PUREPOINT® LASER IMPORTANT PRODUCT INFORMATION
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Indications for Use: The PUREPOINT® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulatison, 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.
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.
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.
- 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.
ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.