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INDICATIONS AND IMPORTANT SAFETY INFORMATION - TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery System

CAUTION: Federal law restricts this device to sale by or on the order of a physician.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information.
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 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.
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.
ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. 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).


Excellence now comes preloaded.

Predictability: Highly-controlled, screw-style system with planar delivery via 2.2 mm–2.4 mm incision size - Efficiency: Saves time associated with IOL loading, sterilization and inventory management and simplifies staff training - Safety: No-touch, disposable system helps minimize risk of infection - High-Quality Visual Outcomes: Proven outcomes associated with TECNIS<sup>®</sup> IOLs

Predictability

The TECNIS iTec Preloaded Delivery System offers a precise, highly-controlled, screw-style system exclusively designed to deliver exceptional predictability in your OR.

Preloaded

Demonstration Video

Predictable Delivery in Three Simple Steps (PDF-230KB) »

Tips for Successful IOL Implantations (PDF-254KB) »

Complete Product Specifications (PDF-238KB) »

Efficiency

Streamline IOL delivery, preparation, and management.

  • Saves time associated with:
    • IOL Loading
    • Sterilization
    • Inventory Management

Safety

Help reduce handling risks with no-touch, disposable system.

  • No-touch, single-use system
  • Helps minimize risk associated with IOL handling and loading
    • Infection
    • Sterilization errors
  • Not made with natural rubber latex

High-Quality Visual Outcomes

TECNIS® 1-Piece lenses are backed by proven IOL technology, including aspheric optics, clear lens material1 and precision-engineered design.

  • Helps provide patients with:
    • Excellent visual acuity
    • Sharper vision — wavefront-designed surface provides near-zero spherical aberration1,2
    • Improved scotopic sensitivity3 and transmission of healthy blue light
    • Reduced lens epithelial (LEC) migration4-7

Diamond cryolathing manufacturing process ensures optimum precision and quality

TECNIS® IOLs are made with a hydrophobic acrylic lens material, which is not associated with glistenings.8 The above image shows glistenings in an AcrySof® IOL after 18 months

Specifications

TECNIS iTec Preloaded Delivery System (PCB00)
Incision Size: 2.2 mm–2.4 mm
Delivery System: Screw-style
Injector Type: Disposable
TECNIS® 1-Piece Monofocal IOL
OPTIC CHARACTERISTICS
Power Range: +5.0 D to +34.0 D in 0.5 diopter increments
Diameter: 6.0 mm
Shape: Biconvex, anterior aspheric surface, square optic edge
Material: UV-blocking hydrophobic acrylic
Refractive Index: 1.47
Edge Design: ProTEC frosted, continuous 360° posterior square edge
BIOMETRY
A-constant: 119.3 (Optical Biometry)
  118.8 (Ultrasound Biometry-Contact)
HAPTIC CHARACTERISTICS
Overall Length: 13.0 mm
Style: C
Material: UV-blocking hydrophobic acrylic
Design: Haptics offset from optic

Predictability

The TECNIS iTec Preloaded Delivery System offers a precise, highly-controlled, screw-style system exclusively designed to deliver exceptional predictability in your OR.

Preloaded


INDICATIONS AND IMPORTANT SAFETY INFORMATION - TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery System

CAUTION: Federal law restricts this device to sale by or on the order of a physician.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information.
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 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.
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.
ADVERSE EVENTS: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. 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).

References

  1. TECNIS® 1-Piece Intraocular Lenses [package insert]. Santa Ana, Calif.: Abbott Medical Optics Inc.
  2. Terwee T, van der Mooren M, Piers P. Optical performance of TECNIS IOLs compared with IOLs that partly compensate for the mean SA of the human cornea. Presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; April 4-9, 2008; Chicago, Ill.
  3. Mainster MA. Violet and blue-light blocking intraocular lenses: photoprotection versus photoreception. Br J Ophthalmol. 2006;90:784-792.
  4. Nixon DR. New technologies for premium outcomes: next generation phaco and TECNIS® 1-Piece IOL. Presented at: 25th Congress of the European Society of Cataract and Refractive Surgeons; September 8-12, 2007; Stockholm, Sweden.
  5. Sacu S, Menapace R, Buehl W, Rainer G, Findl O. Effect of intraocular lens optic edge design and material on fibrotic capsule opacification and capsulorhexis contraction. J Cataract Refract Surg. 2004;30:1875-1882.
  6. Boyce JF, Bhermi GS, Spalton DJ, El-Osta AR. Mathematical modeling of the forces between an intraocular lens and the capsule. J Cataract Refract Surg. 2002;28(10):1853-1859.
  7. Peng Q, Visessook N, Apple DJ, et al. Surgical prevention of posterior capsule opacification. Part 3: Intraocular lens optic barrier effect as a second line of defense. J Cataract Refract Surg. 2000;26(2):198-213.
  8. Data on file. Abbott Medical Optics Inc.

Acrysof is a trademark of Novartis AG Corporation.



PP2014OTH0087