DevicePMAs@therightstef:P910056_S010 11 Projects
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Approval for a material change and design modifications (3-piece to 1-piece design and aspheric surface) to the approved bausch & lomb silicone lens c31ub. The device, as modified, will be marketed under the trade name envista one-piece hydrophobic acrylic intraocular lens, model mx60 and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous crystalline lens has been removed.
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