| ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics - Multifocal Intraocular Lenses |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-56 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 8.2. Requirements [for sterility/package integrity]. |
| 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 is recognized in part because: Clause 8.2 is in conflict with an existing published final guidance. See Recommendation #1 under Section V. B. Anterior Segment Solid Devices of the guidance document cited below.
This standard applies to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision. For the purposes of this standard, these implants are referred to as multifocal intraocular lenses (MIOLs). This standard does not consider optics designed to provide astigmatic power correction. The term "near vision", as used in this standard, includes useful vision at the distance of claimed benefit; e.g., near and/or intermediate distances.
| Regulation Number | Device Name | Device Class | Product Code |
| §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. |