TECNIS^™ Preloaded Delivery Systems

FOOTNOTES

^{^}Calculated based on weight of one device and lens (product) and tray and pouch (primary packaging) 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.

REFERENCES
1. SC2015OTH0068 The impact of a preloaded intraocular lens delivery system on operating room efficiency in routine cataract surgery.

2. TECNIS^™ Monofocal IOL with TECNIS SIMPLICITY^™ Delivery System (DCB00 (Z311584P) ).

3. Data on File. Delivery System Weights. 2025DOF4013.

4. REF2020OTH4845 Black_Clinical evaluation of a novel preloaded IOL_SmartLOAD_Clin Ophthalmol 2020_14_2291_2300.

5. REF2019OTH4431 Chung 2017 Preloaded and Non-Preload IOL delivery system.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for The TECNIS^™ 1-Piece IOL with the TECNIS SIMPLICITY^™ Delivery System

Rx Only

INDICATIONS

The 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 reuse, resterilize, reprocess, or autoclave the device. Do not store in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not advance the lens unless ready for IOL implantation. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balance salt solutions or ophthalmic viscosurgical devices (OVDs) is required when using the delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck whileoutside the shipping box. Do not leave the IOL in a folded position for more than 10 minutes.

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. Do not implant the lens if the rod tip does not advance the IOL or if it is jammed in the cartridge. 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 IOL. 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. 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. 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.

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%.

ATTENTION

Reference the Directions for Use for a complete listing of indications and important safety information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the TECNIS Eyhance^™ IOL with SmartLOAD^™ Delivery Technology

Rx Only

ATTENTION

Reference the Directions for Use labeling for a complete listing of indications and important safety information.

INDICATIONS

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.

PRECAUTIONS

The safety and effectiveness of the TECNIS Eyhance^™ IOL has not been substantiated in clinical trials. The effects of the TECNIS Eyhance^™ IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. MTF testing of the TECNIS Eyhance^™ IOL may aid the Surgeon in understanding the theoretical image quality expected with the TECNIS Eyhance^™ IOL compared to other J&J monofocal IOLs (AAB00 and ZCB00). However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the TECNIS Eyhance^™ IOL against the potential for risks and the lack of clinical data to characterize the impact of the TECNIS Eyhance^™ IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain preexisting ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.). 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. Some autorefractors utilize only the central part of the IOL to calculate the refraction of the eye and that is the region where the TECNIS Eyhance^™ deviates from the monofocal design which could result in a wrong estimation of the refraction. Manual refraction with maximum plus technique is strongly recommended. Recent contact lens usage may affect the patient's refraction; therefore, for patients who wear contact lenses, surgeons should establish corneal stability without contact lenses prior to determining IOL power. The lens is designed for optimum visual performance when emmetropia is targeted. Do not re-sterilize the lens or the SmartLOAD^™ Delivery Technology. 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 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). Do not leave the lens in a folded position more than 10 minutes. 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. The use of balance salt solution or viscoelastics is required when using the SmartLOAD^™ Delivery Technology. For optimal performance, use the HEALON^™ family of viscoelastics. The use of balanced salt solutions with additives has not been studies for this product. 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. The sterility of the SmartLOAD^™ Delivery Technology and/or the lens may have been compromised.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: 1. Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight. These conditions are not specific to the design of the lens and are attributed to cataract surgery and IOL implantation in general: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye. b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases. c. 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). d. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible. e. Circumstances that would result in damage to the endothelium during implantation. f. Suspected microbial infection. g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. h. Congenital bilateral cataracts. i. Previous history of, or a predisposition to, retinal detachment. j. Patients with only one good eye with potentially good vision, Medically uncontrollable glaucoma. k. Corneal endothelial dystrophy. l. Proliferative diabetic retinopathy. n. Children under the age of 2 years are not suitable candidates for intraocular lenses. 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. 3. Do not use if the modular cartridge tip is cracked or split prior to implantation. 4. Do not use the inserter if the rod tip appears nicked or damaged in any way because the rod may override and/or damage the IOL resulting in the need to exchange the IOL. 5. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the SmartLOAD^™ Delivery Technology. 6. 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. 7. 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. 8. Do not advance the IOL from the Holding Position until ready for implantation. Interruption during the delivery may result in the IOL being scratched or cracked or stuck in the cartridge. Discard the device if the IOL has been advance past the Holding Position but not delivered within 60 seconds. 9. The lens and SmartLOAD^™ Delivery Technology 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 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 SmartLOAD^™ Delivery Technology minimizes the risk of infection and/or inflammation associated with contamination. 11. The reuse/resterilization/reprocessing of Johnson and 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. 12. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. 13. The use of enzymatic cleaners and detergents is not recommended due to the potential for Toxic Anterior Segment Syndrome (TASS).

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).    

INDICATIONS AND IMPORTANT SAFETY INFORMATION for UNFOLDER VITAN^™ Inserter, Model DK9000

Rx Only

INDICATIONS

The UNFOLDER VITAN^™ Inserter, Model DK9000, is used in combination with the SmartLOAD^™ Delivery Technology to fold and assist in inserting Johnson & Johnson Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

PRECAUTIONS

Do not use if any component of the UNFOLDER VITAN^™ Inserter has been dropped or inadvertently struck while outside of the shipping case.

WARNINGS

1. Do not use if the cartridge of the SmartLOAD^™ Delivery Technology is cracked or split prior to implantation.

2. 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 IOL.

3. 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.

4. 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.

5. The IOL and SmartLOAD^™ Delivery Technology should be discarded if the IOL has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

6. 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.

7. The use of enzymatic cleaners and detergents is not recommended due to the potential for Toxic Anterior Segment Syndrome (TASS).

8. Do not implant the IOL if the rod tip does not advance the lens or if it is jammed in the SmartLOAD^™ Delivery Technology.

9. Do not use the inserter if the rod tip appears nicked or damaged in any way because the rod may override and/or damage the IOL resulting in the need to exchange the IOL.

10. Do not sterilize the UNFOLDER VITAN^™ inserter prior to performing the cleaning procedure

Warning (SmartLOAD^™ Delivery Technology ONLY) 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. The reuse/resterilization/reprocessing for 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 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 labeling for a complete listing of indications and important safety information.