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What is Blade-Free

How Does it Work

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Important Safety
Information

• Experience Blade-Free LASIK with the IntraLase Method

  The IntraLase Method is a 100% blade-free approach to creating your LASIK flap – the thin flap of tissue that the doctor folds back in order to perform your LASIK procedure. The IntraLase Method can only be performed using the IntraLase FS or iFS laser.

  

  Over 5 million procedures have been performed using the IntraLase Method. And, in a clinical survey of LASIK patients who had their corneal flaps created using a microkeratomes in one eye and the IntraLase Method in the other, patients preferred the vision in the IntraLase-treated eye 3:1 over the microkeratomes among those who stated a preference.¹
  
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  1. Mahdavi S. IntraLase: Coming of age. Cataract Refract Surg today. October 2005:117-120.

• What is Blade-Free?

  Traditionally, LASIK doctors have used an instrument called a microkeratome for the creation of LASIK flaps. The microkeratome is a hand-held blade that moves across the eye, cutting the LASIK flap as it goes. LASIK is extremely safe, but if complications do occur, the microkeratome is frequently the cause. The IntraLase Method, by contrast, is a 100% blade-free approach to corneal flap creation - enabling your doctor to create an individualized LASIK flap without a blade ever touching your eye.

  

  Blade-Free Advantages

  • Doctor and Patient Confidence: Over 5 million procedures have been performed safely and effectively using the IntraLase Method. And, in a clinical survey of LASIK patients who had their corneal flaps created using a microkeratome in one eye and the IntraLase Method in the other, patients preferred the vision in the IntraLase treated eye 3:1 over the microkeratomes among those who stated a preference.¹
  • Truly Customized: The IntraLase Method enables your doctor to tailor the LASIK flap according to the shape of your eye. Everything from the diameter of your flap to the angle of its edges can be precisely determined. This is important because everyone’s eyes are shaped a little differently, and having a corneal flap that’s individualized to your eye will help your doctor ensure that you get the best possible results.
  • Better Outcomes: Clinical studies show excellent visual outcomes and high patient satisfaction when the IntraLase Method is used.^{2, 3}
  
  
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  1. Mahdavi S. IntraLase: Coming of age. Cataract Refract Surg today. October 2005:117-120.

  2. Donnenfeld E. Preservation of corneal innervations with femtosecond laser inverted sidecut flaps. Invest Ophthalmol Vis Sci. 2010 51: EAbstract 2855.

  3. Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided laser in-situ keratomileusis: prospective contralateral eye study. J Cataract Refract Surg. 2005;31(1): 120-126.

• How Does it Work?

  The creation of the corneal flap prepares the eye for the second step of the LASIK procedure, when another laser, known as an excimer laser, is used to correct vision.

  Unlike other procedures, the IntraLase Method creates the corneal flap by applying tiny, rapid pulses of laser light – not a metal blade (microkeratome). Each pulse of light passes through the top layers of your cornea and forms a microscopic bubble at a specific depth and position within your eye that is determined by the doctor. As the IntraLase or iFS Laser moves back and forth across your eye, a uniform layer of bubbles forms just below the corneal surface. Your doctor creates your corneal flap by gently separating the tissue where these bubbles have formed.

  Because of the way in which the IntraLase Method creates a precisely positioned layer of bubbles just beneath the surface of your eye, it creates a smooth, even surface after your flap is lifted. The flap is then folded back so the doctor can perform the second step of your LASIK procedure.

  The IntraLase Method flap creation process takes less than 15 seconds per eye. Including preparation time, the entire LASIK procedure typically takes about 10 minutes. Once the entire procedure is completed, the corneal flap “locks” back into position.

  
  
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• Find an IntraLase Doctor

  Leading doctors from around the world believe in the IntraLase Method. Find a trained and certified physician near where you live or work. And to ensure that you get a 100% blade-free LASIK experience, remember to ask for the IntraLase Method by name.

• Important Safety Information

  Indications for Use

  The IntraLase FS and iFS Lasers are 21 CFR 1040 class IIIb ophthalmic surgical lasers with the following indications for use:

  • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
  • In patients undergoing ophthalmic surgery or other treatment requiring Arcuate cuts/incisions in the cornea, penetrating and/or
    Intrastromal
  • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for
    placement of corneal ring segments
  • In lamellar keratoplasty and corneal harvesting
  • In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of
    the cornea
  • In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and for the creation of a penetrating
    cut/incision for penetrating keratoplasty.

