DevicePMAs@therightstef:P080004_S012 11 Projects
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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.
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