FDA.reportPublic FDA data

Clareon TruPlus

Primary DI
00380658552022
Brand
Clareon TruPlus
Company
Alcon Laboratories, Inc.
Model
REYWT8
Catalog number
REYWT8.260
Device description
CLAREON TRUPLUS TORIC
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00380658552022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380658552022003806585520223806585520220380658552022

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
Length13Millimeter
Outer Diameter6Millimeter

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
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
00380658552183Clareon TruPlusREYWT9REYWT9.0752026-05-14

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