MAR 2020

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/1215009

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Not an actual patient. EyeWorld PP2019CT4510 Learn more at TecnisIOL.com INDICATIONS: The TECNIS Symfony 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 e… ects 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 e… ects 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 signifi cant 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 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. Indications and Important Safety Information Rx Only TECNIS SYMFONY EXTENDED RANGE OF VISION IOL 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 phacoemulsifi cation and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefi t 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 fi eld 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 a… ect 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 benefi ts 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 fi rst and second eyes in the ZLB00 group. TECNIS MULTIFOCAL FAMILY OF 1-PIECE IOLs REFERENCE: 1. DOF2018CT4021. Johnson & Johnson Surgical Vision, Inc; 2018. TECNIS and TECNIS Symfony are trademarks of Johnson & Johnson Surgical Vision, Inc. ©Johnson & Johnson Surgical Vision, Inc. 2019 | TecnisIOL.com | PP2019CT4510 | July 2019 See the Passion in Each Patient TECNIS Personalized Vision refers to combining a TECNIS Symfony IOL in one eye and a TECNIS Multifocal IOL in the fellow eye. Seamless clarity from near to far. 1 Because his passion is on the line. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. TECNIS +3.25 D +

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