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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 10-91
ISO 11979-10 First edition 2006-08-15
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses [Including: Amendment 1 (2014)]
ISO 11979-10:2006 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.

ISO 11979-10:2006 addresses specific requirements for PIOLs not addressed in the other parts of ISO 11979.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Lens, Refractive Intraocular
Regulation Number Device Name Device Class Product Code
Unclassified Lens, Intraocular, Phakic Class 3 MTA
FDA Technical Contact
 Don Calogero
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.