INDICATIONS AND SAFETY INFORMATION | HOME


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Indications and Safety Information

Indications for Use

The VICTUS® Femtosecond Laser Platform is indicated for use for:

  • The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
  • For anterior capsulotomy during cataract surgery
  • The creations of cuts / incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea
  • Laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for posterior subcapsular (PSC) and cortical cataracts

Safety Information

The VICTUS® Femtosecond Laser Platform emits an invisible class 3B laser beam that may injure the retina of the eyes or burn the skin. Never look directly into the laser source.

Misuse of the laser system may lead to dangerous situations and severe injuries. See the Operator Manual for detailed directions, proper use, and full risk and safety information.

Contraindications
General contraindications for using the VICTUS® Femtosecond Laser Platform include, but are not limited to:

  • Pediatric surgery, hypotony, glaucoma, retinal disorders, rheumatic diseases, occlusion of retinal vessels, pellucid marginal degeneration, existing corneal implant, heavy vascularization of the ocular tissue, or epilepsy.
  • Conditions that would cause inadequate clearance between the intended capsulotomy cut and the corneal endothelium, such as chemosis, significant loss of stability of the conjunctiva, and nystagmus.
  • Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light, such as: residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated; ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated; a history of herpes zoster or herpes simplex keratitis; or subjects who are using ophthalmic medication(s) other than artificial tears for the treatment of ocular pathology including ocular allergy, or any corneal disease in the fellow eye that requires treatment (recurrent corneal erosion, severe basement membrane disease).
  • Patients who are pregnant or nursing, are blind in the fellow eye, or have a known sensitivity to planned concomitant medication.
  • Patients with a difference of more than 5D between minimum and maximum K-values of the central 3mm zone on a keratometric map of the cornea, maximum K-value of more than 60D, or minimum K-value of less than 37D.

General contraindications for using the VICTUS® Femtosecond Laser Platform to perform anterior capsulotomy include, but are not limited to

  • Patients with a poorly dilating pupil, anterior chamber depth (ACD) <1.5mm or ACD >4.8 mm as measured by ultrasonic examination, less than 40 years of age, previous corneal surgery of any kind, dry eye diseases, severe wound-healing disorders (such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, endocrine diseases, lupus, rheumatoid arthritis), diabetes mellitus, severe acne rosacea, or patients suffering from AIDS or HIV.

General contraindications for using the VICTUS® Femtosecond Laser Platform to perform lens fragmentation include, but are not limited to, the following:

  • Patients with a poorly dilating pupil, anterior chamber depth (ACD) <1.5mm or ACD >4.8 mm as measured by ultrasonic examination, history of lens or zonular instability, less than 40 years of age, posterior subcapsular (PSC) or cortical cataracts.

General contraindications for using the VICTUS® Femtosecond Laser Platform to perform corneal incisions include, but are not limited to, the following:

  • Dry eye diseases, previous corneal surgery, specifically 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.

General contraindications for using the VICTUS® Femtosecond Laser Platform to flaps for LASIK include, but are not limited to, the following:

  • Anyone who is not eligible for a laser vision correction (LVC), patient under the age of 18 years or legal age, previous corneal surgery of any kind, dry eye diseases, cataract, diabetes mellitus, severe wound-healing disorders (connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, endocrine diseases, lupus, rheumatoid arthritis, etc.), patients with an autoimmune disease, collagenosis, or clinically significant atopy, patients suffering from AIDS or HIV, or patients with signs of progressive or unstable myopia in the eye that require treatment.

Potential Complications

Potential general complications resulting from VICTUS® procedures include, but are not limited to the following:

  • Corneal abrasion or defect, pain, bleeding, inflammation, or elevated intraocular pressure.

Potential complications resulting from anterior capsulotomy or lens fragmentation include, but are not limited to the following:

  • Capsulotomy decentration, incomplete or interrupted capsulotomy or lens fragmentation, decentered intraocular lens (IOL), capsular tear, or damage to intraocular structures.

Potential complications resulting from the creation of corneal flaps or corneal cuts / incisions include, but are not limited to the following:

  • Corneal edema, epithelial ingrowth, flap or corneal cuts / incisions decentration, incomplete flap or corneal cuts / incisions creation
  • Flaps only: flap tearing or incomplete lift-off, free cap, photophobia, thick or thin flaps, flap striae

Misuse of the laser system may lead to dangerous situations and severe injuries. See the Operator Manual for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.