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THE TECNIS® FAMILY

Vision for What They Love.

Stay ahead of rising expectations with a complete portfolio designed to empower visual freedom in each patient’s life – all from the leader in presbyopia-correcting (PC) IOLs.

REFERENCES

  1. TECNIS Symfony® Extended Range of Vision IOLs DFU. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.
  2. TECNIS® Multifocal 1-Piece IOL DFU, Models ZKB00 and ZLB00. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.
  3. TECNIS® Multifocal 1-Piece IOL DFU, Model ZMB00. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.
  4. Freeman R. 2017 IOL Report: A Global Market Analysis for 2016 to 2022. Marketscope. Prepared 2017
  5. Department of Health & Services. CMS Recognized presbyopia-correcting (PC) IOL and astigmatism- correcting (AC) IOLs. Baltimore, MD: Department of Health & Services; 2005
  6. Data on File, Johnson & Johnson Surgical Vision, Inc. 2016 [DOF2016CT0025]
  7. Data on File, Johnson & Johnson Surgical Vision, Inc. 2016 [SC2016OTH0004]
  8. Data on File, Johnson & Johnson Surgical Vision, Inc. 2015 [DOF2015CT0015]
  9. Data on File, Johnson & Johnson Surgical Vision, Inc. 2017 [DOF2017CT0009]
  10. TECNIS ® 1-Piece IOL [package insert]. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc. 2016
  11. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. BR J Opthalmol. 2007; 91 (9): 1225-1229
  12. Data on File, Johnson & Johnson Surgical Vision, Inc. 2015 [REF2014OTH0002]
  13. Kahraman G, Ferdinaro C, Wetzel B, Bernhart C, Prager F, Amon M., Intraindividual comparison of capsule behavior of 2 hydrophobic acrylic intraocular lenses during 5 year follow up. J Cataract Refract Surg. 2017; 43:228-233.
  14. Data on File, Johnson & Johnson Surgical Vision, Inc. 2015 [REF20150200]
  15. TMF Directions For Use.

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

Rx Only

TECNIS® MONOFOCAL 1-PIECE IOL WITH TECNIS iTec® PRELOADED DELIVERY SYSTEM
INDICATIONS

TECNIS® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extra capsular 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 reuse/resterilization/reprocessing of AMO single-use devices 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.

See Full Indications and Important Safety Information.

TECNIS® TORIC 1-PIECE IOL
INDICATIONS

The TECNIS® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or uveitis; 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); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses.

See Full Indications and Important Safety Information.

TECNIS® MULTIFOCAL FAMILY OF 1-PIECE IOLs
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.

See Full Indications and Important Safety Information.

TECNIS Symfony® AND TECNIS Symfony® TORIC EXTENDED RANGE OF VISION IOLs

The TECNIS Symfony® Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symfony® Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.

WARNINGS

Physicians considering lens implantation under any of the circumstances described in the Directions for Use should weigh the potential risk/benefit ratio as such patients 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.

See Full Indications and Important Safety Information.

ATTENTION

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

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