Johnson & Johnson Highlights Innovations Shaping the Future of Cataract Care at AAO 2026

  • Company will showcase advancements across the cataract care journey, including leadership in contrast-preserving TECNIS intraocular lenses, the launch of SmartLOAD Delivery Technology for TECNIS Eyhance IOL, and enhancements to the VERITAS Vision System
  • TECNIS PureSee IOL and TECNIS Odyssey IOL surpass 1 million implants worldwide1, reflecting surgeon confidence in Johnson & Johnson’s advanced visual options for patients

Jacksonville, Fl. – October 5, 2026 – Johnson & Johnson today announced its scientific and educational program for the 2026 American Academy of Ophthalmology (AAO) Annual Meeting, highlighted by three milestones shaping the future of cataract care:

  • New data reinforcing Johnson & Johnson's leadership in image contrast and quality vision for patients
  • Continued momentum for the TECNIS portfolio as TECNIS PureSee IOL and TECNIS Odyssey IOL surpass 1 million implants worldwide[1]
  • The launch of SmartLOAD Delivery Technology, the first and only IOL delivery system to pair a reusable titanium inserter with a preloaded disposable cartridge[12].

"Today's cataract patients expect more than improved visual acuity alone," said Erin Powers, President, North America, Surgical Vision, MedTech, Johnson & Johnson. "They want confidence in daily activities across a variety of lighting conditions, and surgeons want technologies that help them consistently deliver excellent outcomes. Surpassing one million TECNIS PureSee IOL and TECNIS Odyssey IOL implants[1] underscores the enduring impact of the platform and Johnson & Johnson's leadership in shaping the future of cataract care through decades of innovation. We are proud to highlight that meaningful innovation at the AAO Annual Meeting.”

While visual acuity remains an important measure of surgical success, contrast can influence how patients perform everyday activities in varying lighting conditions, including driving, mobility and object recognition. At AAO, Johnson & Johnson will spotlight new data demonstrating that both TECNIS PureSee IOL and TECNIS Odyssey IOL delivered higher image contrast than leading competitive IOLs.

  • TECNIS PureSee IOL delivered higher image contrast in both daylight and low-light conditions[2,3*] and remains the first and only extended depth of focus (EDOF) IOL in the United States without a warning for loss of contrast sensitivity in its labeling[4,5**]. Most patients implanted with a leading competitive EDOF IOL are "likely to experience significant loss of contrast sensitivity as compared to a monofocal IOL," according to the warning included in its Directions for Use[5].
  • TECNIS Odyssey IOL delivered 40% higher image contrast during the day and more than two times higher image contrast in low-light conditions compared with a leading competitive IOL6,7, based on pre-clinical bench testing, while providing a full range of vision[8].

Now trusted in more than 1 million eyes globally[1], TECNIS PureSee IOL and TECNIS Odyssey IOL reflect Johnson & Johnson's continued leadership in premium cataract surgery, delivering differentiated solutions across the spectrum of patient lifestyle needs.

Expanding Innovation Beyond the Implant with SmartLOAD Delivery Technology

At AAO, Johnson & Johnson is launching SmartLOAD Delivery Technology with TECNIS Eyhance IOL, the first and only IOL delivery system to pair a reusable titanium inserter with a preloaded disposable cartridge[12], representing a new approach to efficiency and sustainability in cataract surgery. Developed in response to surgeon feedback, SmartLOAD Delivery Technology was designed to help address common challenges associated with lens loading, procedural efficiency, and waste generation in cataract surgery[9].

SmartLOAD Delivery Technology may help reduce risk factors associated with contamination during lens preparation^^ and demonstrated high surgeon satisfaction in clinical evaluations[10].

  • 93% of surgeons expected SmartLOAD Delivery Technology to reduce the number of IOL loading errors ^^10. 
  • 69% of surgeons strongly agreed that the delivery system would minimize the risk of infection and inflammation ^^10. 
  • 86% of surgeons were very satisfied with overall performance[+10] and 84% were very satisfied with ease of use [+10].

In addition to procedural benefits, SmartLOAD Delivery Technology generates:

  • 55% to 75% less product and primary packaging waste than competitive preloaded disposable systems[~11]
  • 49% less shipper packaging weight vs. single-use IOL inserters[11]
  • 47% smaller packaging footprint than the Simplicity box (by volume)[11]

Innovation Shaped by Surgeon Feedback 

Johnson & Johnson will also showcase enhancements to the VERITAS Vision System, reinforcing its commitment to continuous innovation across every step of the cataract procedure.

