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FDA Questions Missing Data, Sizing Method For Visian Astigmatism-Correcting Intraocular Lens

FDA is asking its Ophthalmic Devices Panel to consider the implications of missing data and issues with sizing methodology issues tied to Staar Surgical’s PMA submission for its Visian toric implantable collamer lens to correct myopic astigmatism in adults ages 21 to 45. The panel was scheduled for Feb. 14, but it has been postponed due to weather.

FDA has identified some potential safety concerns with Staar Surgical Co.’s Visian toric implantable collamer lens in advance of an advisory panel meeting to consider the firm’s PMA for the device to correct myopic astigmatism in adults.

The agency’s Ophthalmic Devices Panel will discuss Staar’s submission for the Visian TICL for what would be the first phakic, or nearsightedness, intraocular lens to gain approval for astigmatism correction,...

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