DevicePMAs@therightstef:P100016_S001 JSONTXT 11 Projects

Approval for a change to the trade name of the approved lenses and labeling changes to the unit carton, including a change to the color scheme and format. the device, as modified, will be marketed under the trade name aaris acrylic intraocular lens (iol), models ec-3 and ec-3 precision aspheric lens (pal) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.