Indication

The LENSAR Laser System – fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Laser Capsulotomy, laser phacofragmentation and/or corneal incisions surgery is contraindicated in patients: who are of pediatric age, whose pupils will not dilate or remain dilated to a diameter greater than that of the intended treatment and for capsulotomies and/or laser phacofragmentation with intended diameters of less than 4 mm or greater than 7 mm, who have existing corneal implants, who have previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, who have conditions that would cause inadequate clearance between the intended capsulotomy cut and the corneal endothelium, such as: hypotony, uncontrolled glaucoma, who have corneal disease or pathology that precludes transmission of light at the laser wavelength or causes distortion of laser light, such as: corneal opacities, residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated, ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated, a history of severe dry eye that has not responded to therapy, a history of herpes zoster or herpes simplex keratitis.

Potential contraindications are not limited to those included in the list.

WARNING: The safety and effectiveness of this laser have NOT been established in patients with diabetic retinopathy, a history of treated glaucoma, or prior intraocular surgery.

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50-00004-000 Rev. D 3/28/13