at closer intermediate distances such as reading a hand-held device, such as a tablet
  • More than 96% of patients reported an ability to function comfortably without glasses at intermediate and far distances1
  • 94% of patients reported they would have the same IOL implanted again1

NEW - TECNIS Multifocal IOL Diffractive Aspheric +4.0

+4.0 D IOL for enhanced near vision (~33 cm theoretical reading distance)

  • Outstanding vision across all distances (near, intermediate and far)
  • Optimized for patients favoring near-vision activities such as reading and knitting
  • 85% of patients reported an ability to function comfortably without glasses at ALL distances (near, intermediate and far)1
  • 87% of patients reported they would have the same IOL implanted again1

Binocular Defocus Curve at 6 Months (Bilateral Subjects)1

Chart: Binocular Defocus Curve at 6 Months (Bilateral Subjects)
ZM900 (+4.0 D) data are historical from a separate clinical study using the same test methodology.
Distances (cm) in the graph are approximate.

High Performance

TECNIS® Multifocal IOLs are engineered for high visual performance* in any lighting conditions1 — including minimal reports of halos and night glare.

* Binocular best corrected distance contrast sensitivity

Spontaneous Reports of Halos in a Non-Directed Study

Chart: Spontaneous Reports of Halos in a Non-Directed Study
Non-directed responses from open-ended questions. First-eye results only.

Spontaneous Reports of Night Glare in a Non-Directed Study

Chart: Spontaneous Reports of Night Glare in a Non-Directed Study
Non-directed responses from open-ended questions. First-eye results only.

Unique Design

With the TECNIS® Multifocal Family of 1-Piece IOLs, you get a new range of lens options paired with proven TECNIS® IOL design.

  • Reduced chromatic aberration for improved optical quality2
  • Wavefront-designed aspheric surface to correct spherical aberration to essentially zero3
  • Lens material that is not associated with glistenings4
  • UV-only blocking for full transmission of healthy blue light5
  • 360° square edge with frosted design to reduce potential edge glare effects6
  • Quality design and proprietary manufacturing process to ensure performance and consistency

IMPORTANT INDICATIONS AND SAFETY INFORMATION – TECNIS® Multifocal Family of 1-Piece IOLs

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 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°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).

References

  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. Mainster MA. Violet and blue-light blocking intraocular lenses: photoprotection versus photoreception. Br J Ophthalmol. 2006;90:784-792.
  5. Nixon DR. New technologies for premium outcomes: next generation phaco and TECNIS 1-Piece IOL. Presented at 25th Congress of ESCRS 2007, Stockholhm, Sweden.
  6. 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).

To learn more, please contact us for additional information.



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