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: VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® Systems
PMA Applicant: AMO/VISX, Incorporated
Address: 3400 Central Expressway, Santa Clara, CA 95051-0703
Approval Date: July 11, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p930016s025a.pdf
What is it? These devices include a refractive excimer laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye according to the treatment plan; an eyetracker that detects the position of the eye and aligns the laser pulse with the cornea; a diagnostic wavefront sensor for the automated measurement, analysis, and recording of refractive errors of the eye; and an automated iris registration (IR™) system to rotate the treatment to align with the rotation of the eye under the laser.
How does it work? The laser system treats nearsightedness by removing tissue from the center of the cornea to flatten it and astigmatism by flattening the central cornea by different amounts and at different orientations to correct for uneven focus.
When is it used? The devices are intended for wavefront-guided LASIK (laser assisted in situ keratomileusis) treatment of patients 40 years of age or older to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes with myopic astigmatism up to -6.00 D MRSE, cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted eye. Patients should have a successful preoperative monovision trial or history of monovision experience and eyesight that has been stable (by ≤ 0.5 D) for the year prior to the pre-operative examination.
What will it accomplish? The goal of monovision treatment of presbyopia with the excimer laser is to allow patients to use one eye (dominant) for seeing far away and one eye (non-dominant) for seeing close up. Side effects may include glare from bright lights, halos (rings around lights), light sensitivity, night driving glare, and visual fluctuation. After monovision treatment, vision may not be perfect and patients may need to wear glasses or contact lenses for some activities, such as driving at night or reading small type.
When should it not be used? The system should not be used on patients who
- are pregnant or nursing;
- who have a collagen vascular, autoimmune or immunodeficiency disease;
- who show signs of keratoconus (an eye disorder in which there is thinning of the cornea which results in blurred or distorted images); or
- who are taking medications with ocular side effects (such as Accutane® or Cordarone®).
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p930016s025