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: 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® 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