FDA.reportPublic FDA data

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe

Primary DI
00380652459761
Brand
Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe
Company
Alcon Laboratories, Inc.
Model
CNAET3
Catalog number
CNAET3.215
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
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
00380652459761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652459761003806524597613806524597610380652459761

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
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
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14
00380658552060Clareon TruPlusREYWT8REYWT8.2802026-05-14
00380658552077Clareon TruPlusREYWT8REYWT8.2852026-05-14
00380658552084Clareon TruPlusREYWT8REYWT8.2902026-05-14
00380658552091Clareon TruPlusREYWT8REYWT8.2952026-05-14
00380658552107Clareon TruPlusREYWT8REYWT8.3002026-05-14
00380658552114Clareon TruPlusREYWT8REYWT8.3102026-05-14
00380658552121Clareon TruPlusREYWT8REYWT8.3202026-05-14
00380658552138Clareon TruPlusREYWT8REYWT8.3302026-05-14
00380658552145Clareon TruPlusREYWT8REYWT8.3402026-05-14
00380658552152Clareon TruPlusREYWT9REYWT9.0602026-05-14
00380658552169Clareon TruPlusREYWT9REYWT9.0652026-05-14
00380658552176Clareon TruPlusREYWT9REYWT9.0702026-05-14

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