LenSx® Laser Important Product Information
- Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.
Cataract Surgery Indication:Cataract Surgery 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)
- History of lens or zonular instability
- Any contraindication to cataract or keratoplasty
- This device is not intended for use in pediatric surgery.
*Glaucoma is not a contraindication when these procedures are performed using the LenSx® Laser SoftFit® Patient Interface Accessory
Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.
- Alcon Data on File.
- Alcon Data on File, 2022.
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- Bouchet, C et al. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis. Value in Health. 2017;20(9):A800–A801.
- Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. J Cataract Refract Surg. 2017;43:16 –21.
- Roberts T V, et al. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Clin Ophthalmol. 2016;10:2021–2029.
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- Alcon Data on File, 2022
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- Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. PLoS One. 2016;11(3):e0152088.
- Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. J Cataract Refract Surg. 2016;42:1470–1476.
- Chen X, et al. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. J Cataract Refract Surg. 2017;43:486–491.
- Yeu E, et al. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA.