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Refractive implant guidance

This article was originally published in The Gray Sheet

Executive Summary

Comments on FDA's draft guidance on IDE and PMA submissions for refractive implants are due by Oct. 30. Released Aug. 1, the document applies to "any ocular implant whose primary indication is the modification of the refractive power of a phakic eye to improve distance and/or near uncorrected visual acuity [and] any intraocular lens intended for clear lens exchange." The draft notes that sponsors that pursue clear lens exchange as a refractive indication should be aware that FDA may recommend additional safety and efficacy endpoints. Members of FDA's Ophthalmic Devices Advisory Panel noted at a May 12 meeting that clear lens exchange holds an increased risk for retinal detachment. They also expressed anxiety over including phakic IOL implementation and IOL clear lens exchange procedures in the same guidance since the risk/benefit ratio and possible rates of adverse events were different for each procedure
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