SURGICAL
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THE LENS YOU TRUST, PRELOADED FOR SAFETY AND EFFICIENCY

The TECNIS iTec® Preloaded Delivery System brings the optical excellence of the TECNIS® Monofocal 1-Piece IOL to the convenience of touch-free IOL delivery. Designed to provide the sharpest vision, enhanced functionality and long-term sustainability of the TECNIS® Monofocal 1-Piece IOL, the TECNIS iTec® Preloaded Delivery System can help bring added safety and efficiency to your cataract procedures.

SAFETY & EFFICIENCY

The TECNIS iTec® Preloaded Delivery System is designed for optimal procedural predictability. With its preloaded TECNIS® Monofocal 1-Piece IOL, the TECNIS iTec® Preloaded Delivery System helps you deliver the IOL with added safety:

  • Reduces the risk of infection and inflammation associated with contamination
  • Eliminates IOL touches
  • Eliminates loading errors

Preloading the IOL also helps deliver practice productivity. Without the need to manually load an IOL, you’ll have faster, more efficient procedures that can add up to measurable improvements in OR efficiency:*2

  • Up to 12% reduction in total case time
  • One additional surgery per day
  • Up to 44% reduction in total surgeon lens time
  • Up to 10% increase in total annual case throughput

Mean Total Case Times by Study Site*2

Up to 12% reduction in total case time

Total Surgeon Lens Time by Study Site*,**2

Up to 44% reduction in total surgeon lens time

TECNIS iTec® Preloaded Delivery System

Compatible With

TECNIS® Monofocal 1-Piece IOL

Incision Size

2.2-2.4 mm

Delivery System

Screw-style

Injector Type

Disposable

CONTACT

Start a TECNIS® IOL trial

LEAVE A LASTING LEGACY

The lens you leave is the life your patients live. Why trust anything less than the very best in optic design?

TECNIS® Family of IOLs

RESOURCES

Directions for Use (PDF)

FOOTNOTES

*Individual results may vary.

**Total Surgeon Lens Time is defined as the time the surgeon spends loading, inserting, and positioning the lens in the eye.

REFERENCES

  1. TECNIS® Monofocal IOL with iTec Preloaded Delivery System [package insert]. Santa Ana, Calif. Abbott Medical Optics Inc.
  2. Data on File, Abbott Medical Optics Inc., 2015.

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

Rx Only

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.

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® MONOFOCAL 1-PIECE IOL WITH TECNIS iTEC® PRELOADED DELIVERY SYSTEM

Rx Only

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 under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with 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 defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; 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. Do not attempt to disassemble, modify or alter this device or any of its components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated for use with the TECNIS iTec® Preloaded Delivery System. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for lens implantation. Discard the device if the lens has been fully advanced for more than 1 minute. AMO single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the TECNIS iTec Preloaded Delivery System minimizes the risk of infection and/or inflammation associated with contamination. 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. The TECNIS® 1-piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

PRECAUTIONS

Do not resterilize the lens or the TECNIS iTec® Preloaded Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the device. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C. The combination of low operating room temperatures and high IOL diopter powers may require slower delivery. The use of viscoelastics is required when using the TECNIS iTec® Preloaded Delivery System. For optimal performance, use the AMO HEALON family of viscoelastics. The use of balanced salt solution alone is not recommended. Do not use if the TECNIS iTec® Preloaded Delivery System has been dropped or if any part was inadvertently struck while outside the shipping case.

ADVERSE EVENTS

In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).

ATTENTION

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

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