Clareon PanOptix Pro PXCAT0 (REF PXCAT0.295)Recalls & reported problems

Alcon Laboratories, Inc. · CL PANOPTIX PRO ATME UVA · Class 3 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658490539), received between Nov 17, 2025 and Nov 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Difficult to Setup or Prepare1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 17, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED DUE TO LEADING HAPTIC ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23568071 ↗

Device details

UDI-DI	`00380658490539`
Brand	Clareon PanOptix Pro
Model	PXCAT0
Catalog no.	PXCAT0.295
Company	Alcon Laboratories, Inc.
Product code	MFK · Lens, Multifocal Intraocular
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 9, 2025

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An 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.

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All Lens, Multifocal Intraocular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.