Hawaiian Eye/Retina Meeting

Hawaiian Eye/Retina Meeting

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January 19, 2022
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VIDEO: AcuFocus executive on what ‘approvable letter’ means for IC-8 IOL

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WAIKOLOA, Hawaii — Yari L. Mitchell, chief business development officer at AcuFocus, updates the approval process and progress for the IC-8 small aperture IOL.

“We recently received an ‘approvable letter’ from the FDA, which we are incredibly excited about,” Mitchell said here at Hawaiian Eye 2022. “What this means, is that the agency has received our PMA, has reviewed it, and we have met the requirements for approval.”