FDA.reportPublic FDA data

RayOne EMV

Primary DI
05029867006777
Brand
RayOne EMV
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
RAO200E
Catalog number
RAO200E/+23.5
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05029867006777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05029867006777050298670067775029867006777

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217427954
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05029867021527RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+2.252025-10-13
05029867021534RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+3.002025-10-13
05029867021541RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+3.752025-10-13
05029867021558RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+4.502025-10-13
05029867021565RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+1.502025-10-13
05029867021589RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+3.002025-10-13
05029867021596RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+3.752025-10-13
05029867021602RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+4.502025-10-13
05029867021619RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+1.502025-10-13
05029867021626RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+2.252025-10-13
05029867021640RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+3.752025-10-13
05029867021657RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+4.502025-10-13
05029867021664RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+1.502025-10-13
05029867021671RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+2.252025-10-13
05029867021688RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+3.002025-10-13
05029867021701RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+4.502025-10-13
05029867021718RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+1.502025-10-13
05029867021725RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+2.252025-10-13
05029867021732RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+3.002025-10-13
05029867021749RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+3.752025-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658439668ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439675ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439682ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439699ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439705ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439712ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439729ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439736ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439743ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439750ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439767ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439774ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439781ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439798ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439804ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439811ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439828ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439835ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439842ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439859ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439866ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439873ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439880ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439897ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439903ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439910ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439927ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439934ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439941ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439958ClareonAlcon Laboratories, Inc.HQL2026-08-27