FDA.reportPublic FDA data

AcrySof™ IQ Vivity™

Primary DI
00380652427821
Brand
AcrySof™ IQ Vivity™
Company
Alcon Laboratories, Inc.
Model
DAT415
Catalog number
DAT415.155
Device description
Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00380652427821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652427821003806524278213806524278210380652427821

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
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

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
00380658454524Clareon 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