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.
Rationale
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.