| ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics - Phakic Intraocular Lenses |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-57 |
| 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 intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia or astigmatism.
| Lens, Refractive Intraocular | |||
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Lens, Intraocular, Phakic | Class 3 | MTA |
| Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2015. |