|Trade Name||CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS|
|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 for a trade name change of the memorylens iol. The device will be marketed under the trade name cv232 sre pre-rolled acrylic intraocular lens and is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age of older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.