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The iDESIGN® Refractive Studio

FOOTNOTES

*Compared to the Hartmann-Shack sensor in the WaveScan WaveFront® System.

**Results seen using the STAR S4 IR® Excimer Laser.

†System dimensions are only for the optical head and do not include the motorized table.

REFERENCES

1. Food and Drug Administration (FDA). Premarket approval P9300016 S044, S045 and S048.

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR® LASER, THE iDESIGN® REFRACTIVE STUDIO AND THE iDESIGN® ADVANCED WAVESCAN STUDIO SYSTEM

Indications for Use

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 15° (0.5 D) to 7.5° (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 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). 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 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 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). 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 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). STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront® System.The STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism from -6.00 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.50D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of hyperopia and hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.

Conventional LASIK procedure using the STAR S4 IR® Excimer Laser System

Laser assisted in situ keratomileusis (LASIK) procedure using the STAR S4 IR® Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -14.0 D with or without refractive astigmatism from 0.5 to 5.0D*; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. In patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.

Conventional PRK procedure using the STAR S4 IR® Excimer Laser System

Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR® Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -6.0 D spherical equivalent at the corneal plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -12.0 D spherical myopia at the spectacle plane with no more than 4.0 D of refractive astigmatism1; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +1.0 and +6.0 D sphere at the spectacle plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.

Contraindications

Laser refractive 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

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.

Precautions:

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

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 Monovision in Presbyopic Patients with Low to Moderate Myopia and Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

LASIK label
Rx Only

1 Caution must be used to calculate treatment in MINUS CYLINDER at the spectacle plane (vertex distance 12.5 mm) before entering the refraction into the laser in order to conform with the Indications for Use.

PP2018MLT4177