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LenSx® Laser +

LenSx® Laser

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.

View Important Product Information for
INFINITI® Vision System +

INFINITI® Vision System

Caution:
Federal law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected.

Indication:
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

  • Ultrasound with UltraChopper® Tip achieves the functionality of cataract separation.
  • AquaLase® Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells.
  • The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of INFINITI® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.

When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications:
Use of the NeoSoniX®, OZil® torsional, U/S, or AquaLase® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

Attention:
Refer to the directions for use for a complete listing of indications, warnings and precautions.

INFINITI® Vision System

Caution:
Federal law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected.

Indication:
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

  • Ultrasound with UltraChopper® Tip achieves the functionality of cataract separation.
  • AquaLase® Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells.
  • The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of INFINITI® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.

When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications:
Use of the NeoSoniX®, OZil® torsional, U/S, or AquaLase® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

Attention:
Refer to the directions for use for a complete listing of indications, warnings and precautions.

LenSx® Laser

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.