|Trade Name||ISERT MODEL PC-60AD PACKAGING IMPROVEMENT|
|Classification Name||intraocular lens|
|Applicant||HOYA SURGICAL OPTICS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a packaging configuration change for the isert model pc-60ad intraocular lens (iol). The device, as modified, will be marketed under the trade name isert model 230 and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.