Ophtec BV
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Latest From Ophtec BV
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.
AMO Puts a New Spin on Ophthalmic Devices
Once part of Allergan, Advanced Medical Optics was spun off when its parent company wanted to focus on pharmaceuticals. Executives of the new company believe that life as an independent medical device company gives it the freedom to operate and the focus it needs to thrive in the ophthalmic device market.
In the spin-out, AMO got market-leading brands with an almost 40 year history, an ophthalmic sales force that has just about the longest continuity in the industry, and strong management with a track record more than two decades long.
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