|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 INTROCULAR 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 for the softec hd iol to allow for the use of the medicel viscoject 1. 8, model# lp604350 with the softec hd and softec i iols.