FDA.reportPublic FDA data

Clareon PanOptix Pro

Primary DI
00380658494421
Brand
Clareon PanOptix Pro
Company
Alcon Laboratories, Inc.
Model
PXYAT3
Catalog number
PXYAT3.280
Device description
CLRN PO PRO TORIC ATME BLF
Published
2025-03-31
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
MFKLens, Multifocal Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380658494421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380658494421003806584944213806584944210380658494421

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
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05029867007026RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007033RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007040RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007057RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007064RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007071RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007088RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007095RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007101RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007118RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007125RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007132RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007149RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007156RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007163RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007170RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007187RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007194RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007200RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007217RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007224RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007231RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007248RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007255RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007262RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007279RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007286RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007293RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007309RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007316RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29