VISION
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EXPLORE

When used in concert, the market-leading systems that power the iLASIK® Suite create a personalized, patient-centric treatment process. As one of the most trusted names in laser vision correction, our refractive portfolio gives your patients the freedom to see brilliantly without glasses or contacts.


THE IFS® ADVANCED FEMTOSECOND LASER

Rooted in precision and performance, the iFS® Laser delivers tailored LASIK flaps and customized incisions across multiple ophthalmic subspecialties.

  • LASIK flaps
  • Keratoplasty incisions
  • Intracorneal ring segments
  • Arcuate incisions
  • Clear corneal and paracentesis incisions
  • Corneal pockets

THE IDESIGN® SYSTEM

Built on the foundation of proven wavefront-guided technology, the iDESIGN®System is the guiding force behind every iLASIK® Technology Suite treatment.

The advanced, high-definition sensor provides exceptional imaging clarity with 5x higher resolution and 3x the dynamic range when compared to the prior WaveScan WaveFront® System. With its advanced capture capabilities, it takes up to five measurements in a single sequence.

  • Wavefront aberrometry
  • Wavefront refraction
  • Corneal topography
  • Keratometry
  • Pupillometry

STAR S4 IR® EXCIMER LASER

The STAR S4 IR® Excimer Laser provides pinpoint ablation accuracy 100% personalized to your patients’ visual needs through proprietary and market-leading technology.

  • Iris Registration
  • Variable Repetition Rate
  • Variable Spot Scanning
  • ActiveTrak Automatic Centering
  • ActiveTrak 3D Eye Tracking

When guided by the iDESIGN® System, the STAR S4 IR® Excimer Laser provides outstanding visual outcomes and high patient satisfaction.

  • 99% of patients were not limited in active sports or outdoor activities1
  • 99% experienced little to no difficulty with changes in the clarity of their vision1
  • 97% were satisfied with their vision correction overall1
  • 93% stated they had no difficulty driving at night2
  • Approximately 90% of eyes had improvements or no negative impact to their contrast sensitivity across all lighting conditions2
  • A majority of participants achieved 20/16 or better visual acuity1

COMMITTED TO YOUR SUCCESS

We are dedicated to helping you take your refractive business to the next level. We provide extensive online and in-person education — from practice-building tools and patient marketing initiatives to surgical and field service support.

My partnership with Abbott Vision is a relationship based on trust and on the knowledge that they will work extraordinarily hard, just as hard as I will, to achieve excellent patient outcomes.”
—ERIC DONNENFELD, MD

COMMITTED TO INNOVATION

The iLASIK® Suite helps you deliver precise, predictable outcomes for your refractive patients.

PROVEN EXPERTISE

With more than 25 years of industry leadership and over 18 million* procedures performed, the iLASIK® Suite can help you meet the needs of your patients today and tomorrow.

TOTAL PRACTICE SUPPORT

Get comprehensive support from the team at Abbott Vision to help grow your practice through innovative marketing initiatives.


FOOTNOTES

*Procedures done on Abbott Vision femtosecond and excimer lasers.

REFERENCES

  1. Clinical studies submitted to FDA via P930016 supplement 044.
  2. FDA Summary of Safety and Effectiveness Data (SSED) for the STAR S4 IR® Excimer Laser: P930016/S044. May 6, 2015.

INDICATIONS AND IMPORTANT SAFETY INFORMATION 

FOR THE iFS® ADVANCED FEMTOSECOND LASER
INDICATIONS

The iFS® femtosecond laser is an ophthalmic surgical laser indicated for use in patients undergoing surgery or treatment requiring initial lamellar resection of the cornea, in treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, in treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal, In lamellar IEK and corneal harvesting; in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the corneal, in the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK, in treatment requiring the creation of corneal channels for placement/insertion of a corneal inlay device. 

