LENSX® LASER IMPORTANT PRODUCT INFORMATION
CAUTION: United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.
INDICATION: The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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.
RESTRICTIONS: Patients must be able to lie flat and motionless in a supine position. Patient must be able to understand and give an informed consent. Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP should use topical steroids only under close medical supervision.
CONTRAINDICATIONS: Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength. Descemetocele with impending corneal rupture. Presence of blood or other material in the anterior chamber. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only). Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape. Corneal thickness requirements that are beyond the range of the system. Corneal opacity that would interfere with the laser beam. Hypotony or the presence of a corneal implant. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease).
History of lens or zonular instability. Any contraindication to cataract or keratoplasty. This device is not intended for use in pediatric surgery.
WARNINGS: The LenSx® Laser System should only be operated by a physician trained in its use.
The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.
The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.
PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. Discard used Patient Interfaces as medical waste.
AES/COMPLICATIONS: Capsulotomy, phacofragmentation, or cut or incision decentration. Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure. Capsular tear. Corneal abrasion or defect. Pain. Infection. Bleeding. Damage to intraocular structures. Anterior chamber fluid leakage, anterior chamber collapse. Elevated pressure to the eye.
ATTENTION: Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.