TECNIS SIMPLICITY^™ Delivery System

FOOTNOTES

*Derived from clinical evaluation results of the 1-Piece IOL Platform for optical biometry.
† A-Constant theoretically derived for ultrasound biometry.

REFERENCES
1. TECNIS Monofocal IOL with TECNIS SIMPLICITY^™ Delivery System (DCB00 (Z311063P Rev. D)).
2. Data on File, Johnson & Johnson Surgical Vision, Inc. 2018.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^™ 1-PIECE IOL WITH THE TECNIS SIMPLICITY^™ DELIVERY SYSTEM
Rx Only

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

INDICATIONS
The TECNIS SIMPLICITY^™ Delivery System is used to fold and assist in inserting the TECNIS 1-Piece intraocular lens 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
This is a single use device, do not re-sterilize the lens or the TECNIS SIMPLICITY^™ Delivery System. 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 TECNIS SIMPLICITY^™ 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 (BSS) or viscoelastics is required when using the TECNIS SIMPLICITY^™ Delivery System. For optimal performance when using OVD, use the HEALON^™ family of viscoelastics. The use of Balanced Salt Solution with additives has not been studied for this product. Do not use if the TECNIS SIMPLICITY^™ Delivery System has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the TECNIS SIMPLICITY^™ Delivery System and/or the lens may have been compromised. When the insertion system is used improperly, the haptics of the TECNIS 1-piece lens may become damaged.

WARNINGS
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis. 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 defect 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. Children under the age of 2 years are not suitable candidates for intraocular lenses. Do not attempt to disassemble, modify or alter the TECNIS SIMPLICITY^™ 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 of the TECNIS SIMPLICITY^™ Delivery System is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the TECNIS SIMPLICITY^™ Delivery System. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge. The lens and TECNIS SIMPLICITY^™ 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. 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 TECNIS SIMPLICITY^™ Delivery System minimizes the risk of infection and/ or inflammation associated with contamination. The reuse / re-sterilization / 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. The TECNIS^™ 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the TECNIS SIMPLICITY^™ Delivery System.

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).

PP2023CT5085