DevicePMAs@therightstef:P910061_S013 / 360-367 JSONTXT

Approval for labeling changes for the advanced optics violet-shield model li61aov intraocular lens. The device, as modified, will be marketed under the trade name advanced optics violet-shield model li61aov intraocular lens and is indicated to be used for primary implantation for the correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular cataract extraction methods. The lens is intended for placement in the ciliary sulcus or capsular bag.

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PMA_MER 1 (1)