  The IntraLase FS and iFS Laser delivery systems are used in conjunction with a sterile disposable IntraLase Patient Interface,
  consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation lenses, intended for single-use.

  The IntraLase FS and iFS Lasers should only be operated by, or under the direct supervision of a trained physician with certification in
  laser safety and in the use of the IntraLase FS Laser.

  Flap Contraindications

  Lamellar resection for the creation of a corneal flap using the IntraLase FS or iFS Lasers is contraindicated if any of the following
  conditions exist. Potential contraindications are not limited to those included in this list:

  • Corneal edema
  • Corneal lesions
  • Hypotony
  • Glaucoma
  • Existing corneal implant
  • Keratoconus

  IntraLase Enabled Keratoplasty (IEK) Contraindications

  Contraindications to use of the IntraLase FS or iFS Lasers for the indications described for the IEK procedure include:

  • Any corneal opacity adequately dense to obscure visualization of the iris;
  • Descemetocoele with impending corneal rupture;
  • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and
  • Corneal thickness requirements that are beyond the range of the system.

  The following conditions should also be considered when using the IntraLase FS or iFS Lasers for IEK:

  • Severe corneal thinning
  • Subjects with pre-existing glaucoma
  • A history of steroid responsive rise in intraocular pressure
  • Preoperative intraocular pressure greater than 21 mmHg in the operative eye

  Important Safety Information

  • Subjects with more than 1200 μm corneal thickness at the 9 mm peripheral zone
  • Active intraocular inflammation
  • Active ocular infection

  Warnings

  FS and iFS Lasers

  • The performance of surgical or laser alignment procedures, operation of controls or any other adjustments other than those
    specified herein may result in hazardous conditions for both patients and personnel.
  • While the risk of fire is extremely low, the IntraLase FS or iFS Laser should not be operated in the presence of flammable
    anesthetics, volatile substances, or oxygen flow lines.
  • Only certified accessories that conform to National and International standards (i.e., IEC 60950-1, IEC 60601-1 or similar)
    should be connected to the input/output ports on the FS Laser.
  • High voltage electrical circuits are accessible if the console panels are removed. Only trained AMO service representatives
    should attempt to open the console panels. Serious injury or death may occur as a result of exposure to electrical circuits in
    the unit interior.
  • Do not use cell phones, pagers, or radio frequency devices of any kind in the same room as the IntraLase FS or iFS Laser.
  • If an articulating chair is used in conjunction with the FS or iFS Laser system, take proper precautions to avoid any unintended
    movement of the chair toward the laser system. Refer to the specific operating instructions provided by the manufacturer of the
    articulating chair.
  • To ensure the proper operation of the Z-Verifier safety features, use the joystick to applanate and to activate the green eye
    contact LED. Do not lift and place the objective on the eye in lieu of using the joystick.
  • The suction ring assembly must be disengaged from the patient's cornea before using the Home button.
  • Check all treatment parameters for accuracy.
  • Only trained AMO service representatives should perform unpacking, installation, and servicing of the IntraLase FS or iFS
    Lasers. Covers must not be removed by anyone other than AMO service representatives. Accidental contact with the high
    voltage electrical circuits in the interior of the IntraLase FS or iFS Laser consoles may result in serious injury or death.
  • Ocular exposure to collimated beams contained in the console interior can produce retinal damage.
  • The UPS (Uninterruptable Power Supply) is designed for exclusive use with the FS or iFS Laser system. Do not connect any
    other electrical device to the UPS system.
  • Check all parameters for accuracy before proceeding to the next phase.
  • Patient procedures performed with an improperly operating IntraLase FS or iFS Laser may produce poor or otherwise
    unacceptable resections, or may result in complications.
  • Use of this laser system allows laser surgical incisions to be created up to 1200 μm deep. Additionally, resection patterns can
    be freely adjusted to create various geometric shapes. It is advised that the user check all treatment parameters, and then
    verify the pattern outline in the graphical display, before proceeding to the next phase.
  • Setting the posterior depth too deep during could result in injury to other intraocular structures.
  • Operation of this system, with the keratoplasty application, requires that the user provide a calibrated corneal thickness
    measurement device.
  • Caution must be taken to remove suction prior to removing applanation to avoid injury to intraocular structures.

