INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION IOLs
INDICATIONS FOR USE
The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual 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 lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.
Patients with any of the conditions described in the Directions for Use 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. Lenses should not be placed in the ciliary sulcus. May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including: a perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions, may be significant enough that the patient may request removal of the IOL.
Rotation of the Tecnis Symfony Toric IOLs away from their intended axis can reduce their astigmatic correction, and misalignment ˃30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
Interpret results with caution when refracting 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 recommended. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the optical design. Target emmetropia for optimum visual performance. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.
Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or overinflation of the capsular bag may allow the lens to rotate, causing misalignment of the Tecnis Symfony Toric IOL with the intended axis of placement. For the Tecnis Symfony Toric IOL, variability in any preoperative surgical parameters (e.g. keratometric cylinder, incision location, surgeon’s estimated surgically induced astigmatism and biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case to prevent lens rotation.
SERIOUS ADVERSE EVENTS
The most frequently reported serious adverse events that occurred during the clinical trial of the Tecnis Symfony lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No lens-related adverse events occurred during the trial.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
INDICATIONS and IMPORTANT SAFETY INFORMATION for the TECNIS Toric 1-Piece IOL
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.
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. The clinical study did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one 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.
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. Refer to the TECNIS Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. 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. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave.
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).
Reference the Directions for Use labeling for a complete listing of Indications and Safety Information.
TECNIS Symfony and TECNIS are trademarks of Johnson & Johnson Surgical Vision, Inc.
© Johnson & Johnson Surgical Vision, Inc. 2018