(Información remitida por la empresa firmante)
Undesirable Side Effects/Adverse Effects: Possible complications resulting from this surgery include the following. Potential complications are not limited to those included in this list.Diffuse lamellar keratitis (DLK), Corneal edema, Corneal pain, Epithelial ingrowth, Epithelial defect, Infection, Corneal infiltrate/ulcer, Delayed healing, Corneal abrasion, Corneal erosion, Corneal haze, Corneal scar, Corneal scoring (Spoke-wheel like or striae), Inhomogeneous stromal bed, Eye pain/excessive tearing/eye redness, Inflammation of the episcleral, Iritis/Uveitis, Unexpected loss of corneal tissue, Corneal ectasia, Elevated IOP, Intraocular Hemorrhage, Subconjunctival hemorrhage, Venous and arterial blockage, Retinal vascular accidents, Ocular penetration, Cataract formation, Dysphotopsia, Blurry vision or halo/starburst/glare around lights at night, Ghost/ double images, Foreign body sensation or dry eye, Anisometropia, Ptosis, Vision correction regression, Anesthesia/drug reactions, De- centered lenticule, Incomplete lenticule creation, Lenticule tearing or inability to remove lenticule, Anterior corneal tear, Anterior corneal melt, Lenticule too deep or too shallow in the Cornea, Under or over refractive correction, Induced higher order aberrations, Transient light sensitivity syndrome, Peripheral light spectrum/rainbow glare
Vision Threatening Complications (these complications are uncommon, but possible followingrefractive surgery):
Perforation of the cornea, Retinal detachment, Partial or total loss of vision or eye.
Intended Patient: Adults 18 years old or older with refractive error.
NOTE: Pregnant or nursing women were not included in the clinical trials conducted.
0155-3005 Rev B_OUS EN FLAP
0155–3006 Rev B_OUS EN_SILK
SILK not yet approved for use in the U.S. This content is intended for Healthcare Professionals only, not for the general public.
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