  Patient Interface

  • The Patient Interface disposables should not be reused or re-sterilized.
  • Used IntraLase Patient Interface assemblies should be treated as medical waste. Use and disposal of the IntraLase Patient
    Interface is detailed in the IntraLase Patient Interface Directions for Use (DFU).
  • The applanation lens becomes etched by the laser during the side-cut procedure and MUST NOT be re-used. Laser light will
    not effectively permeate an etched lens, and the precision of the laser will be altered.
  • To preserve sterility, open the disposable tray while wearing sterile, powder free surgical gloves and complete the following
    steps.
  • Do not attempt to use a damaged Patient Interface.
  • If the suction ring assembly clip fails to disengage, or if it prematurely disengages, do not attempt use.

  Flap Complications

  Possible complications resulting from Lasik surgery include (potential complications are not limited to those included in this list):

  • Corneal edema
  • Corneal pain
  • Epithelial ingrowth
  • Epithelial defect
  • Infection
  • Flap de-centration
  • Incomplete flap creation
  • Flap tearing or incomplete lift-off
  • Free cap
  • Photophobia
  • Corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates, and iritis
  • Thin or thick flaps
  • Flap striae

  The following sporadically reported visual symptoms may occur following LASIK flap creation with the IntraLase FS or iFS Laser.

  Transient Light Sensitivity Syndrome (TLSS)
  Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and
  six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of
  this sensitivity is observed in approximately 1% of patients who undergo flap creation with the IntraLase FS laser. Patients respond to
  the use of hourly topical steroids such as Pred Forte, and most report improvement within one week of treatment.

  Peripheral Light Spectrum (PLS)
  Peripheral Light Spectrum (PLS) is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in
  the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive
  effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate
  postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is
  clinically inconsequential for the vast majority of patients.

  US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care
  practitioner.quiring initial lamellar resection of the cornea

  • In patients undergoing ophthalmic surgery or other treatment requiring Arcuate cuts/incisions in the cornea, penetrating and/or
    Intrastromal
  • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for
    placement of corneal ring segments
  • In lamellar keratoplasty and corneal harvesting
  • In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of
    the cornea
  • In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and for the creation of a penetrating
    cut/incision for penetrating keratoplasty.

  The IntraLase FS and iFS Laser delivery systems are used in conjunction with a sterile disposable IntraLase Patient Interface,
  consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation lenses, intended for single-use.

  The IntraLase FS and iFS Lasers should only be operated by, or under the direct supervision of a trained physician with certification in
  laser safety and in the use of the IntraLase FS Laser.

  Flap Contraindications

  Lamellar resection for the creation of a corneal flap using the IntraLase FS or iFS Lasers is contraindicated if any of the following
  conditions exist. Potential contraindications are not limited to those included in this list:

  • Corneal edema
  • Corneal lesions
  • Hypotony
  • Glaucoma
  • Existing corneal implant
  • Keratoconus

  IntraLase Enabled Keratoplasty (IEK) Contraindications

  Contraindications to use of the IntraLase FS or iFS Lasers for the indications described for the IEK procedure include:

  • Any corneal opacity adequately dense to obscure visualization of the iris;
  • Descemetocoele with impending corneal rupture;
  • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and
  • Corneal thickness requirements that are beyond the range of the system.

  The following conditions should also be considered when using the IntraLase FS or iFS Lasers for IEK:

  • Severe corneal thinning
  • Subjects with pre-existing glaucoma
  • A history of steroid responsive rise in intraocular pressure
  • Preoperative intraocular pressure greater than 21 mmHg in the operative eye

  Important Safety Information

  • Subjects with more than 1200 μm corneal thickness at the 9 mm peripheral zone
  • Active intraocular inflammation
  • Active ocular infection

