| ANSI Z80.29-2015 American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| Recognition Number | Ophthalmic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 10-115 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.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 standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs).
| Regulation Number | Device Name | Device Class | Product Code |
| §886.3600 | Lens, Intraocular, Accommodative | Class 3 | NAA |
| Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 17, 2015. |