Clareon PanOptix Pro PXCAT3 (REF PXCAT3.185)Recalls & reported problems

Alcon Laboratories, Inc. · CLRN PO PRO TORIC ATME UVA · Class 3 · Implant

All models of Clareon PanOptix Pro (222)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658491291), received between Nov 19, 2025 and May 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Dent in Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Dent in Material1
Device Difficult to Setup or Prepare1
Device Dislodged or Dislocated1
Inaccurate Information1

Patient problems

Insufficient Information3
Blurred Vision1
No Clinical Signs, Symptoms or Conditions1
Visual Disturbances1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 5, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAND PIECE WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25076732 ↗
MalfunctionApr 24, 2026Inaccurate Information
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE WRONG PRODUCT LETTER WAS WRITTEN ON THE COMPANY DEVICE STICKER. THE PROCEDURE WAS COMPLETED ON THE SAME DAY ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24987302 ↗
MalfunctionJan 8, 2026Dent in Material
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS EXCHANGED WITH A SAME MODEL AND DIOPTER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24003714 ↗
MalfunctionNov 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, IMMEDIATELY THE PATIENT EXPERIENCED BLURRY VISION AT ALL FOCAL LENGTHS. AFTER FIVE POST-OPERATION VISITS AND A SECOND OPINION THE PATIENT'S VISION REMAIN LESS THAN OPTIMAL. EVERYTHING, ESPECIALLY TEXT, HAD A GRAY DROP SHADOW AROUND IT AND IT WAS PARTICULARLY CLEAR AT ANY DISTANCE. THE SURGEON HAD NOTICED THAT THE LENS WAS SLIGHTLY OFF CENTER AND IT WAS NOT PROPERLY ROTATED, BUT THEY WAS NOT SURE CORRECTING THESE ISSUES WOULD RESOLVE THESE ISSUES AND SUGGESTED GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 23592883 ↗

Device details

UDI-DI	`00380658491291`
Brand	Clareon PanOptix Pro
Model	PXCAT3
Catalog no.	PXCAT3.185
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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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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