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Clareon PanOptix Pro

FDA UDI

Class III (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name
Clareon PanOptix Pro FDA UDI
Generic Name
Posterior-chamber intraocular lens, pseudophakic FDA UDI
Device Name
CLRN PO PRO TORIC ATME UVA FDA UDI
Model / Reference
PXCAT4 FDA UDI
Description
CLRN PO PRO TORIC ATME UVA FDA UDI

Identifiers

Catalog Number
PXCAT4.085 FDA UDI
Primary DI / UDI-DI
00380658491581 FDA UDI
FDA Product Code
MFK FDA UDI
GMDN Term
Posterior-chamber intraocular lens, pseudophakic FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Posterior-chamber intraocular lens, pseudophakic

Clareon PanOptix Pro by Alcon Laboratories, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Posterior-chamber intraocular lens, pseudophakic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alcon Laboratories, Inc.

Sources (1)

  • FDA UDI 3420f4ef-32c9-4d28-8dc6-ed9cea10bf0c 35 fields · synced May 30, 2026