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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 10-56
Standard
ANSI  Z80.12-2007 (R2022)
American National Standard for Ophthalmics - Multifocal Intraocular Lenses
Scope/Abstract
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.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 8.2. Requirements [for sterility/package integrity].
Rationale for Recognition
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
Relevant FDA Guidance and/or Supportive Publications*
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6483
  don.calogero@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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