|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|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18. 0 through 25. 0 diopters to 15. 0 through 25. 0 diopters. The device, as modified, will be marketed under the trade name softec hd ps posterior chamber intraocular lens (pciol) and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.