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SUMMARY OF IMPORTANT SAFETY INFORMATION

Rx Only

FOR THE iFS® FEMTOSECOND LASER
INDICATIONS

The IntraLase® FS and iFS® Lasers are precision ophthalmic surgical lasers indicated for use in patients undergoing surgery or treatment requiring initial lamellar resection of the cornea and to create tunnels for placement of corneal ring segments, in lamellar keratoplasty and corneal harvesting, in the creation of a corneal flap in patients undergoing LASIK surgery, and in the creation of a lamellar cut / resection of the cornea for lamellar keratoplasty(IntraLase-Enabled Keratoplasty or IEK), and in the creation of a penetrating cut/incision for penetrating keratoplasty (or IEK). The iFS Laser is also indicated for use in penetrating and/or intrastromal arcuate incisions, and for patients undergoing ophthalmic surgery or other 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, descemetocoele 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. 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 professional. The product may contain mercury. Please dispose accordingly to state, local or federal laws.

See Full Indications and Important Safety Information.

FOR THE STAR S4 IR® EXCIMER LASER SYSTEM AND iDESIGN® ADVANCED WAVESCAN STUDIO SYSTEM
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.

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 iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and 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 in patients with: collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, symptoms of significant dry eyes, corneal thickness would cause anticipated treatment to violate the posterior 250 microns (μm) of corneal stroma, 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 a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, 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; 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 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.
 

See Full Indications and Important Safety Information for the iDESIGN® System  and STAR S4 IR® Excimer Laser System.

PP2018MLT4018