Recognized Consensus Standards

Recognition List Number: 017 Publication Date: 05/21/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-40: ISO 11979-1 Second edition 2006-07-15, Ophthalmic implants -- Intraocular lenses - Part 1: Vocabulary. (Ophthalmic)

Date of Standard: 2006.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)
	DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)

Devices Affected:

Intraocular lenses (IOL)

Processes Affected:

510(k), PMA, IDE, PDP, HDE, Design Control Input

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard with the following advisory:

5.2 custom-made device
In general, IOLs do not meet the criteria for a custom device unless the change in design represents a new and unique concept that is unlikely to reoccur. See 520(b) of the FD&C Act for the statutory definition of "custom device." Please note that to be a custom device, all of the criteria listed in 520(b) must be met.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§886.3600	Intraocular Lens	Class 3	HQL
§886.3600	Lens, Intraocular, Toric Optics	Class 3	MJP
§886.3600	Lens, Iris Reconstruction	Class 3	NIZ
§886.3600	Lens, Multifocal Intraocular	Class 3	MFK
§886.3600	Lens,Intraocular,Accommodative	Class 3	NAA