IMPORTANT SAFETY INFORMATION

Indication:

LASIK (laser-assisted in situ keratomileusis) is a laser surgery procedure that permanently changes the shape of the cornea to reduce or eliminate nearsightedness, farsightedness, or mixed visual irregularities due to an abnormal curve in the cornea (astigmatism). Only an eye care professional trained in laser vision correction can determine if you are a candidate for this procedure. The iFS® laser is a surgical laser that can be used to create flaps for use in LASIK surgery.

Contraindications:

You should not have LASIK if you have collagen vascular (such as rheumatoid arthritis), autoimmune, or an immunodeficiency disease because they affect the body's ability to heal. You should not have this procedure if you are pregnant or nursing, show signs of corneal thinning, or take medications with eye-related side effects, such as Isotretinoin (Accutane®) for acne treatment or Amiodarone hydrochloride (Cordarone®) for normalizing heart rhythm.

Warnings:

LASIK is not recommended if you have diabetes, a history of herpes simplex or herpes zoster keratitis, significant dry eye, or severe allergies.

Precautions:

Your doctor will examine your eyes to determine if you are a candidate for this procedure. Talk to your doctor about any eye-related conditions, injuries, or surgeries you have had, as well as any changes to your vision in the past year. These may result in poor vision after LASIK. Tell your doctor about any medications you are taking. After surgery, you may find it more difficult to see in conditions such as dim light, rain, snow, fog, or glare from bright lights at night. LASIK is for patients 21 years of age and over.

Side effects:

Please consult with your eye care professional and carefully review the Patient Information Booklet regarding the potential risks and benefits of this procedure. Results may vary for each individual patient.

The iLASIK^® platform utilizes the STAR S4 IR^® Excimer Laser System, WaveScan WaveFront^® System, as well as the iFS^® Advanced Femtosecond Laser during the LASIK procedure.

Caution:

U.S. Federal Law restricts these devices to use by practitioners who have been trained in their calibration and operation, and who have experience in the surgical treatment and management of refractive errors.

For U.S. Consumers Only

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio Wavefront-Guided LASIK & Monovision LASIK Treatments

INDICATIONS:

The STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio refraction as follows: Spherical equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.50 D; Cylinder Axis: If either the manifest cylinder entered into the iDESIGN® Refractive Studio or the iDESIGN® Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15º (0.5 D) to 7.5º (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio System/iDESIGN®Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with mixed astigmatism as measured by iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with myopia as measured by iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D; 18 years of age or older, and with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).

CONTRAINDICATIONS:

Wavefront-guided LASIK surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK. In patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane®) for acne treatment or Amiodarone hydrochloride (Cordarone®) for normalizing heart rhythm.

WARNINGS AND PRECAUTIONS:

Wavefront-guided LASIK is not recommended in patients who have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency rub their eyes often; have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect); are taking the medication Isotretinoin (Accutane®); are taking antimetabolites for any medical conditions. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions.

CAUTION:

ADVERSE EVENTS:

Prior clinical study of monovision LASIK using the WaveScan WaveFront® System aberrometer, supports the safety and effectiveness of iDESIGN® driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Wavefront-guided Monovision in Presbyopic Patients with Low to Moderate Myopia and Wavefront-guided Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio for Wavefront-Guided Photorefractive Keratectomy (PRK)

INDICATIONS:

The STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: with myopia, with or without astigmatism, as measured by iDESIGN® Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D, with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio System refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less than or equal to 0.5 D, in patients 18 years of age or older; with refractive stability (a change of ≤1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and with wavefront capture diameter of at least 4 mm.

CONTRAINDICATIONS:

iDESIGN® System driven PRK surgery is contraindicated in patients with any type of active connective tissue disease or autoimmune disease, in patients with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with uncontrolled diabetes, in patients with active eye infection or active inflammation, in patients with recent herpes eye infection or problems resulting from past infection, in patients with significant dry eyes. If the patients have severely dry eyes, PRK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing or interfere with the surface of the eye after surgery. It may result in poor vision after PRK.

