This is a quick summary of information pertaining to FDA’s authorization to market this item. See below the Summary as well as product labelling for even more total details on this item, its indications for usage, as well as the basis for FDA’s authorization.
Item Call: iDESIGN ® Refractive Workshop and also CELEBRITY S4 IR ® Excimer Laser Systems
PMA Candidate: AMO Manufacturing UNITED STATES, LLC
Authorization Date: September 9, 2019
What is it?
This authorization broadens the indicators for use the iDesign Refractive Studio (iDesign) and also STAR S4 IR Excimer Laser System (Laser System) to wave front-guided photorefractive keratectomy (PRK) to lower or get rid of near sightedness that is called myopia or near-sightedness with or without astigmatism (a refractive error in which the eye focuses light rays a lot more highly in one direction)
Exactly how does it work?
The systems are made use of for photorefractive keratectomy (PRK), a sort of surgical treatment utilized to remedy vision by reshaping the leading surface area of the cornea making use of a laser. Before the laser treatment, the doctor uses iDESIGN Refractive Studio to measure the patient’s eye and also figure out just how the cornea ought to be re-shaped to boost the vision. The CELEBRITY S4 IR ® Excimer Laser can produce fast pulses that eliminate little and exact amounts of corneal cells. The physician after that makes use of the laser to re-shape the cornea as figured out by iDESIGN ® Refractive Workshop. The therapy is led by the treatment strategy from iDESIGN ® Refractive Studio, consisting of the wavefront measurements.
When is it made use of?
The systems are made use of to treat as much as -8.00 units of focusing power (dioptres or D) of near-sightedness and as much as -3.00 D of astigmatism (eye shaped a lot more like a football than a basketball), as measured by iDESIGN ® Refractive Workshop System in the concerned eye. The basic medical refraction and also the iDesign refraction must come to within 0.625 D or dioptres for near-sightedness and also 0.5 D or dioptres for astigmatism.
Patients need to be 18 years of age or older with stable refractions (a change of no more than 1.0 D or dioptres in myopia throughout the twelve month before surgical treatment) and also iDesign pupil measurements of a minimum of 4 millimetres.
What will it accomplish?
iDESIGN System-driven PRK treatments are planned to fix near-sightedness with or without astigmatism and also aid people see distant items much better without glasses or contact lenses.
When should it not be utilized? The systems must not be utilized on clients who:
– Have any kind of type of energetic connective cells condition (e.g., rheumatoid arthritis), or energetic autoimmune condition (e.g., lupus)
– Have significant dry eye. Extreme eye dryness might postpone recovery or hinder the surface of the eye after surgery
– Program indicators of keratoconus (an eye problem in which there is thinning and also distortion of the cornea, which results in blurred or misshaped images) or other corneal shape irregularities
– Have uncontrolled diabetes mellitus
– Have a vigorous eye infection or inflammation of the eye, current herpes eye infections or troubles from previous infections of the eye
– Have corneas that are too slim for risk-free therapy