FDA Questions Missing Data, Sizing Method For Visian Astigmatism-Correcting Intraocular Lens
This article was originally published in The Gray Sheet
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.
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FDA’s Ophthalmic Devices Panel voted in favor of Staar Surgical’s Visian toric implantable collamer lens to correct myopic astigmatism in adults ages 21 to 45. Earlier safety and missing data questions on the lenses were reviewed, but ultimately, the panel said the product’s proposed indication outweighed risk for use in specified patients.
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