This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems
PMA Applicant: AMO Manufacturing USA, LLC
Address: 510 Cottonwood Dr., Milpitas, CA 95035
Approval Date: September 9, 2019
Approval Letter: Approval Order
What is it? This approval expands the indications for use of the iDesign Refractive Studio (iDesign) and STAR S4 IR Excimer Laser System (Laser System) to wavefront-guided photorefractive keratectomy (PRK) to reduce or eliminate nearsightedness (myopia) with or without astigmatism (a refractive error in which the eye focuses light rays more strongly in one direction than another).
How does it work? The systems are used for photorefractive keratectomy (PRK), a type of surgery used to correct vision by reshaping the top surface of the cornea using a laser. Before the laser treatment, the doctor uses iDESIGN Refractive Studio to measure the patient’s eye and determine how the cornea should be re-shaped to improve the vision. The STAR S4 IR® Excimer Laser can produce rapid pulses that remove small and precise amounts of corneal tissue. The doctor then uses the laser to re-shape the cornea as determined by iDESIGN® Refractive Studio. The treatment is guided by the treatment plan from iDESIGN® Refractive Studio, including the wavefront measurements.
When is it used? The systems are used to treat up to -8.00 units of focusing power (diopters or D) of nearsightedness and up to -3.00 D of astigmatism (eye shaped more like a football than a basketball), as measured by iDESIGN® Refractive Studio System in the treated eye. The standard clinical refraction and the iDesign refraction must agree to within 0.625 D for myopia and 0.5 D for astigmatism.
Patients must be 18 years of age or older with stable refractions (a change of no more than 1.0 D in myopia during the 12 months prior to surgery) and iDesign pupil measurements of at least 4 millimeters.
What will it accomplish? iDESIGN System-driven PRK treatments are intended to correct nearsightedness with or without astigmatism and help patients see distant objects better without glasses or contact lenses.
When should it not be used? The systems should not be used on patients who:
- Have any type of active connective tissue disease (e.g., rheumatoid arthritis), or active autoimmune disease (e.g., lupus).
- Have significant dry eye. Severe eye dryness may delay healing or interfere with the surface of the eye after surgery.
- Show signs of keratoconus (an eye disorder in which there is thinning and distortion of the cornea, which results in blurred or distorted images) or other corneal shape abnormalities.
- Have uncontrolled diabetes.
- Have an active eye infection or inflammation of the eye, recent herpes eye infections or problems from past infections of the eye.
- Have corneas too thin for safe treatment.
Additional information (including warnings, precautions, and adverse events: