* Value theoretically derived for a typical 22.0 D lens. AMO recommends that surgeons personalize their A-constant based on their surgical techniques and equipment, experience with the lens model and postoperative results.
- TECNIS Symfony® Extended Range of Vision IOLs DFU. Santa Ana, Calif. Abbott Medical Optics Inc.
- Data on File, Abbott Medical Optics Inc., 2016.
- Data on File, Abbott Medical Optics Inc., 2013.
- Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS. 2010 Dec;36(12):2056-60.
- Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013 Jul 11;4(8):1294-304.
- 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. JCRS. 1988;14(1):17-24).
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS SYMFONY® TORIC EXTENDED RANGE OF VISION IOL
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.
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. 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: patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, 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, 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, congenital bilateral cataracts, previous history of, or a predisposition to, retinal detachment, patients with only one good eye with potentially good vision, medically uncontrollable glaucoma, corneal endothelial dystrophy or proliferative diabetic retinopathy. The TECNIS Symfony® IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus. The TECNIS Symfony® IOL may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. The physician should carefully weigh the potential risks and benefits for each patient, and should fully inform the patient of the potential for reduced contrast sensitivity before implanting the lens in patients. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease which may cause present or future reduction in acuity or contrast sensitivity. Because the TECNIS Symfony® IOL may cause a reduction in contrast sensitivity compared to a monofocal IOL, patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions. Some visual effects associated with the TECNIS Symfony® IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for implantation with the TECNIS Symfony® and TECNIS Symfony® Toric IOLs, models ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism. The effectiveness of TECNIS Symfony® Toric IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. Rotation of TECNIS Symfony® Toric IOLs away from their intended axis can reduce their 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. AMO IOLs are single-use devices only. Do not reuse this IOL.
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. When performing refraction in patients implanted with the TECNIS Symfony® IOL, interpret results with caution when 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 TECNIS Symfony® IOL optical design. 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. Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature > 113°F (45°C). Do not autoclave the intraocular lens. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions. When the insertion system is used improperly, TECNIS Symfony® IOLs may not be delivered properly (i.e., haptics may be broken). Please refer to the specific instructions for use provided with the insertion instrument or system. The safety and effectiveness of TECNIS Symfony® IOLs have not been substantiated in patients with preexisting ocular conditions and intraoperative complications (see below for examples). 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: [before surgery] pupil abnormalities, prior corneal refractive or intraocular surgery, 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, irregular corneal astigmatism, amblyopia, macular disease, pregnancy, [during surgery] excessive vitreous loss, non-circular capsulotomy/capsulorhexis, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. 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. The use of methods other than the TECNIS Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the parent TECNIS® Toric IOL U.S. IDE study 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 for the TECNIS Symfony® Toric IOL. All preoperative surgical parameters are important when choosing a TECNIS Symfony® Toric IOL for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. 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 parent TECNIS® Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study for the parent TECNIS® Toric IOL. Note that the TECNIS Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Potential adverse effects (e.g., complications) associated with the use of the device include the following: infection (endophthalmitis), hypopyon, IOL dislocation, cystoid macular edema, corneal edema, pupillary block, iritis, retinal detachment/tear, raised IOP requiring treatment, visual symptoms requiring lens removal, tilt and decentration requiring repositioning, residual refractive error resulting in secondary intervention. Secondary surgical interventions include, but are not limited to: lens repositioning (due to decentration, rotation, subluxation, etc.), lens replacement, vitreous aspirations or iridectomy for pupillary block, wound leak repair, retinal detachment repair, corneal transplant, lens replacement due to refractive error, unacceptable optical/visual symptoms, severe inflammation.
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%). One eye was reported with pupillary capture and the eye that had endophthalmitis also had a small hypopyon. No other serious adverse events and no lens-related adverse events occurred during the trial.
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.