FDA.reportPublic FDA data

Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe

Primary DI
00380652485005
Brand
Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe
Company
Alcon Laboratories, Inc.
Model
CCAET3
Catalog number
CCAET3.100
Device description
CLAREON UVA VIVITY TORIC AUTONOME
Published
2025-03-10
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
00380652485005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652485005003806524850053806524850050380652485005

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
05050474806153PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806177PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806207PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806214PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806238PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806245PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806252PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806269PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806276PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806306PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806320PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806344PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806351PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806368PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806375PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806412PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806429PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806450PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806481PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806511PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806535PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806542PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806566PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806597PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806603PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806610PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806641PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806658PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806689PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474818736PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16