DevicePMAs@therightstef:P090022_S011 JSONTXT 11 Projects

Approval for modifications to the optic body shape and overalldiameter of your softec hd lens to introduce a lens with an ovoid optic and overall diameter of 12.50 mm and changes to your labeling related to the introduction of the modified lens. the device, as modified, will be marketed under the trade name softec hdo and is indicated for the replacement of the human crystalline lens following phacoemulsifica- tion cataract removal in adults over the age of 21. the lens is indicated for capsular bag placement.