*According to ISO 11979-7:2024, based on the clinical study of the parent IOL
**(n=82) 1 month results. Q: “Was the patient wearing any spectacles or contact lenses since the surgery?” Six subjects 6/82 (5 subjects for near, 1 subject for both distance and near);
***Based on 1-month postoperative data from a multicenter, retrospective, real-world clinical study in the U.S. evaluating visual and patient-reported outcomes from subjects bilaterally implanted with TECNIS Odyssey™ IOL (n=96).
****Based on 3-month postoperative data from a multicenter, observational clinical study in the U.S. evaluating visual and patient-reported outcomes from subjects bilaterally implanted with TECNIS Odyssey™ IOL (n=33).
¶based on pre-clinical bench testing. The third-party trademarks used herein are the trademarks of their respective owners.
∫compared to TECNIS Synergy™ and TECNIS™ Multifocal IOLs based on pre-clinical bench testing
#compared to PanOptix® based on pre-clinical bench testing
##compared to leading competitor full visual range IOLs based on pre-clinical bench testing (white light MTF at 50 c/mm measured for 3mm & 5mm pupil in the ACE model)
§Johnson & Johnson represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
†continuous 20/25 or better
‡based on pre-clinical bench testing
^based on Market Scope’s estimated procedure for 2024 vs 2023
^^^Professor Beatrice Cochener-Lamard is a paid consultant of Johnson & Johnson MedTech
~Compared to TECNIS SYNERGY™ based on bench testing
+Individual results will vary. Some TECNIS Odyssey™ IOL patients may require spectacles post-surgery.
-Results may vary. Consult your doctor to determine the lens options that are right for you.
$Compared to PanOptix® based on bench testing and head-to-head clinical studies of parent lens
&Values rounded to the nearest 1%
Indication and safety information in regions where these products are available for use is included below. Please note indications may differ based on region. Full safety information is available hyperlinked below.
IN THE UNITED KINGDOM
The promoted product is a medical device. For healthcare professionals only.
Please reference the Instructions for Use for a complete list of Indications and Important Safety Information and contact our specialists in case of any question.
IN CANADA
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS ODYSSEY™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DRN00V AND TECNIS ODYSSEY™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELS DRT100, DRT150, DRT225, DRT300, DRT375, IN CANADA:
Rx Only
INDICATIONS FOR USE: The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients with or without presbyopia, in whom a cataractous lens has been removed. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ Toric II IOLs which are indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with or without presbyopia, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing vision far through near and reduced spectacle dependence across a range of distances. The lens is intended to be placed in the capsular bag.
WARNINGS:
Intraocular lenses may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the eyesight of patients. Patients should have well-defined visual needs and be informed of the possibility of visual effects (such as halo or glare), in nighttime or poor visibility conditions. Patients may perceive these visual effects as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully benefit in terms of potential spectacle independence. Rotation of the TECNIS Odyssey™ Toric II IOL 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. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Do not attempt to disassemble, modify, or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design.
PRECAUTIONS:
Interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. The TECNIS Odyssey™ IOLs should not be placed in the ciliary sulcus. 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 Odyssey™ Toric II IOL. Care should be taken to achieve centration of the toric IOL. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies.
ATTENTION:
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS PURESEE™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, AND TECNIS PURESEE™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM IN CANADA
INDICATIONS FOR USE
The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL which is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed. The lens is intended to correct presbyopia by providing improved vision over a continuous range of distances including far, intermediate, and near, and decreased spectacle dependence. The lens is intended for capsular bag placement only.
The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOL which is indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia in whom a cataractous lens has been removed. The lens is intended to correct presbyopia by providing improved vision over a continuous range of distances including far, intermediate, and near, a reduction of residual refractive cylinder, and decreased spectacle dependence. The lens is intended for capsular bag placement only.
WARNING
Physicians should weigh the potential risk/benefit ratio of IOL implantation in patients with any of the conditions described in the Directions for Use. These conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general. The IOL should be placed entirely in the capsular bag. Do not place the IOL in the ciliary sulcus. Patients should be informed of the possibility of visual disturbances. The lens may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made for patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions.
Rotation of the TECNIS PureSee™ Toric II IOL away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, IOL repositioning should occur as early as possible prior to lens encapsulation.
