Clareon PanOptix Pro PXCAT0 (REF PXCAT0.200)Recalls & reported problems
Alcon Laboratories, Inc. · CL PANOPTIX PRO ATME UVA · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380658490348), received between Nov 14, 2025 and Apr 24, 2026 — classified as 5 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Visual Disturbances5
- Blurred Vision2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD EXPERIENCED HALOS AND GLARE. THE IOL WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED MONOFOCAL INTRAOCULAR LENS DURING A SECONDARY IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION HAD BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 24979352 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOS, GLOWS, COULD NOT SEE, BLURRY VISION AND NO COLORS. CLINICAL REASON BEING MENTIONED AS PATIENT DISSATISFACTION. THE IOL WAS EXPLANTED AND EXCHANGED WITH A WITH NON-COMPANY LENS INTRAOCULAR LENS IN THE SECONDARY IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE RESOLVED. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO OR CAUSED THE EVENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24979140 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA.
Patient problems: Visual Disturbances
MAUDE report 24664233 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS AND RINGS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN VIVITY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 24093162 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD BLURRY VISION AT ALL DISTANCES. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WERE, DYSPHOTOPSIA, ANISEKONIA, AND ANISOMETROPIA. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SURGEON REPORTED THAT THE ADVERSE EVENTS EXPERIENCED BY THE PATIENT WERE DUE TO THE IOL. THE LENS EXCHANGE WAS DONE WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT, AND THE SURGEON CONFIRMED THAT THE PATIENT IS DOING WELL.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 23553104 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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