Important Safety Information

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iDESIGN®

Contraindications

You should not have LASIK if you have collagen vascular (e.g., rheumatoid arthritis), autoimmune (e.g., lupus), or immunodeficiency diseases (e.g., AIDS) because they affect the body’s ability to heal. You should not have this procedure if you are pregnant or nursing; show signs of corneal abnormalities or corneal thinning; have symptoms of significant dry eyes; advanced glaucoma; and uncontrolled diabetes. If you have severely dry eyes, LASIK may increase the dryness, may delay healing after surgery, may or may not go away and it may result in poor vision after LASIK.

Warnings and Precautions

LASIK is not recommended if you have cataracts, corneal scars, or dry eye syndrome; glaucoma; diabetes; severe allergies; history of Herpes simplex or Herpes zoster keratitis; are taking Isotretinoin (Accutane®), Sumatriptan (Imitrex®), Amiodarone hydrochloride (Cordarone®) or antimetabolites for any medical conditions; history of crossed eyes; previous corneal, intraocular surgery, LASIK or refractive surgery; family history of degenerative corneal disease; and history of inflammation of the eye. Your doctor will examine your eyes to determine if you are a candidate for this procedure. Talk to your doctor about any eye-related conditions, injuries, or surgeries you have had, any medications you are taking, and any changes to your vision in the past year. After surgery, you may find it more difficult to see in conditions such as dim light, rain, snow, fog, or glare from bright lights at night. Future measurements of your eye pressure or future cataract surgery can be affected by this procedure. Tell your future doctor you’ve had Advanced CustomVue LASIK surgery.

Risks

As with any surgical procedure, there are risks associated with Advanced CustomVue LASIK treatments. It is important to discuss these risks with your doctor before you make any decision to have the surgery. If the results of the surgery are not satisfactory, your doctor may want to perform additional laser treatment in either one or both eyes. Talk to your doctor about what is best for you. Some risks are related to the creation of the corneal flap. Corneal flap complications include but are not limited to: cutting an incomplete, irregular flap or free flap; misalignment of the flap; and perforation of the cornea. Corneal flap complications range in severity from those that simply require the treatment to be postponed for several months, to those which create corneal irregularities resulting in permanently blurred vision. You may need reading glasses even if you did not wear them before. Your vision may not be perfect, and you may need to wear glasses or contact lenses for some activities even after laser vision correction.

Side Effects

Possible side effects include loss of vision and visual disturbances such as double vision, sensitivity to bright lights, increased difficulty with night vision, fluctuations in vision, and other visual irregularities that may be debilitating. Please consult with your eye care professional and carefully review the Patient Information Booklet regarding the potential risks and benefits of this procedure. Results may vary for each individual patient.

Reference:
1. FDA approval P930016/S044, S045, S048. The National Eye Institute-Refractive Error Quality of Life instrument (NEI-RQL-42) was administered to subjects at the periodic study exams.2. Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of Wavefront-guided Laser in situ Keratomileusis Using a New-Generation Hartmann-Shack Aberrometer in Patients with High Myopia. J Cataract Refract Surg 2015; 41:1810–1819*Compared to the WaveScan WaveFront® System.
3. Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Wavefront-guided Photorefractive Keratectomy with the Use of a New Hartmann-Shack Aberrometer in Patients with Myopia and Compound Myopic Astigmatism. J. of Ophth, volume 2015.4. Schallhorn SC, Brown M, Venter JA, Teenan D, Hettinger KA, Yamamoto H. Early Clinical Outcomes of Wavefront-Guided Myopic LASIK Treatments Using a New- Generation Hartmann-Shack Aberrometer. J Refract Surg. 2014;30(1):14-21.

*A phoropter is used for vision correction and measures errors in 0.25 diopter increments. iDESIGN® system wavefront measurements are in 0.01 diopter increments, making it 25x more accurate. These precise corrections are applied to the right spots on the cornea according to correction needed.

iDESIGN® System with STAR S4 IR® Laser 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.

Indications

The STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System is indicated for wavefront-guided LASIK in patients with myopia as measured by the iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder, in patients with hyperopia as measured by the iDESIGN® System up to +4.0 D SE, with up to +2.00 D cylinder, and in patients with mixed astigmatism where the magnitude of the cylinder (1.0 D to 5.0 D) is greater than the magnitude of the sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and the iDESIGN® System refraction of

1) SE: magnitude of the difference is ˂ 0.625 D, and 2) cylinder: magnitude of the difference is ≤ 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of ≤ 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).

Contraindications

Laser refractive surgery is contraindicated for: patients with collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, patients with signs of corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, patients with symptoms of significant dry eyes, patients whose corneal thickness would cause the anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, and in patients with advanced glaucoma, and uncontrolled diabetes. 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.

Warnings and Precautions

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. The safety and effectiveness of this laser for LASIK correction have NOT been established in patients: with progressive refractive errors, ocular disease, corneal abnormality, previous corneal or intraocular surgery, or trauma in the ablation zone, who are taking the medication Sumatriptan (Imitrex®), or Amiodarone hydrochloride (Cordarone®), with corneal neovascularization within 1.0 mm of the ablation zone, over the long term (more than 1 year after surgery for myopia and more than 2 years for mixed astigmatism), for patients who engage in activities that could endanger or damage the LASIK flap, for patients who have a family history of degenerative corneal disease, history of inflammation of the eye, for patients who have a history of crossed eyes (strabismus) or who have undergone strabismus surgery, prior LASIK or Refractive Surgery, with history of any eye diseases or abnormalities such as corneal scars or active disease, and whose BSCVA is worse than 20/20. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. 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.

Adverse Events

Possible adverse events include loss of best spectacle-corrected visual acuity (BSCVA), serious Transient Light Sensitivity Syndrome, serious primary open-angle glaucoma, miscreated flap, melting of the flap, severe glare, and severe dry eyes. Complications can include corneal edema, epithelial ingrowth, diffuse lamellar keratitis, foreign body sensation, and pain.

©2017 AMO Manufacturing USA, LLC. iLASIK, Advanced CustomVue, STAR S4 IR, iDESIGN, and iDESIGN Advanced WaveScan Studio are trademarks owned
by or licensed to AMO Manufacturing USA, LLC. All other trademarks are the intellectual property of their respective owners.PP2017RF0200