Alcon Retina

Game-changing Technology for Vitreoretinal Surgery

As the worldwide leader in ophthalmic surgical products, Alcon occupies the premier position in surgical suites across the globe and manufactures and markets products for all ocular surgical procedures. Alcon has continued to build its position as the worldwide leader in pharmaceuticals for the eye by continuing to advance treatments for eye infections, allergies, and diseases such as glaucoma. At the same time, Alcon has also expanded research into relatively unknown areas such as macular degeneration, diabetic retinopathy, and other sight-threatening conditions.
By developing tools that give eye surgeons greater control during procedures, Alcon is dedicated to the vitreoretinal market. Through new innovations, Alcon is partnering with surgeons to help patients see the world more clearly.
h2> CONSTELLATION ® Vision System

Surgical Management of Difficult Cases Supplement
Supplement discussing reduced complications in diabetic retinal detachments, managing retained lens material, removal of IOL from vitreous cavity, and combined surgery for retinal pathology and cataract. Retinal Physician . Nov/Dec 2011 Issue.

Advancing MIVS Trends for Vitreoretinal Surgery in Complex Cases Supplement
Supplement discussing MIVS for proliferative vitreoretinopathy, IOP control, vitreoretinal dissection techniques for diabetic retinal detachment, sutureless vitrectomy for complications of proliferative diabetic retinopathy, combined 23G surgery, and MIVS for tractional retinal detachment in PDR. Retina Today . Nov/Dec 2011 Issue.

New Technique for Tissue Separation by Pravin U. Dugel, MD
Proportional reflux hydrodissection aids surgeon in traction retinal detachment procedures.

Direct PFO-Silicone Oil Exchange by Maria H. Berrocal, MD
This new maneuver improves surgeon control of the intraocular environment and reduces the risk of retinal slippage.

As Delicate as it Gets by Robert Morris, MD, Ferenc Kuhn, MD, PhD, and Mathew Sapp, MD
Releasing traction on the cystic fovea in vitreomacular traction syndrome.

Surgical Maneuvers with Microincisional Vitrectomy Surgery Supplement
Supplement discussing efficiency in vitreoretinal surgery, preventing 23G wound leaks, study of the standard 25G vitrectomy system vs new ultra-high-speed vitrectomy system, and improvements in instrumentation for MIVS. Retina Today . Sept 2010 Issue.

Expanding the Scope of MIVS by Carl Claes, MD
Substantial improvements in technology have increased the capabilities of surgeons and the indications for small-incision surgery.

Wound Construction and Incision Advancements in Micro-incision Vitrectomy
y Peter K. Kaiser, MD
Article discussing MIVS benefits and disadvantages including the risk of wound leakage, hypotony, and endophthalmitis.

Reusables vs. Disposables: A Safe Conclusion for DSPs by Sunil Gupta, MD, Alan Franklin, MD, PhD, and John P. Myers, MD
A brief return to reusable instruments convinced these surgeons of the importance of weighing intangible variables as well as costs. Read about the factors that influenced their return to disposable instrumentation.

CONSTELLATION ® Vision System with PUREPOINT ® Laser

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.
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. Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections. Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard. Vitreous traction has been known to create retinal tears and retinal detachments. The closed loop system of the CONSTELLATION ® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. 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 post operative 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.
Important Safety Information: Warnings and Cautions: A complete listing is available in the CONSTELLATION ® Vision System Operators 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.
h3> Alcon ® MIVS ™ Portfolio 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.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions:
Attach only ALCON ® supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient's intravenous connections. Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your ALCON ® sales representative for in-service information. Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids. Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye. Ensure proper placement of trocar cannulas to prevent sub-retinal infusion. Leaking sclerotomies may lead to post operative hypotony. Vitreous traction has been known to create retinal tears and retinal detachments. Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.
Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.
h3> GRIESHABER ® DSP Instrumentation 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.
GRIESHABER ® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER ® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions: CONSTELLATION ® Vision System
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. Attach only consumables supplied by Alcon to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections. Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard. Vitreous traction has been known to create retinal detachments. The closed loop system of the CONSTELLATION ® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. 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 post operative hypotony.
Warnings and Precautions: GRIESHABER ® DSP Instruments
Potential risk from reuse or reprocessing GRIESHABER ® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance. Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery. For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON ® illumination source. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized. Use appropriate pressure supply to ensure a stable IOP. If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument. Attention: Reference the device specific Directions for Use for a complete listing of indications, warnings, and precautions.
h3> GRIESHABER ® DSP Aspheric Macular Lens Indications for Use: The GRIESHABER ® DSP Aspheric Macular Lens is used to visualize the fundus and retinal structures during vitreoretinal surgery. It is designed as a self-retaining contact lens to allow hands-free operation.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions:
The device may be used only by well trained physicians and personnel. Potential risk from reuse or reprocessing include: reduced optical quality, surface damage on the optics, and foreign particle introduction to the eye. The surgeon’s team has to ensure that sufficient viscous fluid is available throughout usage of the lens for continuous humidification of the cornea.
Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.
h3> Vitreoretinal Laser Probes Indication: ALCON ® Laser probes are fiber optic probes indicated for use with an ALCON ® Laser System. Each package contains individually packaged sterile laser probes.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings and Precautions:
Do not use if package is damaged. Minimize the illuminator’s light intensity. Avoid operation of illuminated probes in air on consoles capable of illumination levels and settings higher than 10 lumens. This can result in fiber deformation and/or high surface temperatures.
Attention: Reference the Directions For Use for a complete listing of indications, warnings specific to the laser model.
h3> ALCON ® Lighted Instruments with ENGAUGE ® RFID Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Caution: This document is not intended to substitute for the necessity of reading and understanding the light source Operator’s Manual.
Indications and Usage: Fiber Optic Instruments with ENGAUGE ® Radio Frequency Identification Device (RFID) for use with the CONSTELLATION ® System. These instruments can be used on the ACCURUS ® System or ACCURUS ® High Brightness Illuminator (AHBI) using the RFID Adapter Model Number 8065751140.
Warnings and Precautions:
Minimize the light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. Avoid operation of a fiber in air on consoles capable of illumination levels and settings higher than 10 lumens. This may result in fiber probe deformation and/or high surface temperatures that may cause patient injury.
Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

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Alcon Retina

Game-changing Technology for Vitreoretinal Surgery

CONSTELLATION ® Vision System with PUREPOINT ® Laser