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TECNIS® CL IOL

TECNIS® CL IOL

 

 

Full, Brilliant Vision

The TECNIS® CL IOL (silicone) delivers ultraviolet-absorbing technology and corrects for corneal spherical aberrations — all in a foldable silicone design. 

Three-piece silicone TECNIS® IOLs offer:

  • Reduction of spherical aberration to essentially zero
  • Full transmission of visible light
  • Effective UV protection
  • Proven biocompatibility1

Best Case Visual Acuity Results2

 

AGE

N

Percent of “Best Case” Patients with Visual Acuity of 20/40 or Better

TECNIS® CL 3-Piece IOL

FDA Grid

<60

11

100%

96.9%

60–69

73

100%

93.8%

70–79

139

98%

94.9%

> 79

52

98%

87.9%

Total

275

99%

94.0%

TECNIS® CL Silicone IOL (Z9002)1

OPTIC CHARACTERISTICS

Powers:

+6.0 D to 30.0 D in 0.5 diopter increments

Diameter:

6.0 mm

Shape:

Biconvex, anterior aspheric surface, OptiEdge Design

Material:

UV-blocking SLM-2 Silicone

Refractive Index:

1.46 at 35° C

CONSTANTS

Nominal (theoretically calculated)

A-Constant:

118.7

AC Depth:

5.40 mm

Surgeon Factor:

1.62 mm

HAPTIC CHARACTERISTICS

Overall Length:

13.0 mm

Style:

Modified C

Material:

60% Blue-core Polymethylmethacrylate (PMMA) Monofilament

Angle:

10˚

Average Weight in Air:

19.3 mg

IOL INSERTION

Recommended insertion instruments:

 

REFERENCES

  1. 1. Internal Data. Johnson & Johnson Surgical Vision. 2002.
2. TECNIS® CL [package insert]. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.
 

IMPORTANT SAFETY INFORMATION FOR TECNIS® CL 3-PIECE IOLs

Rx Only

INDICATIONS

TECNIS® CL Silicone intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices 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 labeling should weigh the potential risk/benefit ratio prior to implanting a lens. These conditions include: 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 distorted 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, since the clinical study of parent lens model 911A was conducted with the lens implanted in the capsular bag, there are insufficient clinical data to demonstrate the safety and efficacy for placement in the ciliary sulcus, children under the age of 2 years are not suitable candidates for intraocular lenses, the use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease that may require silicone oil as part of therapy should be reconsidered. Johnson & Johnson Surgical Vision IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical 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.

PRECAUTIONS

Do not resterilize the lens as this can produce 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 45°C. Do not autoclave the intraocular lens. Avoid exposure to volatile chemicals. Do not reuse the lens.

ADVERSE EVENTS

The most frequently reported adverse event that occurred during the clinical trials of the parent lens models for the TECNIS® CL intraocular lens was corneal edema (upper and lower corneal edema), which occurred at a combined rate of 10.9%. The second most frequent adverse event was iritis, which occurred at a rate of 7.9%. Macular edema was the third most frequently reported adverse event, which occurred at a rate of 3.8%. Other reported reactions occurring in less than 2% of patients were hyphema, secondary glaucoma, cyclitic membrane, vitritis, surgical intervention (penetrating keratoplasty, lens replacement, and lens removal, lens repositioning, wound leak repair, and focal laser therapy), corneal decompensation and endophthalmitis.

ATTENTION

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

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

Rx Only

INDICATIONS

The UNFOLDER® Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS® Silicone, and ARRAY Silicone ≤ 24.0 D IOLs only, into the eye.

WARNINGS

The UNFOLDER® Silver Series Implantation System should only be used with the intraocular lenses listed in the Indication for Use section. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. The lens, cartridge, and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. Never reverse the rod direction until the optic body has been completely released. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. If the IOL is not properly placed in the cartridge, the IOL may flip and be implanted upside down. The UNFOLDER® Silver Series Implantation Cartridge, Silver Series SofTip Sheath, and Silver Series SofTip Applicator are intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. Do not advance an IOL through a given cartridge more than once. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Never use the UNFOLDER® Implantation System without a SofTip Sheath applied to the end of the handpiece rod. Always ensure that the SofTip Sheath is fully engaged on the handpiece rod tip. If it is not, use your sterile-gloved finger to engage the tip firmly against the shoulder of the rod. Avoid methylcellulose viscoelastics. Follow the dwell recommendations for advanced position of the IOL.

WARNING (Cartridge Only):

JJSV 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. The reuse/resterilization/reprocessing of JJSV single-use medical 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.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Do not use the cartridge if the package has been damaged. Overall system performance will be impaired when used in combination with non JJSV product. The usage of a viscoelastic is required when loading the IOL into the UNFOLDER® Cartridge. Do not use balanced salt solution. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F (5°C) or over 86°F (30°C). For optimal performance use the AMO HEALON® Ophthalmic Viscoelastic Solution.

ATTENTION

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

PP2021CT4024