Do not attempt to disassemble, modify, or alter the delivery system, or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge tip is cracked or split. Do not implant the IOL if the rod tip does not advance the IOL or if it is jammed in the delivery system. Do not advance the IOL from the Holding Position (located at the half turn rotation position for the initial advancement of the IOL into the cartridge) prior to fully hydrating the system and ready for implantation. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the IOL. Interruptions during delivery may result in the IOL being scratched or cracked or stuck in the cartridge. Discard the device if the IOL has been advanced past the Holding Position but not delivered within 60 seconds. The IOL and delivery system should be discarded if the IOL has been folded within the cartridge for more than 10 minutes. Not doing so may result in the IOL being stuck in the cartridge.
PRECAUTIONS
Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Target emmetropia for optimum visual performance.
For the TECNIS PureSee™ Toric II IOL, variability in any preoperative surgical parameters (e.g., keratometric cylinder, incision location, estimated surgically induced astigmatism, or biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case, to avoid lens rotation.
This is a single use device, do not resterilize the lens or the delivery system. 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 delivery system. 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 (63°F). The use of balanced salt solution or viscoelastics is required when using the delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box.
ADVERSE EVENTS
Potential adverse events during or following cataract surgery with implantation of the IOL may include but are not limited to: Endophthalmitis/intraocular infection, IOL dislocation, persistent cystoid macular edema, persistent corneal stromal edema, persistent raised intraocular pressure (IOP) requiring treatment, secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure). Adverse events can lead to permanent visual impairment and may require secondary surgical intervention, including intraocular lens exchange or explanation.
ATTENTION
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
IN THE UNITED STATES
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS ODYSSEY™ IOL WITH
TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DRN00V AND TECNIS ODYSSEY™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELS DRT150, DRT225, DRT300, DRT375 IN THE UNITED STATES
Rx Only
INDICATIONS:
The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The
TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ Toric II IOLs that are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS Odyssey™ IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.
WARNINGS:
Intraocular lenses may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the eyesight of patients. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starburst or glare around lights), which may be expected in nighttime or poor visibility conditions. Patients may perceive these visual effects as bothersome, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. The physician should carefully weigh the potential risks and benefits for each patient. Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully benefit in terms of reducing spectacle wear. Rotation of the TECNIS Odyssey™ Toric II IOL 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. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Do not attempt to disassemble, modify, or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design.
PRECAUTIONS:
Interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. The TECNIS Odyssey™ IOLs should not be placed in the ciliary sulcus. 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 Odyssey™ Toric II IOL. All preoperative surgical parameters are important when choosing a TECNIS Odyssey™ Toric II IOL for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon's estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of TECNIS Odyssey™ Toric II IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism < 1.0 diopter has not been demonstrated. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the
TECNIS Odyssey™ IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower predicted postoperative astigmatism.
ATTENTION:
Reference the Directions for Use for a complete listing of Indications and Important Safety Information found here: https://www.jnjvisionpro.com/en-us/important-safety-information/?tab=2
-------------------------------------------------
1 Data on File. 2024DOF4002 (prospective, multicenter, randomized, three-way-masked clinical study comparing subjects
bilaterally implanted with TECNIS Synergy IOL (n=132) vs TECNIS 1-Piece Monofocal IOL (n=131) at 6-months post-op)
2 Data on File. DOF2023CT4051.
3 Data on File. 2024DOF4033
4 Data on File. DOF2019OTH4002
5 Data on File. DOF2023CT4007
6 Data on File. DOF2023CT4023
7 Data on File. 2024DOF4003
8 World report on vision. Geneva: World Health Organization, 2019. Available at: https://apps.who.
int/iris/bitstream/handle/10665/328717/9789241516570-eng.pdf. Last accessed: May 2025.
9 What Is Presbyopia – American Academy of Ophthalmology. Access from:
https://www.aao.org/eye-health/diseases/what-is-presbyopia. 2024REF5075.
11 Data on File. 2024DOF4017
12 Data on File. 2024DOF4027.
13 Data on File. 2024DOF4029.
14 Data on File. 2024DOF4005
15 DOF2023CT4052
16 DOF2020CT4014
# # #
2025PP10401