DevicePMAs@therightstef:P050034_S000 JSONTXT 11 Projects

Approval for the imt models wide angle 2.2x and wide angle 2.7x. this device is indicated for monocularimplantation to improve vision in patients greater than or equal to 75 years of age with stablesevere to profound vision impairment (best corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular degeneration. Patients must: 1) have retinal findings of geographic atrophy or disciform scar with foveal involvement, asdetermined by fluorescein angiography; 2) have evidence of visually significant cataract (> grade 2);3) agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with lowvision specialists (optometrist or occupational therapist) in the use of an externaltelescope sufficient for patient assessment and for the patient to make an informeddecision; 4) achieve at least a 5-letter improvement on the etdrs chart with an external telescope; 5) have adequate peripheral vision in the eye not scheduled for surgery; and6) agree to participate in postoperative visual training with a low vision specialist.