|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 POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)|
|Classification Name||intraocular lens|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the directions for use to include a warning that enhances the safety in the use of the device.