DevicePMAs@therightstef:P060011_S005 JSONTXT 11 Projects

Approval for the following modifications of the c-flex aspheric iol model 970c: 1) increase of overall diameter from 12.00 mm to 12.50 mm; 2) increase of optic size from 5.75 mm to 6.00 mm; and 3) an extension of the high powered dioptric range from +30.0d to +34.0d. the device, as modified, will be marketed under the trade name 600c aspheric intraocular lens and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsificationthe lens is intended to be placed in the capsular bag.