FDA.report

Clareon PanOptix Pro

Primary DI
00380658492014
Brand
Clareon PanOptix Pro
Company
Alcon Laboratories, Inc.
Model
PXCAT4
Catalog number
PXCAT4.300
Device description
CLRN PO PRO TORIC ATME UVA
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MFKLens, Multifocal Intraocular

Product Code Classifications

CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380658492014PrimaryGS10

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
true
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

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Primary DIBrandCompanyProduct codePublished
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