WARNINGS AND PRECAUTIONS:

iDESIGN® System driven PRK surgery is not recommended in patients have systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or controlled diabetes, have an immunocompromised status or take medications that may result in a weakened immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin (Accutane®), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, In patients with a cardiac pacemaker, implanted defibrillator or other implanted electronic device, have mild to moderate dry eye, have decreased vision in one eye (e.g., amblyopia). Surgeons are reminded that they should instruct the patient to fixate on the Patient Fixation LED during surgery with or without the use of the ActiveTrak System. Please refer to Operator’s Manual for a list of additional Precautions.

CAUTION:

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 practitioner who has been trained in the calibration and operation of this device. ADVERSE EVENTS: Please refer to Operator’s Manual for a list of Adverse Events and Complications in clinical studies for wavefront-guided PRK Patients with Myopia and Myopic Astigmatism.

CONTRAINDICATIONS:

iDESIGN® System driven PRK surgery is contraindicated in patients with any type of active connective tissue disease or autoimmune disease, in patients with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with uncontrolled diabetes, in patients with active eye infection or active inflammation, in patients with recent herpes eye infection or problems resulting from past infection, in patients with significant dry eyes. If the patients have severely dry eyes, PRK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing or interfere with the surface of the eye after surgery. It may result in poor vision after PRK.

WARNINGS AND PRECAUTIONS:

iDESIGN® System driven PRK surgery is not recommended in patients have systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or controlled diabetes, have an immunocompromised status or take medications that may result in a weakened immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin (Accutane), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, In patients with a cardiac pacemaker, implanted defibrillator or other implanted electronic device, have mild to moderate dry eye, have decreased vision in one eye (e.g., amblyopia). Surgeons are reminded that they should instruct the patient to fixate on the Patient Fixation LED during surgery with or without the use of the ActiveTrak System. Please refer to Operator’s Manual for a list of additional Precautions.

CAUTION:

ADVERSE EVENTS:

Please refer to Operator’s Manual for a list of Adverse Events and Complications in clinical studies for wavefront-guided PRK Patients with Myopia and Myopic Astigmatism.

IMPORTANT SAFETY INFORMATION for the IFS® FEMTOSECOND LASER

INDICATIONS:

CONTRAINDICATIONS:

You should not have LASIK if you have collagen vascular, autoimmune, or immunodeficiency diseases, are pregnant or nursing, if you have corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, or symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with advanced glaucoma, in patients with uncontrolled diabetes. Lamellar resection for the creation of a corneal flap using the iFS® laser is contraindicated for the following conditions; corneal edema, corneal lesions, hypotony, glaucoma, existing corneal implant and keratoconus.

WARNINGS:

LASIK is not recommended if you have systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or controlled diabetes, have an immunocompromised status or take medications that may result in a weakened immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin (Accutane), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, have a cardiac pacemaker, implanted defibrillator or other implanted electronic device, have mild to moderate dry eye, have decreased vision in one eye (e.g., amblyopia).

PRECAUTIONS:

SIDE EFFECTS:

Possible side effects include dryness, which may be severe; loss of vision or the possible need for glasses or contact lenses after surgery; and visual disturbances such as halos (hazy rings around lights), glare, starbursts, double images, and other visual irregularities that may be debilitating. Possible complications resulting from LASIK flap creation include swelling, inflammation or pain in your eye, infection, or flap-related complications. Mild to severe light sensitivity occurred in 1% of patients between 2 and 6 weeks after surgery. Some patients (0.03%) noticed a temporary spoke-like band of light in their peripheral vision. Please consult with your eye care professional and carefully review the Patient Information Booklet regarding the potential risks and benefits of this procedure. Results may vary for each individual patient. The iLASIK® Technology Suite consists of the iDESIGN® System or WaveScan® System, iFS® or IntraLase® FS Femtosecond Laser, and the STAR S4 IR® Excimer Laser.