TECNIS^™ Toric II IOL

FOOTNOTES
a Keratometric cylinder
b Surgically induced Astigmatism
^ Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24 and Holladay, J.T. International Intraocular Lens & Implant registry 2003. J Cataract Refract Surg. 2003; 29:176-197.
* Based on average pseudophakic human eye and ‘Holladay et al. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24’.
‡ Derived from clinical evaluation results of the 1-Piece IOL Platform for optical biometry.
§ A-Constant theoretically derived for ultrasound biometry.

REFERENCES
1. Data on File. Johnson & Johnson Surgical Vision, Inc. 2013. [REF2014OTH0002]
2. Data on File. Johnson & Johnson Surgical Vision, Inc. 2019.
3. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013;4(8):1294-1304.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS^™ TORIC II 1-PIECE IOL
Rx Only

INDICATIONS
The TECNIS Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS
Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or  uveitis; 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); a compromised eye due to previous trauma or developmental defects in which appropriate  support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in  whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates  for intraocular lenses. The clinical study for the TECNIS Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal  astigmatism of < 1.0 diopter. The TECNIS Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS Toric 1-Piece IOL 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.

PRECAUTIONS
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. Do not soak or rinse with any solution other than sterile balanced salt solution or sterile normal saline. Do not store in  direct sunlight or at greater than 113°F. 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 Toric 1-Piece IOL with the intended axis of placement. When the insertion system is used improperly, the haptics of the TECNIS Toric 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. 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 clinicalstudy and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator  (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been  substantiated in patients with certain preexisting ocular conditions, and intraoperative complications. 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. Pre-existing conditions include: 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, or irregular corneal  astigmatism. Intraoperative conditions include: excessive vitreous loss, capsulotomy by any technique other than a circular tear, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques  other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow  eye, peripheral retinal pathology, etc.), capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. All  preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. 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 IOL multi-center clinical study. The PCA algorithm forthe selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS Toric intraocular lens labeling. Please  refer to the Johnson & Johnson Surgical Vision Toric Calculator user manual for more information. Variability in any of the preoperative measurements can influence  patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS
Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, pupillary block, retinal detachment, IOL dislocation, persistent corneal stromal edema, persistent cystoid macular edema, or secondary surgical intervention (including implant repositioning, removal, or other surgical procedure). The most frequently reported cumulative adverse event that occurred during the TECNIS^® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE UNFOLDER^™ PLATINUM 1 SERIES IMPLANTATION SYSTEM
Rx Only

INDICATIONS
The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting JJSV Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag.

CONTRAINDICATIONS
Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS
The UNFOLDER Platinum 1 Series Implantation System should be used ONLY with JJSV Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube.

See Full Indications and Important Safety Information

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

PP2023CT5070