DevicePMAs@therightstef:P090022_S001 11 Projects
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Approval for modifications to the optic design of the softec hd lens to introduce bi-spheric optic surfaces and changes to the labeling related to the introduction of the modified lens. The device, as modified, will be marketed under the trade name softec i and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag replacement.
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