|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|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to amend the approved labeling to allow for the use of the asico softip injection system, model number as-9300 with the softec hd, softec i and softec hd ps intraocular lenses (iols).