|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||SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)|
|Classification Name||intraocular lens|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to reduce the size of the secondary packaging which houses the pouched intraocular lenses, label and directions for use (dfu). The device, as modified, will be marketed under the trade name softec hd, softec i, and softec hdo and is indicated for the replacement of the human crystalline lens following phacoemulsificaton cataract removal in adults over the age of 21.