The updated ELLIPS FX Phaco Handpiece incorporates a new locking Luer connector that helps maintain a secure irrigation tubing connection throughout surgery, along with a lighter cable designed to enhance ergonomics, improve wrist mobility, and reduce surgeon fatigue. These enhancements were developed in response to surgeon feedback and are designed to provide a more seamless experience without changes to existing operation or maintenance procedures.

Attendees can experience Johnson & Johnson technologies firsthand through hands-on demonstrations and wet lab sessions at booth #2318.

 

Visit us at jnjvisionpro.com/en-us/ and follow Johnson & Johnson | Vision on LinkedIn.

Footnotes:

*25% increase in contrast was estimated from MTF measurements at 50c/mm for 3mm pupil. Visual perception can differ from simulations because contrast increase varies per spatial frequency and pupil size

**In clinical evaluation, TECNIS PureSee IOL demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences (≤0.3 log units) versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms.

^White light MTF at 50 c/mm measured for 3mm pupil in the ACE model

^^Compared with a non-preloaded system

+Ratings were on a scale from 1 (not satisfied/poor) to 5 (very satisfied/excellent); n=91 surgeons

~Calculated based on weight of one device, lens, tray and pouch of Alcon® AutonoMe® (37.88g), Hoya Vivinex™ (21.25g), and Alcon® UltraSert® (24.27g) delivery systems compared to SmartLOAD™ Delivery Technology (9.45g): September 2025. Primary packaging is for sterility and puncture resistance. Calculations did not include secondary or tertiary packaging for shipment purposes.

  1. 2026REF5830 - 1MM Implants Milestone - Internal Data
  2. DOF2020OTH4011 
  3. DOF2023CT4014
  4. TECNIS PureSee™ IOL, Model DEN00V, US DFU Z312075E rev B. Monocular mesopic contrast sensitivity at 6 months.
  1. 2024REF4215 Clareon® Vivity® Directions for Use. Monocular mesopic contrast sensitivity at 6 months
  1. Johnson & Johnson Vision. Data on File. DOF2019OTH4002. 
  2. Johnson & Johnson Vision. Data on File. DOF2023CT4007. 
  3. Data on File. DOF2023CT4023. Continuous 20/25 or better based on pre-clinical bench testing.
  4. Directions for Use 2025REF4758.
  5. Johnson & Johnson Vision (2019) Clinical handleability and acceptability assessment of the TITAN modular cartridge delivery system. IDEV-120-TTAN: 1-day clinical study. Data on file.
  6. Data on File; Johnson & Johnson; 2025DOF4013
  7. 2026REF5895 – First and only IOL delivery system to pair a reusable titanium inserter with a preloaded disposable cartridge.


INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS PureSee™ IOL and TECNIS PureSee™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery System 

 

Rx Only 


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 pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. 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 IOLs, which 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. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only. 


WARNINGS 

  1. Physicians should weigh the potential benefit/risk ratio of IOL implantation in patients with any of the conditions listed below, as intraocular lenses may exacerbate an existing condition or may pose an unreasonable risk to the eyesight of patients. The following conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general: 
    1. Recurrent severe anterior or posterior segment inflammation of unknown etiology 
    2. Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens 
    3. Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss) 
    4. Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible 
    5. Risk of damage to the endothelium during implantation 
    6. Suspected microbial infection 
    7. Congenital bilateral cataracts 
    8. Previous history of, or a predisposition to, retinal detachment 
    9. Potentially good vision in only one eye 
    10. Medically uncontrollable glaucoma 
    11. Corneal endothelial dystrophy 
    12. Proliferative diabetic retinopathy 
  2. Rotation of the toric lens 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. 
  3. 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. 
  4. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. 
  5. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. 
  6. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial lens advancement. Doing so may result in improper folding of the lens. 
  7. Do not advance the lens from the Holding Position prior to fully hydrating the system. 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 lens. 
  8. Do not advance the lens from the Holding Position until ready for implantation. Interruptions during delivery may result in the lens being scratched or cracked or stuck in the cartridge. Discard the device if the lens has been advanced past the Holding Position but not delivered within 60 seconds. 
  9. 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. 
  10. Johnson & Johnson Surgical Vision, Inc., 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 delivery system minimizes the risk of infection and/or inflammation associated with contamination. 
  11. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient contamination, transmission of infection, and lack of product sterility. 


