|Trade Name||ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5|
|Classification Name||intraocular lens|
|Generic Name||intraocular lenses (iol)21 cfr 886.3600/class iii|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for iol models sn60t3, sn60t4 and sn60t5. The device, as modified, will be marketed under the trade name acrysof toric single-piece natural iol and is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved spectacle independence for distance vision.