CONTRAINDICATIONS

Lamellar resection for the creation of a corneal flap is contraindicated in the presence of corneal edema, corneal lesions, hypotony, glaucoma, existing corneal implant, or keratoconus.  IEK procedures and arcuate incisions are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, or corneal thickness requirements that are beyond the range of the system. Creation of corneal channels for placement/insertion of a corneal inlay device are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, corneal thickness requirements that are beyond the range of the system, any previous incisional refractive corneal procedure, e.g. radial keratotomy, significant corneal neovascularization in the limbal area for a planned incision, previous history of corneal Herpes Simplex Keratitis, previous corneal transplant, any cataract, corneal edema, corneal lesions, hypotony, existing corneal implant, keratoconus or subjects with severe corneal thinning less than 450 microns. 

PRECAUTIONS

A high level of surgical skill is required for these lasers. A surgeon should have successfully completed one or more training courses before attempting to create a corneal resection. The use of the iFS® Laser for IEK procedures or for arcuate incisions is not recommended for patients with severe corneal thinning, preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus.  The use of the iFS® laser for creation of corneal channels for placement of a corneal inlay device is not recommended for patients with preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus.

ADVERSE EVENTS

Possible complications resulting from LASIK flap creation include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia, flap decentration, incomplete flap creation, flap tearing or incomplete lift-off, free cap, inflammation (e.g., diffuse lamellar keratitis, corneal infiltrates, or iritis), thin or thick flaps, or flap striae.  Transient light sensitivity syndrome (TLSS) and peripheral light spectrum (PLS) have been sporadically reported and may occur following LASIK flap creation. TLSS is characterized by symptoms of mild to severe light sensitivity that manifests between 2 and 6 weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity is observed in approximately 1% of patients who undergo flap creation with either laser. Patients respond to the use of hourly topical steroids and most report improvement within 1 week of treatment. PLS is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however, the potential diffractive effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within 3 months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.  Arcuate incision complications include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia or corneal endothelium perforation.  Creation of corneal channel for placement of a corneal inlay device complications include corneal edema, corneal pain, epithelial ingrowth, epithelial defect, infection, implant de-centration, incomplete inlay channel creation, corneal tearing or incomplete inlay channel dissection, photophobia, corneal inflammation, such as diffuse lamellar keratisis (DLK), corneal infiltrates, and iritis, and inlay channel bleeding.

WARNINGS

Check all treatment parameters for accuracy. The posterior depth should be programmed at least 125 microns above the corneal endothelium. Use of these laser systems allows laser surgical incisions up to 1200 µm deep. Setting the posterior depth too deep could result in injury to other ocular structures. Use caution when setting cut position and cut angle to avoid overlapping arcuate incisions. The applanation lens becomes etched by the laser during the side-cut procedures and must not be reused. Laser light will not effectively permeate an etched lens, and the precision of the laser will be altered. Patient interface disposables should not be reused or resterilized.

CAUTION

U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device.

iFS® Femtosecond Laser System Warning Label
 
FOR STAR S4 IR® LASER AND iDESIGN® ADVANCED WAVESCAN STUDIO SYSTEM
INDICATIONS FOR USE

The STAR S4 IR® Excimer Laser and iDESIGN® Advanced WaveScan Studio (iDESIGN®System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with myopia as measured by iDESIGN® System 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® System 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 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.   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. 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.  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. 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. Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR® 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 astigmatism; 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. Phototherapeutic Keratectomy (PTK) procedures using the STAR S4 IR® System are primarily indicated for subjects with decreased best corrected visual acuity and/or with disabling pain that is the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The subjects must have failed alternative treatment options. For safety, the immediate post- operative corneal thickness must not be less than 250 μm. 

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. The Phototherapeutic Keratectomy procedure should not be performed if the post-operative thickness would be less than 250 μm (excluding the epithelium and Bowman’s membrane), or if a deep scar is present that is not contained in the anterior one-third of the cornea.

