| ISO 11979-10 First edition 2006-08-15 Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)] |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 10-91 |
| 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.
ISO 11979-10:2006 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
ISO 11979-10:2006 addresses specific requirements for PIOLs not addressed in the other parts of ISO 11979.
| Lens, Refractive Intraocular | |||
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Lens, Intraocular, Phakic | Class 3 | MTA |
| There is no relevant guidance developed at this time. |