|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 (PCIOL)|
|Classification Name||intraocular lens|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the optic body shape and overall diameter 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.