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 immune compromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency to 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; lower uncorrected visual acuity may be anticipated in the PRK treatment of higher degrees of myopia with and without astigmatism (>-5.0 D MRSE). Hyperopic shift has been a major safety issue following PTK. It is advisable to ablate only to a depth that is necessary to improve vision and/or relieve symptoms, and not to attempt to remove all scar tissue. Aggressive attempts to ablate all visible scar tissue risk hyperopic shift and corneal ectasia. Subjects should be informed concerning the possibility of hyperopia and subsequent possible induced anisometropia. Reactivation of herpes simplex keratitis has occurred after PTK. A course of oral acyclovir is recommended if there is a history of herpetic infection. If topical steroids are used post-operatively, subjects must be monitored for possible steroid side-effects, such as ocular hypertension and/or glaucoma with subsequent damage to the optic nerve, or development of posterior subcapsular cataract. Subjects with systemic disease likely to affect wound healing, such as connective tissue disease, diabetes, severe atopic disease, or an immunocompromised status should be approached cautiously, as the safety and effectiveness of the excimer system has not been established in patients with these conditions.

PRECAUTIONS

General: Preoperative pachymetry measurement must be performed. To reduce the risk corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated.  There is no safety and effectiveness for any Laser Vision Correction procedure in patients with progressive refractive errors, ocular disease, corneal abnormality, previous corneal or intraocular surgery, trauma in the ablation zone, residual corneal thickness less than 250 microns at the completion of ablation. There is no safety and effectiveness information for patients that are taking the medication Sumatriptan (Imitrex®) and Amiodarone hydrochloride (Cordarone®). Advanced CustomVue LASIK (using iDESIGN® System): The treatment of highly myopic eyes necessitates the removal of significant amounts of corneal tissue. The iDESIGN® System calculates the estimated residual bed depth using the pachymetry and intended flap thickness entered by the user. Actual flap thicknesses may vary. If the estimated residual stromal bed is ≤ 320 microns, an in-the-bed pachymetric measurement should be performed. The safety and effectiveness of the iDESIGN® System have not been established for wavefront-guided LASIK surgery in patients with corneal neovascularization within 1.0mm of the ablation zone, over the long term (more than 1 year after surgery), or with prior intraocular or corneal surgery of any kind, whose BSCVA is worse than 20/20, whose wavefront measurement diameter is <4mm, for patients who engage in activities that could endanger or damage the LASIK flap. CustomVue LASIK (using WaveScan WaveFront® System): There is no safety and effectiveness information for CustomVue LASIK (using WaveScan WaveFront® System) for more than 1 year after surgery, for prior intraocular or corneal surgery of any kind, or for retreatment. Conventional LASIK (Manifest Refraction): There is no safety and effectiveness information for the patients who have had prior incisional refractive surgery, for patients with hyperopic astigmatism, for more than 6 months after LASIK surgery for myopia with or without astigmatism, hyperopia with or without astigmatism, or mixed astigmatism. PRK: There is no safety and effectiveness information for PRK refractive treatments over the long term, more than 3 years after PRK surgery for low myopia; more than 1 year after PRK surgery for high myopia with astigmatism or for hyperopia with or without astigmatism, patients with a history of keloid formation, patients taking hormone replacement therapy or antihistamines who may have delayed re-epithelialization of the cornea following surgery, PRK retreatment of hyperopic astigmatism. Of the eyes treated in the PRK trials, only 21/200 (10.5%) of highly myopic eyes had myopia between -10.0 and -12.0 diopters and only 13/275 (4.7%) of hyperopic eyes had hyperopia between +4.0 and +6.0 diopters. These populations were not sufficient to determine the level of effectiveness or the complication rates for this refractive error range with the same reliability as for eyes with less severe refractive errors. PTK: The safety and effectiveness of the STAR S4 IR® System has not been established in treatment of recurrent corneal erosions, treatment of corneal disease in eyes with recurrent or active ocular disease such as iritis, uveitis, keratitis sicca, and severe blepharitis, treatment of scars and irregularities in patients with keratoconus, patients with corneal neovascularization near the ablation zone, patients with systemic disease likely to affect wound healing, patients with previous corneal surgery, pregnant women, or patients under 18 years of age. 

ATTENTION

Reference the Operator’s Manual for a complete listing of Indications and Important Safety Information.

CAUTION
U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner. CAUTION

U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

ATTENTION

Reference the Operator’s Manual for a complete listing of Indications and Important Safety Information.

 
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