| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
040
|
Date of Entry 08/14/2015
|
|
FR Recognition Number
|
10-98
|
| Standard | |
ISO 11979-2 Second edition 2014-08-15
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
|
Scope/Abstract| This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor 'IOL' used throughout this document also includes phakic intraocular lenses (PIOL). |
|
| Extent of Recognition
|
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. |
|
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
|
| 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 Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
