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Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications Ingestion-build-183098 BS EN 16615 applies to1 Scope This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1 9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its