The LenSx Laser® Difference

A New Class of Cataract Procedure

The LenSx^® Laser is Putting the Future in Motion. A technologically-advanced procedure, LenSx^® Laser Refractive Cataract Surgery offers a new level of precision and reproducibility in ophthalmic surgery. The additional steps performed by the LenSx^® Laser to align the capsular and corneal incisions in three dimensions are performed to optimize alignment of capsulotomy and corneal incisions.

Achieve Laser Accuracy

The LenSx^® Laser is designed to bring a new level of accuracy and reproducibility to refractive cataract surgery. Early proponents of the system report that, however accurate their manual procedures seemed in the past, they see measurable improvements when using the LenSx^® Laser¹.

A Platform for Precise Cataract Procedures

The precision of the LenSx^® Laser has been tested in a series of recent clinical studies. Zoltan Z. Nagy, MD of Semmelweis University in Budapest, evaluated the system's ability to perform anterior capsulotomies, lens fragmentation and create self-sealing corneal incisions¹.

Dr. Nagy demonstrated enhanced surgical accuracy and reproducibility:

All anterior capsulotomies created with the LenSx^® Laser achieved accurate centration and intended diameter, with no radial tears or adverse events seen.
Corneal incisions created with the LenSx^® Laser were highly reproducible, with precise dimensions and geometry.
In the same study, only 10% of manually created capsulorhexis achieved a similar diameter accuracy of +/-0.25 mm^1,2. These results can be seen in the diagram, below.

Diameter Accuracy of the LenSx^® Laser Versus Manual Capsulorhexis¹

Only 10% of manual capsulorhexis achieved diameter accuracy of +/- 0.25 mm.

Enhanced Reproducibility

The LenSx^® Laser can perform anterior capsulotomy, lens fragmentation and all corneal incisions with tremendous reproducibility. The system performs surgery according to your preferences, extending your expertise with laser precision. From clean three-plane corneal incisions to customized fragmentation patterns, you can create predictable cuts that carry through subsequent steps of refractive cataract surgery.

1. Nagy, ZZ. 1-year clinical experience with a new femtosecond laser for refractive cataract surgery. Paper presented at: Annual Meeting of the American Academy of Ophthalmology; October 24-27, 2009; San Francisco, CA.
2. Nagy, ZZ. Intraocular femtosecond laser applications in cataract surgery. Cataract & Refractive Surgery Today. September 2009:79-82.

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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.

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. United States Federal Law restricts the use of this device to practitioners who have been trained in the operation of this device.

Restrictions:

This device is not intended for use in pediatric surgery.
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, glaucoma, 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)
This device is not intended for use in pediatric surgery.

Attention:
Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

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

© 2012 Novartis, a global company based in Basel, Switzerland. The information and materials within this section pertain to the U.S. market only. Not all products are approved in every market, and approved labeling and instructions may vary by local country. See Alcon Privacy Policy and Terms & Conditions for the use of this Site.

Unless specifically noted, all comparisons herein relate to previous Alcon products and designs.

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