|Trade Name||ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER|
|Classification Name||intraocular lens|
|Generic Name||intraocular lens|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed. The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.