TECNIS® Personalized Vision refers to combining a TECNIS SymfonyTM IOL in one eye and a TECNIS® Multifocal IOL in the fellow eye.
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Read to Learn More About Physicians' Experiences with TECNIS® Personalized Vision.
Authors: Eric Donnenfeld, MD, Keith Walter, MD, Margan Farid, MD
Original insert published in the June 2019 issue of Cataract and Refractive Surgery Today.
Authors: Keith Walter, MD, Daniel Chang, MD
Original insert published in the July 2019 issue of Cataract and Refractive Surgery Today.
1. Black S. A Clinical Assessment of Visual Performance of Combining the TECNIS Symfony Extended Range of Vision IOL (ZXR00) with the +3.25 D TECNIS Multifocal 1- piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction. J. Clinical Ophthalmology. 2018. 2129-2136
2. de Medeiros A. Comparison of Visual Outcomes After Bilateral Implantation Of A Diffractive Trifocal Intraocular Lens And Blended Implantation Of An Extended Depth Of Focus Intraocular Lens With A Diffractive Bifocal Intraocular Lens. J. Clinical Ophthalmology. 2017. 1911 - 1961
Indications and Important Safety Information
TECNIS SYMFONYTM EXTENDED RANGE OF VISION IOL
INDICATIONS: The TECNIS SymfonyTM Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing 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 ZXR00 IOL is intended for capsular bag placement only. WARNINGS: 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. SERIOUS ADVERSE EVENTS: The most frequently reported serious adverse events that occurred during the clinical trial of the TECNIS SymfonyTM 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.
TECNIS® MULTIFOCAL FAMILY OF 1-PIECE IOLs
INDICATIONS: The TECNIS® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectaclei ndependence. The intraocular lenses are intended to be placed in the capsular bag. 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. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. PRECAUTIONS: Prior to surgery, 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. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. ADVERSE EVENTS: The rates of surgical re-interventions, most of which were non-lens related, were statistically higher than the FDA grid rate for the ZLB00 (+3.25 D) lens model. The re-intervention rate was 3.3% for both the first and second eyes in the ZLB00 group.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
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