Clareon PanOptix Pro PXCAT0 (REF PXCAT0.240)Recalls & reported problems
Alcon Laboratories, Inc. · CL PANOPTIX PRO 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
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380658490423), received between Jun 12, 2025 and Sep 29, 2026 — classified as 3 injuries, 3 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 Problem2
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Inaccurate Delivery1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- Blurred Vision2
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Posterior Capsule Opacification1
- Visual Disturbances1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced blurry visual acuity. The clinical reason for explant was maladaptation. The IOL was exchanged for a non-company light adjustable lens (LAL) model 06 months and 05 days following the initial implant procedure. In the surgeon's opinion the product caused or contributed to the event.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision
MAUDE report 50932883 ↗InjuryAug 12, 2026No Apparent Adverse Event
A facility representative reported that following an intraocular lens (IOL) implant procedure, the patient as could not tolerate halos and glare, could not adapt to lens, posterior capsule opacification and clinical reason for explant being -0.75 +1.00 X 5. Patient was not able to adapt the lens and posterior capsular opacification. In the surgeons opinion, some blur caused or contributed to the event. There was no further impact to the patient. The IOL was explanted and exchanged for a different diopter and model lens following the initial implant procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Posterior Capsule Opacification; Visual Disturbances
MAUDE report 50218157 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT HALF A DIOPTER LESS 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 24722204 ↗MalfunctionAug 29, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHILE ADVANCING THE LENS, THE PLUNGER BENT TO THE RIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22926008 ↗MalfunctionJul 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC ADVANCING STRAIGHT OUT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22602638 ↗MalfunctionJun 12, 2025Inaccurate Delivery; Material Twisted/Bent; Inaccurate Delivery; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT VISCOELASTIC MAY HAVE BEEN PLACED INTO THE INSERTER AFTER THE GUARD WAS REMOVED INSTEAD OF PRIOR AS PER INSTRUCTIONS.
Patient problems: Insufficient Information
MAUDE report 22192925 ↗
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.
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