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Indications and Safety Information

CAUTION: United States Federal Law restricts this device to sale and use by or on the order of a licensed physician. INDICATIONS: The VICTUS Platform is indicated for use in 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 creation of cuts/incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts/incisions in the cornea, and for laser-assisted lens fragmentation during cataract surgery for nuclear cataracts, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts. Attention: Please refer to the Directions for Use for complete use instructions and safety. SUMMARY OF CONTRAINDICATIONS: Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. Patients who do not give informed consent, who are pregnant or nursing, have existing corneal implants, who have had any previous cornea surgery or pediatric patients. Conditions that interfere with intent to treat such as glaucoma, retinal disorders, rheumatic diseases, epilepsy, herpes zoster or herpes simplex keratitis, and heavy vascularization of ocular tissues. Conditions that interfere with proper docking such as chemosis, nystagmus, significant loss of stability of the conjunctiva, keratoconus, and corneal diseases requiring treatment. Conditions that may interfere with capsulotomy such as poorly dilating pupils, and anterior chamber depths (ACD) < 1.5 mm or ACD > 4.8 mm. Conditions that may interfere with creation of flap such as dry eye diseases, cataract, diabetes mellitus, severe acne rosacea, severe wound healing disorders, and immune deficiency diseases. Contraindicated for laser-assisted lens fragmentation of posterior subcapsular (PSC) and cortical cataracts.