PRECAUTIONS 

  1. 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. 
  2. Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. 
  3. This is a single-use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material of the IOL and the preloaded inserter material without producing undesirable side effects. 
  4. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C). 
  5. Do not autoclave the delivery system. 
  6. The contents are sterile unless the package is opened or damaged. 
  7. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised. 
  8. The recommended temperature for implanting the lens is at least 63°F (17°C). 
  9. Do not advance the lens unless ready for lens implantation. 
  10. Do not leave the lens in a folded position more than 10 minutes. 
  11. When the delivery system is used improperly, the lens may not be delivered properly (i.e., haptics may be broken). Please refer to the specific Directions For Use section provided. 
  12. The use of balanced salt solution or ophthalmic viscosurgical devices (OVDs) is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of OVDs. The use of balanced salt solution with additives has not been studied for this product. 
  13. The lens should be placed entirely in the capsular bag. The lens should not be placed in the ciliary sulcus. 
  14. 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 toric lens with the intended axis of placement. 
  15. Do not reuse. 
  16. 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. 
  17. The IOL is designed for optimum visual performance when emmetropia is targeted. 
  18. The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). 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 multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS™ Toric IOL U.S. IDE study and may yield results different from those in the TECNIS PureSee™ Toric II IOL labeling. Please refer to the TECNIS™ Toric IOL Calculator user manual for more information. 
  19. 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 TECNIS™ Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the TECNIS PureSee™ Toric II IOLs. 
  20. All preoperative surgical parameters are important when choosing a toric lens 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 the toric lens in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. 
  21. All corneal incisions were placed temporally in the TECNIS™ Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS™ Toric IOL. Note that the TECNIS™ Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. 
  22. Children under the age of 2 years are not suitable candidates for intraocular lenses. 
  23. The safety and effectiveness of the TECNIS PureSee™ IOLs have not been substantiated in pregnant women, patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions. 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. 

 

Before Surgery 

  • Pupil abnormalities 
  • Prior corneal refractive or intraocular surgery 
  • 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 
  • Irregular corneal astigmatism 
  • Amblyopia 
  • Macular disease 

 

During Surgery 

  • Excessive vitreous loss 
  • Non-circular capsulotomy/capsulorhexis 
  • The presence of radial tears known or suspected at the time of surgery 
  • Situations in which the integrity of the circular capsulotomy/ capsulorhexis cannot be confirmed by direct visualization 
  • Cataract extraction by techniques other than phacoemulsification or liquefaction 
  • Capsular rupture 
  • Significant anterior chamber hyphema 
  • Uncontrollable positive intraocular pressure 
  • Zonular damage 

 

  1. Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. 


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

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 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.

 

PRECAUTIONS

1. This is a single use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects.

2. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C).

3. Do not autoclave the delivery system.

4. Do not advance the lens unless ready for lens implantation.

5. The contents are sterile unless the package is opened or damaged.

6. The recommended temperature for implanting the lens is at least 63°F (17°C).

7. The use of balanced salt solution or ophthalmic viscosurgical devices (OVDs), is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of OVDs. The use of balanced salt solution with additives has not been studied for this product.

8. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/ or the lens may have been compromised.

9. When performing refraction in patients implanted with the lens, 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.

10. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design.

11. 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.

12. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.

13. Care should be taken to achieve centration of the intraocular lens in the capsular bag.

14. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of the device and provide them a copy of the patient information brochure.

15. Children under the age of 2 years are not suitable candidates for intraocular lenses.

16. The lens should not be placed in the ciliary sulcus.

17. 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 toric lens with the intended axis of placement.

18. The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). 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 multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS™ Toric IOL U.S. IDE study and may yield results different from those in the TECNIS Odyssey™ Toric II IOL labeling. Please refer to the TECNIS™ Toric IOL Calculator user manual for more information.

19. 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 TECNIS™ Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the toric lens.

20. All preoperative surgical parameters are important when choosing a toric lens 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.

21. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Odyssey™ and TECNIS Odyssey™ Toric II IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism.

22. All corneal incisions were placed temporally in the TECNIS™ Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS™ Toric IOL. Note that the TECNIS™ Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

23. Do not reuse.

24. The safety and effectiveness of the TECNIS Odyssey™ IOL and the TECNIS Odyssey™ Toric II IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions, such as pupil abnormalities, prior corneal refractive or intraocular surgery, acute or chronic ophthalmic diseases or conditions (see below for examples).

25. 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.

