|Trade Name||ACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS|
|Classification Name||intraocular lens|
|Generic Name||intraocular lenses|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the package insert to create a new warning by moving and strengthening existing text within the approved insert to read as follows: "the clinical study of the acrysof natural single-piece lens (referenced in tables 2 through 5) was conducted with the lens intended for implantation in the capsular bag only. There is no clinical data to demonstrate its safety and effectiveness for placement in the ciliary sulcus. ".