Canada: Important Safety Information

INDICATIONS and IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY™ TORIC II OPTIBLUE™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELs DFW100, DFW150, DFW225, DFW300 AND DFW375, in Canada

INDICATIONS FOR USE
The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ Toric II OptiBlue™ 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, a reduction of residual refractive cylinder and reduced spectacle dependence across a range of distances.

PRECAUTIONS
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. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration of the intraocular lens. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. The intraocular pressure of implanted patients with glaucoma should be carefully monitored for postoperative changes.

WARNINGS
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZFW implantation. The patients should be informed of the possibility of visual effects (such as halo or glare) in nighttime or poor visibility conditions. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZFW implantation since they may not fully benefit in terms of potential spectacle independence. 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. The lens model ZFW may affect image quality and lead to some reduction of contrast sensitivity compared to a monofocal lens. Therefore, patients should exercise caution when driving at night or in poor visibility conditions.

Rotation of toric lens model ZFW 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. Carefully remove all viscoelastic from the capsular bag. Residual viscoelastic may allow the lens to rotate, causing misalignment of the toric lens model ZFW with the intended axis of placement.

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 explantation.

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

INDICATIONS and IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY™ OPTIBLUE™ WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DFR00V, IN CANADA

INDICATIONS FOR USE
The TECNIS SimplicityTM Delivery System is used to fold and assist in inserting the TECNIS SynergyTM OptiBlueTM 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 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.

PRECAUTIONS

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. Prior to implanting, examine the lens package for proper lens model, dioptric power, and expiration date. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve centration of the intraocular lens. When the insertion system is used improperly, the haptics of the IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. The intraocular pressure of implanted patients with glaucoma should be carefully monitored for postoperative changes.

WARNINGS
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. The lens model ZFR00V should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Well-informed patients with well-defined visual needs and preferences should be selected for lens model ZFR00V implantation. The patients should 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 astigmatism greater than 1.0 diopter may not be suitable candidates for lens model ZFR00V implantation since they may not fully benefit in terms of potential spectacle independence. The lens model ZFR00V may affect image quality and lead to some reduction of contrast sensitivity compared to a monofocal lens. Therefore, patients should exercise caution when driving at night or in poor visibility conditions.

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

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance™ and TECNIS Eyhance™ Toric II IOLs 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 Eyhance™ IOL which is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provides similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance™ Toric II IOL, which is indicated 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 by extracapsular cataract extraction and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision compared to a non-toric IOL. The lens also extends the depth of focus, which improves vision for intermediate tasks, and provides similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.

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. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. 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 implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes.

PRECAUTIONS
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 (BSS) 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
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.

PP2021AVT4052