| ANSI Z80.30-2018 American National Standard for Ophthalmics - Toric Intraocular Lenses |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-113 |
| 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 monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia. This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As applies to any standard, alternative validated test methods may be used.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.3600 | Lens, Intraocular, Toric Optics | Class 3 | MJP |
| §886.3600 | Phakic Toric Intraocular Lens | Class 3 | QCB |
| Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff, Issued August 2015. |