Clareon PanOptix Pro PXCAT0 (REF PXCAT0.175)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658490294), received between Jul 21, 2025 and Jul 3, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Blurred Vision1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 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 BLURRY VISION. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON-COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO FURTHER CONSEQUENCES TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 25704830 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POOR VISUAL QUALITY. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 25328618 ↗MalfunctionJul 21, 2025Use of Incorrect Control/Treatment Settings; Device Dislodged or Dislocated; Use of Incorrect Control/Treatment Settings; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPLANTED IOL WITH REASON WRONG AXIS. CLINICAL REASON FOR THE EXPLANT IS IOL NOTED TO BE SUBLUXED INFERIORLY. THE LENS WAS REPLACED WITH DIFFERENT MODEL COMPANY LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING AS PER THE SURGEON OPINION PATIENT HAD BEEN A RESTLESS SLEEPER SINCE SURGERY AND REPORT IT IS POSSIBLE, HE ACCIDENTALLY RUBBED OR MANIPULATING EYE HAS CONTRIBUTED TO THE CAUSE OF EVENT. PATIENT SYMPTOMS WERE STILL CONTINUING.
Patient problems: Insufficient Information
MAUDE report 22559649 ↗
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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