Clareon PanOptix Pro PXCAT6 (REF PXCAT6.225)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658492847), received between Sep 17, 2025 and Feb 27, 2026 — classified as 1 injury, 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Inaccurate Delivery1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Inaccurate Delivery
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS STARTED TO BE IN PLACE AND THEN EJECTS ITSELF AND DEEMED FAULTY. THE TECH STATED THAT, THE PROVIDER MAY BE STARTING TO DEPLOY THE LENS PRIOR TO BE FULLY INSERTED AND SO THE LENS STARTED TO BE IN PLACE AND THEN EJECTS ITSELF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24469477 ↗InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT TWO DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision
MAUDE report 24340728 ↗MalfunctionSep 17, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED TROUBLE IN HAPTIC DURING LOADING. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH SAME MODEL AND DIOPTER COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23072721 ↗
Other Lens, Multifocal Intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page