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TECNIS® 1-Piece IOL

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FOOTNOTES

*A-Constant theoretically derived for ultrasound biometry.

**Derived from clinical evaluation results of the 1-Piece IOL Platform for optical biometry.

REFERENCES

  1. Data on File. Abbott Medical Optics Inc. 2015.
  2. TECNIS® Foldable Posterior Chamber Intraocular Lens [package insert]. Santa Ana, Calif. Abbott Medical Optics Inc.
  3. Data on File. Abbott Medical Optics Inc. 2015.
  4. Data on File. Abbott Medical Optics Inc. 2015.
  5. Data on File. Abbott Medical Optics Inc. 2013.
  6. Nagata M, Matsushima H, Mukai K, Terauchi W, Senoo T, Wada H, Yoshida S. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010;36(12):2056-2060.
  7. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27(5):728-733.
  8. 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.
  9. 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.
  10. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013;4(8):1294-1304.
  11. Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruis RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24.

LEAVE A LASTING LEGACY

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TECNIS® Family of IOLs

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS® MONOFOCAL 1-PIECE IOL

Rx Only

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 extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. 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 TECNIS® 1-Piece Lens may become damaged.

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. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; 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. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus.

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).

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS iTec® PRELOADED DELIVERY SYSTEM

INDICATIONS

AMO TECNIS® 1-piece lenses are 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 Directions for Use that could increase complications or impact patient outcomes. Do not attempt to disassemble, modify or alter the device or any of its components.

See Full Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE UNFOLDER® PLATINUM 1 SERIES IMPLANTATION SYSTEM

INDICATIONS

The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting AMO Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag. 

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The UNFOLDER® Platinum 1 Series Implantation System should be used ONLY with AMO Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube.

See Full Indications and Important Safety Information.

ATTENTION

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

PP2018MLT4018