TECNIS Monofocal 1-Piece IOL / Toric II IOL

TECNIS™ Monofocal 1-Piece IOL
High quality vision starts with the strength of the TECNISTM IOL Platform.
Also available in Toric II.
TECNIS™ Monofocal 1-Piece IOL
High quality vision starts with the strength of the TECNISTM IOL Platform.
Also available in Toric II.

Key Features

Unmatched contrast, day and night*1

TECNISTM material induces the least amount of chromatic aberration.

Sharp quality of vision2

TECNIS IOLs are the first and only IOLs that correct spherical aberration (SA) to essentially zero.

Sustained optical clarity and stability3-5

TECNIS IOL material is not associated with glistenings.5

TECNISTM Toric II Engineered for rotational stability**

TECNIS Toric II frosted haptics

Advanced design has squared, frosted haptics for increased friction in the capsular bag6. 100% of surgeries had ≤ 5 degrees rotation at 3 months**7.

Learn More

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Cataract Vision Simulator

Check out our Vision Simulator to better understand the visual benefits of our different IOL options.

FOOTNOTES

* Compared to Clareon® and enVista® IOL platforms.

**Based on data from 200 eyes after 3 months post-operative follow-up in a post-market prospective, multicenter, single-arm, open-label study in the U.S. Outcomes differ from the pivotal investigation data in the product labeling and was collected using different measurement methods, study design and clinical conditions.

REFERENCES
1. Data on file. 2018CT4007. Johnson & Johnson Surgical Vision, Inc. Acrysof® Clareon® equivalent.

2. Data on file. TECNIS 1-Piece IOL [Package Insert] DFU.

3. Data on file. 2019OTH4002.

4. Data on file. 2024DOF4033.

5. Data on file. REF2014OTH0002 150. Sensar Not Associated With Glistenings – Literature Analysis

6. Data on file. DOF2019OTH4015.

7. Data on file. DOF2021CT4019.

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
Rx Only

INDICATIONS
Johnson & Johnson 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 TECNIS TORIC II 1-PIECE IOL

Rx Only

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. The clinical study for the TECNIS Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal  astigmatism of < 1.0 diopter. The TECNIS Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS Toric 1-Piece IOL away from its intended  axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Do not soak or rinse with any solution other than sterile balanced salt solution or sterile normal saline. Do not store in  direct sunlight or at greater than 113°F. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or  over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS Toric 1-Piece IOL with the intended axis of placement. When the insertion system is used improperly, the haptics of the TECNIS Toric 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. The use of methods other than the TECNIS Toric IOL Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinicalstudy and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator  (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been  substantiated in patients with certain preexisting ocular conditions, and intraoperative complications. Careful preoperative evaluation and sound clinical judgment  should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Pre-existing conditions include: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, or irregular corneal  astigmatism. Intraoperative conditions include: excessive vitreous loss, capsulotomy by any technique other than a circular tear, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques  other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow  eye, peripheral retinal pathology, etc.), capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. All  preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS Toric IOL multi-center clinical study. The PCA algorithm forthe selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS Toric intraocular lens labeling. Please  refer to the Johnson & Johnson Surgical Vision Toric Calculator user manual for more information. Variability in any of the preoperative measurements can influence  patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, pupillary block, retinal detachment, IOL dislocation, persistent corneal stromal edema, persistent cystoid macular edema, or secondary surgical intervention (including implant repositioning, removal, or other surgical procedure). The most frequently reported cumulative adverse event that occurred during the TECNIS Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

ATTENTION

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

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