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Vitreoretinal Surgery Has Changed Forever


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Vitreoretinal Surgery Has Changed Forever - 1

PANTONE Cool Gray 7 The CONSTELLATION® Vision System Indications for Use: The CONSTELLATION Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. ® The PUREPOINT ® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: • Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms. • Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma. • Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma. • And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions. BLACK Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Contraindications: Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments. Complications: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used. Warnings and Precautions: • The disposables used in conjunction with Alcon® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon® may affect system performance and create potential hazards. • ttach only Alcon ® supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient’s intravenous connections. A • ismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may M create a patient hazard. • Vitreous traction has been known to create retinal tears and retinal detachments. • he closed loop system of the CONSTELLATION ® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. T If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle. • Leaking sclerotomy may lead to postoperative hypotony. • Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm. • mportant Safety Information: Warnings and Cautions: A complete listing is available in the CONSTELLATION® Vision System Operators I Manual. To obtain a copy, please contact Alcon Customer Service. Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. To experience the game-changing performance of the CONSTELLATION® Vision System that surgeons are talking about, visit 1. Rizzo S, et al. Comparative study of the standard 25-gauge vitrectomy system vs the new ultra-high-speed vitrectomy system. Retina Today. September Insert, 2010. 2. Riemann C, et al. Prevention of intraoperative hypotony during vitreoretinal surgery: an instrument comparison. ASRS. Poster Presentation, 2010. 3. Nagpal M, et al. Comparison of clinical outcomes and wound dynamics of sclerotomy ports of 20, 25, and 23 gauge vitrectomy. Retina. 2009;29(2):225-231. 4. Davison J. Cumulative tip travel and implied followability of longitudinal and torsional phacoemulsification J Cataract Refract Surg. 2008;34:986-990. 5. Liu Y, et al. Torsional mode versus conventional ultrasound mode phacoemulsification. J Cataract Refract Surg. 2007;33:287-292. 6. Han Y, et al. Heat production: longitudinal versus torsional phacoemulsification. J Cataract Refract Surg. 2009;35:1799-1805.

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Vitreoretinal Surgery Has Changed Forever - 2

Vitreoretinal Surgery Has Changed Forever High Performance ULTRAVIT ® Probes OZil® Torsional Handpiece High speed ULTRAVIT® 5000 cpm probe with surgeon-controlled duty cycle reduces iatrogenic tears and post-op complications:1 Only the OZil® Torsional Handpiece delivers patented side-to-side oscillating ultrasonic movement. With virtually no repulsion, it is the new standard in followability and efficiency: • Allows surgeons to work closer to the retina with less traction • Dual pneumatic probe delivers efficient cutting up to 5,000 cpm and beyond • Enhanced versatility allows probe to be a...

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