INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE VERISYSE® PHAKIC IOL
Verisyse® Phakic Intraocular lenses (IOLs) are indicated for the reduction or elimination of myopia in adults with myopia ranging from -5 D to -20 D with up to 2.5 D of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 mm; and, patients with documented stability of manifest refraction for the prior 6 months, as demonstrated by a spherical equivalent change of less than or equal to 0.50 D.
The Verisyse® Phakic lOL is contraindicated in patients: who are under 21 years old, with an anterior chamber depth (ACD) less than 3.2 mm, with an abnormal iris, such as peaked pupil or elevated iris margin, who are pregnant or nursing, who do not meet the minimum endothelial cell density.
Do not resterilize this intraocular lens by any method (See Returned Lens Policy). Do not store lenses at temperatures over 45˚C (113°F). Surgical difficulties at the time of intraocular lens implantation might increase the potential for complications (e.g. persistent bleeding, significant vitreous prolapse or loss). The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established. The long-term effect to the corneal endothelial cells has not been established. The relationship between the Verisyse® Phakic lOL and future lens opacities and retinal detachment is undetermined. The effect of the Verisyse® Phakic lOL on the future risk of glaucoma is unknown because its affects on the anterior chamber angle were not analyzed in the clinical trial. Approximately 1% of the subjects had elevated eye pressure that required glaucoma medication.
Prior to surgery, the surgeon must provide prospective patients with a copy of the patient information brochure for this product and inform these patients of the possible benefits and complications associated with the use of this device. A high level of surgical skill and training specific to irisfixated IOLs is required for lens implantation. One or more iridotomies/iridectomies should be performed to reduce risk of pupillary block. A cohesive high molecular weight viscoelastic is recommended for corneal protection and complete removal is recommended to reduce the chance of postop intraocular pressure (IOP) spikes. Low molecular weight non-cohesive viscoelastics should not be used. Patients with any of the following conditions may not be suitable candidates for this intraocular lens because the lens may exacerbate an existing condition or may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight: Abnormality of the iris or ocular structure that would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, coloboma, or microphthalmos, congenital bilateral cataracts, recurrent anterior or posterior segment inflammation, patients in whom the intraocular lens may interfere with the ability To observe, diagnose or treat posterior segment diseases, previous history of retinal detachment, patients with only one eye with potentially good vision, glaucoma. corneal endothelial dystrophy, proliferative diabetic retinopathy. The long-term effects of intraocular lens implantation have not been determined. Therefore, physicians should continue to monitor implant patients postoperatively on a regular basis. Annual exams are recommended. Elevated intraocular pressure has been reported occasionally in patients who received lens implants. The intraocular pressure of patients should be monitored postoperatively. Trauma is a risk factor for lOL dislocation. Visual acuity could be diminished in situations where there is low-level lighting. When pupil size is > optic size, there may be visual aberrations.
The most commonly reported adverse event occurring during the clinical trial of the Verisyse® Phakic lOL was surgical re-intervention (4.2%, 28/662). Of these, the most common interventions reported were lens explant (1.5%, 10/28) and lens exchange (1.4%, 9/28). Eyes with brown irises and pigment dispersal had a statistically significantly higher rate of IOP spikes (11.9%) than eyes with non-brown irises and pigment dispersion (3.1%) although, eyes with brown irises had significantly less pigment dispersion (15.3%) than eyes with non-brown irises (25.2%). Endothelial cell count data from the study indicated a continual steady endothelial cell loss of -1.8% per year and as this rate has not been established as safe, annual postoperative exams are recommended
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.