 

Before Surgery

· Pupil abnormalities

· Prior corneal refractive or intraocular surgery

· 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

· Irregular corneal astigmatism

· Amblyopia

· Macular disease

· Pregnancy

 

During Surgery

· Excessive vitreous loss

· Non-circular capsulotomy/capsulorhexis

· The presence of radial tears known or suspected at the time of surgery

· Situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed by direct visualization

· Cataract extraction by techniques other than phacoemulsification or liquefaction

· Capsular rupture

· Significant anterior chamber hyphema

· Uncontrollable positive intraocular pressure

· Zonular damage

 

26. Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. Adverse events that may be associated with use of the device include: IOL dislocation, tilt or decentration, visual symptoms requiring lens removal, residual refractive error, secondary surgical intervention (including IOL repositioning or removal).

27. Do not leave the lens in a folded position more than 10 minutes.

28. When the delivery system is used improperly, the lens may not be delivered properly, (i.e., haptics may be broken). Please refer to the specific instructions for use provided.

 

WARNINGS

1. 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 with:

a. Recurrent severe anterior or posterior segment inflammation of unknown etiology

b. Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens

c. Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss)

d. Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible

e. Risk of damage to the endothelium during implantation

f. Suspected microbial infection

g. Congenital bilateral cataracts

h. Previous history of, or a predisposition to, retinal detachment

i. Potentially good vision in only one eye

j. Medically uncontrollable glaucoma

k. Corneal endothelial dystrophy

l. Proliferative diabetic retinopathy.

2. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starbursts 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.

3. A reduction in contrast sensitivity compared to an aspheric monofocal IOL may be experienced by some patients under certain conditions. The physician should carefully weigh the potential risks and benefits for each patient, with special consideration of potential visual problems before implanting the lens in patients including those with macular disease, amblyopia, corneal irregularities, or other ocular disease that may cause present or future reduction in acuity or contrast sensitivity, and should fully inform the patient of the potential for reduced contrast sensitivity and to exercise caution when driving at night or in poor visibility conditions after implantation.

4. 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.

5. Rotation of the toric lens 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.

6. 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.

7. Do not use if the cartridge of the delivery system is cracked or split prior to implantation.

8. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system.

9. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial IOL advancement. Doing so may result in improper folding of the lens.

10. Do not advance the IOL from the Holding Position prior to fully hydrating the system. 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.

11. Do not advance the IOL from the Holding Position until ready for implantation. 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.

12. 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.

13. Johnson & Johnson Surgical Vision, Inc. 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 delivery system minimizes the risk of infection and/or inflammation associated with contamination.

14. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. 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.


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

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance™ IOL with SmartLOAD™ Delivery Technology

Rx Only

INDICATIONS FOR USE

The SmartLOAD™ Delivery Technology is used in combination with the UNFOLDER VITAN™ Inserter, Model DK9000, to fold and assist in inserting the TECNIS Eyhance™ IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is 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 SmartLOAD™ Delivery Technology or UNFOLDER VITAN™ Inserter or any of their components, as this can significantly affect the function and/or structural integrity of the design. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the SmartLOAD™ Delivery Technology. The lens and SmartLOAD™ Delivery Technology should be discarded if the lens has been folded within the cartridge for more than 10 minutes. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

PRECAUTIONS

The safety and effectiveness of the TECNIS Eyhance™ IOL has not been substantiated in clinical trials and the effects of the optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. Do not resterilize the lens or the SmartLOAD™ Delivery Technology. 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 SmartLOAD™ Delivery Technology. 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 SmartLOAD™ Delivery Technology. Do not use if the SmartLOAD™ Delivery Technology or UNFOLDER VITAN™ Inserter has been dropped or if any part was inadvertently struck while outside the shipping case.

ADVERSE EVENTS

The most frequently reported cumulative adverse event that occurred during the SENSAR™ 1-Piece IOL clinical trial was cystoid macular edema which occurred at a rate of 3.3%.

ATTENTION

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the VERITAS™ Vision System Rx Only

INDICATIONS FOR USE: The VERITAS™ Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements. 

IMPORTANT SAFETY INFORMATION: Risks and complications of cataract surgery may include corneal burn. This device is only to be used by a trained licensed physician. 

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

About Vision at Johnson & Johnson

Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at clearvisionforyou.com, follow @JNJVision on X, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook.

About Johnson & Johnson 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech on LinkedIn.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

©Johnson & Johnson and its affiliates 2026. All rights reserved.

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