Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

064

Date of Entry 05/26/2025

FR Recognition Number

10-137

Standard

ISO 11979-2 Third edition 2024-10
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods

Scope/Abstract

This document specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous vision, and/or accommodative optics. The generic descriptor 'IOL' used throughout this document also includes phakic intraocular lenses (PIOL).

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

NOTE: In the last sentence of Clause 4.1, the example in the phrase "...for example, by selecting an arbitrary meridian for measurement" suggests only one meridian for measurement. Testing should demonstrate that, as stated in Clause 4.1, rotationally symmetric IOL lenses meet the requirements in all meridians. We encourage you to contact the review division regarding rotationally symmetric IOLs requirements.

Transition Period

FDA recognition of ISO 11979-2 Second edition 2014-08 [Rec# 10-98] will be superseded by recognition of ISO 11979-2 Third edition 2024-10 [Rec# 10-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-98] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 10-98] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§886.3600	Intraocular Lens	Class 3	HQL
§886.3600	Lens, Multifocal Intraocular	Class 3	MFK
§886.3600	Lens, Intraocular, Toric Optics	Class 3	MJP
§886.3600	Lens, Intraocular, Accommodative	Class 3	NAA
§886.3600	Lens, Iris Reconstruction	Class 3	NIZ
§886.3600	Extended Depth Of Focus Intraocular Lens	Class 3	POE
N/A	Lens, Intraocular, Phakic	Class 3	MTA

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Simona Bancos

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

301-796-2243

simona.bancos@fda.hhs.gov

Bennett Walker

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

301-796-5093

Bennett.Walker@fda.hhs.gov

Janet Tang

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

Janet.Tang@fda.hhs.gov