FDA.reportPublic FDA data

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe

Primary DI
00380652460453
Brand
Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe
Company
Alcon Laboratories, Inc.
Model
CNAET5
Catalog number
CNAET5.200
Device description
CLAREON VIVITY TORIC AUTONOME
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00380652460453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652460453003806524604533806524604530380652460453

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

Sterilization Methods#

Method table
Method

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
true
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
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658544232Clareon TruPlusRECWT3RECWT3.0752026-03-23
00380658544249Clareon TruPlusRECWT3RECWT3.0802026-03-23
00380658544256Clareon TruPlusRECWT3RECWT3.0852026-03-23
00380658544263Clareon TruPlusRECWT3RECWT3.0902026-03-23
00380658544270Clareon TruPlusRECWT3RECWT3.0952026-03-23
00380658544287Clareon TruPlusRECWT3RECWT3.1002026-03-23
00380658544294Clareon TruPlusRECWT3RECWT3.1052026-03-23
00380658544300Clareon TruPlusRECWT3RECWT3.1102026-03-23
00380658544317Clareon TruPlusRECWT3RECWT3.1152026-03-23
00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
00380658544331Clareon TruPlusRECWT3RECWT3.1252026-03-23
00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
00380658544355Clareon TruPlusRECWT3RECWT3.1352026-03-23
00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
00380658544379Clareon TruPlusRECWT3RECWT3.1452026-03-23
00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05050474806160PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806184PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806191PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806221PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806283PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806290PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806313PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806337PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806382PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806399PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806405PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806436PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806443PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806467PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806474PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806498PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806504PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806528PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806559PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806573PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806580PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806627PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806634PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806665PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806672PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806696PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806702PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806719PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806726PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806733PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16