FDA.reportPublic FDA data

Clareon

Primary DI
00380652431590
Brand
Clareon
Company
Alcon Laboratories, Inc.
Model
CCW0T3
Catalog number
CCW0T3.080
Device description
CLAREON TORIC UVA
Published
2025-11-13
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
MJPLens, Intraocular, Toric Optics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJPLens, Intraocular, Toric OpticsOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380652431590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652431590003806524315903806524315900380652431590

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

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
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380658539702Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539719Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539726Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539733Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539740Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539757Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539764Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539771Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539788Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539795Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539801Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539818Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539825Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539832Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539849Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539856Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539863Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539870Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539887Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539894Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539900Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539917Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539924Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539931Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539948Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539955Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539962Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539979Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539986Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13
00380658539993Clareon TruPlusAlcon Laboratories, Inc.MJP2026-04-13