|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS|
|Classification Name||intraocular lens|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
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.