|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||THE SOFTEC HD IOL|
|Classification Name||intraocular lens|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Add three component washers for the use in the final clean area and inspection department to reduce bioburden and endotoxin of the intraocular lenses.