DevicePMAs@therightstef:P860002_S018 JSONTXT 11 Projects

Approval to modify the directions for use for all legally marketed iols under the referenced pmas, to indicate the iols for use in adult patients. Previously, the iols were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods.