FDA.report

Clareon™

Primary DI
00380652469944
Brand
Clareon™
Company
Alcon Laboratories, Inc.
Model
CNWTT6
Device description
STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens
Published
2021-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MJPLENS, INTRAOCULAR, TORIC OPTICS

Product Code Classifications

CodeDeviceSpecialtyClass
MJPLens, Intraocular, Toric OpticsOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380652469944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652469944003806524699443806524699440380652469944

GMDN Terms

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.

Sterilization Methods

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
false
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 DIBrandModelCatalogPublished
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
00380658544416Clareon TruPlusRECWT3RECWT3.1652026-03-23
00380658544423Clareon TruPlusRECWT3RECWT3.1702026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00380658544232Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544249Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544256Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544263Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544270Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544287Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544294Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544300Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544317Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544324Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544331Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544348Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544355Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544362Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544379Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544386Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544393Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544409Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544416Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544423Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544430Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544447Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544454Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544461Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544478Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544485Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544492Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544508Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544515Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23
00380658544522Clareon TruPlusAlcon Laboratories, Inc.MJP2026-03-23