  Warnings

  FS and iFS Lasers

  • The performance of surgical or laser alignment procedures, operation of controls or any other adjustments other than those
    specified herein may result in hazardous conditions for both patients and personnel.
  • While the risk of fire is extremely low, the IntraLase FS or iFS Laser should not be operated in the presence of flammable
    anesthetics, volatile substances, or oxygen flow lines.
  • Only certified accessories that conform to National and International standards (i.e., IEC 60950-1, IEC 60601-1 or similar)
    should be connected to the input/output ports on the FS Laser.
  • High voltage electrical circuits are accessible if the console panels are removed. Only trained AMO service representatives
    should attempt to open the console panels. Serious injury or death may occur as a result of exposure to electrical circuits in
    the unit interior.
  • Do not use cell phones, pagers, or radio frequency devices of any kind in the same room as the IntraLase FS or iFS Laser.
  • If an articulating chair is used in conjunction with the FS or iFS Laser system, take proper precautions to avoid any unintended
    movement of the chair toward the laser system. Refer to the specific operating instructions provided by the manufacturer of the
    articulating chair.
  • To ensure the proper operation of the Z-Verifier safety features, use the joystick to applanate and to activate the green eye
    contact LED. Do not lift and place the objective on the eye in lieu of using the joystick.
  • The suction ring assembly must be disengaged from the patient's cornea before using the Home button.
  • Check all treatment parameters for accuracy.
  • Only trained AMO service representatives should perform unpacking, installation, and servicing of the IntraLase FS or iFS
    Lasers. Covers must not be removed by anyone other than AMO service representatives. Accidental contact with the high
    voltage electrical circuits in the interior of the IntraLase FS or iFS Laser consoles may result in serious injury or death.
  • Ocular exposure to collimated beams contained in the console interior can produce retinal damage.
  • The UPS (Uninterruptable Power Supply) is designed for exclusive use with the FS or iFS Laser system. Do not connect any
    other electrical device to the UPS system.
  • Check all parameters for accuracy before proceeding to the next phase.
  • Patient procedures performed with an improperly operating IntraLase FS or iFS Laser may produce poor or otherwise
    unacceptable resections, or may result in complications.
  • Use of this laser system allows laser surgical incisions to be created up to 1200 μm deep. Additionally, resection patterns can
    be freely adjusted to create various geometric shapes. It is advised that the user check all treatment parameters, and then
    verify the pattern outline in the graphical display, before proceeding to the next phase.
  • Setting the posterior depth too deep during could result in injury to other intraocular structures.
  • Operation of this system, with the keratoplasty application, requires that the user provide a calibrated corneal thickness
    measurement device.
  • Caution must be taken to remove suction prior to removing applanation to avoid injury to intraocular structures.
    

  Patient Interface

  • The Patient Interface disposables should not be reused or re-sterilized.
  • Used IntraLase Patient Interface assemblies should be treated as medical waste. Use and disposal of the IntraLase Patient
    Interface is detailed in the IntraLase Patient Interface Directions for Use (DFU).
  • The applanation lens becomes etched by the laser during the side-cut procedure and MUST NOT be re-used. Laser light will
    not effectively permeate an etched lens, and the precision of the laser will be altered.
  • To preserve sterility, open the disposable tray while wearing sterile, powder free surgical gloves and complete the following
    steps.
  • Do not attempt to use a damaged Patient Interface.
  • If the suction ring assembly clip fails to disengage, or if it prematurely disengages, do not attempt use.

  Flap Complications

  Possible complications resulting from Lasik surgery include (potential complications are not limited to those included in this list):

  • Corneal edema
  • Corneal pain
  • Epithelial ingrowth
  • Epithelial defect
  • Infection
  • Flap de-centration
  • Incomplete flap creation
  • Flap tearing or incomplete lift-off
  • Free cap
  • Photophobia
  • Corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates, and iritis
  • Thin or thick flaps
  • Flap striae

  The following sporadically reported visual symptoms may occur following LASIK flap creation with the IntraLase FS or iFS Laser.

  Transient Light Sensitivity Syndrome (TLSS)
  Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and
  six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of
  this sensitivity is observed in approximately 1% of patients who undergo flap creation with the IntraLase FS laser. Patients respond to
  the use of hourly topical steroids such as Pred Forte, and most report improvement within one week of treatment.

  Peripheral Light Spectrum (PLS)
  Peripheral Light Spectrum (PLS) is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in
  the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive
  effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate
  postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is
  clinically inconsequential for the vast majority of patients.

  US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care
  practitioner.

Summary of Important Safety Information:

The IntraLase FS and iFS Laser Systems are ophthalmic surgical lasers indicated for use in patients undergoing surgery or treatment requiring the initial lamellar resection of the cornea, in the creation of a lamellar cut / resection of the cornea for lamellar IntraLase-Enabled Keratoplasty (IEK), in the creation of a penetrating cut/incision for penetrating IEK, penetrating and intrastromal arcuate incisions (iFS Laser Only) and for corneal harvesting. Initial lamellar resection contraindications may include cornea edema, glaucoma, and keratoconus. Initial lamellar resection risks and complications may include corneal pain, flap tearing, and epithelial ingrowth. IEK contraindications may include any corneal opacity adequately dense to obscure visualization of this iris, descemetocoele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, and cornea thickness requirements that are beyond the range of the system. Patients are requested to consult with their eye care professional for a complete listing of the contraindications and risks. U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care professional.