Clareon PanOptix Pro PXCAT3 (REF PXCAT3.205)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
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380658491338), received between Dec 12, 2025 and Sep 24, 2026 — classified as 3 injuries, 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 Problem3
- Device Difficult to Setup or Prepare1
- Scratched Material1
Patient problems
- Blurred Vision2
- No Clinical Signs, Symptoms or Conditions2
- Dry Eye(s)1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device Difficult to Setup or Prepare
A facility representative reported during intraocular lens (IOL) implant procedure, leading haptic was sticking out. There was no patient contact and there was no patient harm.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882138 ↗InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED PRESBYOPIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ATIOL (ADVANCED TECHNOLOGY INTRA OCULAR LENS) IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 25828207 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION, DRY EYE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER (NON-COMPANY) LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS COULD NOT NEUROADAPTIVE THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision; Dry Eye(s)
MAUDE report 24999686 ↗MalfunctionJan 22, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH OR MARK ON THE OPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148212 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE DYSPHOTOPSIAS AND STARBURSTS AND DID NOT FEEL SAFE DRIVING AT NIGHT. THE LENS WAS EXPLANTED AND REPLACED WITH A OTHER COMPANY MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIAS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 23787236 ↗
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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