FDA.reportPublic FDA data

Clareon Vivity

Primary DI
00380658454524
Brand
Clareon Vivity
Company
Alcon Laboratories, Inc.
Model
CNWET4
Catalog number
CNWET4-115
Device description
Clareon Vivity Toric
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
POEExtended Depth Of Focus Intraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POEExtended Depth Of Focus Intraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380658454524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380658454524003806584545243806584545240380658454524

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. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04
00380658454616Clareon VivityCNWET4CNWET4-1602026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658454418Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454425Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454432Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454449Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454456Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454463Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454470Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454487Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454494Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454500Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454517Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454531Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454548Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454555Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454562Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454579Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454586Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454593Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454609Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454616Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454623Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454630Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454647Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454654Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454661Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454678Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454685Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454692Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454708Clareon VivityAlcon Laboratories, Inc.POE2026-09-04
00380658454715Clareon VivityAlcon Laboratories, Inc.POE2026-09-04