| ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 10-105 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Don Calogero FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6483 don.calogero@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.3600 | Extended Depth Of Focus Intraocular Lens | Class 3 | POE |
| §886.3600 | Intraocular Lens | Class 3 | HQL |
| §886.3600 | Lens, Intraocular, Accommodative | Class 3 | NAA |
| §886.3600 | Lens, Intraocular, Toric Optics | Class 3 | MJP |
| §886.3600 | Lens, Iris Reconstruction | Class 3 | NIZ |
| §886.3600 | Lens, Multifocal Intraocular | Class 3 | MFK |
| Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff, Issued August 2015. |