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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 059 Date of Entry 12/19/2022 
FR Recognition Number 10-133
Standard
ISO  11979-10 Second edition 2018-03
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
Scope/Abstract
ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.

There are three main categories of phakic intraocular lenses depending on the optical design:

a) Phakic monofocal (PIOL);

b) Phakic multifocal (PMIOL); and

c) Phakic toric (PTIOL).

Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.

The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.

ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.

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)*
Regulation Number Device Name Device Class Product Code
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Phakic Toric Intraocular Lens Class 3 QCB
N/A Lens, Intraocular, Phakic Class 3 MTA
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
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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