Clareon PanOptix Pro PXCAT3 (REF PXCAT3.225)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
- 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 00380658491376), received between Nov 28, 2025 and Mar 9, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Material Deformation1
Patient problems
- Visual Disturbances2
- Visual Impairment2
- Blurred Vision1
- Diplopia/Double Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Material Deformation
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DAMAGED ONCE INSERTED . THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY USING BACK IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24546767 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED GLARE AND CHANGES IN COLOR PERCEPTION. THE LENS WAS EXPLANTED AND REPLACED WITH A TORIC LENS DURING A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 23988969 ↗MalfunctionDec 26, 2025Activation Problem; Activation Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS ADVANCED TOO SOON. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SURGERY WAS COMPLETED ON THE SAME DAY USING A REPLACEMENT LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895799 ↗InjuryDec 5, 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 WAS UNABLE TO TOLERATE GLARE AND HALOS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS CONTINUED DIFFICULTY WITH VISION, SEEING MULTIPLE IMAGES, AND SIGNIFICANT SENSITIVITY TO LIGHT WITH SEVERE SUBJECTIVE HALO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Diplopia/Double Vision; Visual Disturbances
MAUDE report 23727984 ↗InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. CLINICAL REASON BEING MENTIONED AS BCVA 20/30 -2. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO OR CAUSE THE EVENT. IN THE SURGEON¿S PROGNOSIS, THE PATIENT CONDITION WAS GOOD AND ISSUES WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23671503 ↗
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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