Clareon PanOptix Pro PXCAT0 (REF PXCAT0.195)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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658490331), received between Oct 29, 2025 and Aug 7, 2026 — classified as 3 injuries, 1 malfunction.
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
Patient problems
- Blurred Vision2
- Visual Disturbances2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
A non-health professional reported that following surgery, the patient experienced blurry visual acuity (VA),dysphotopsia left eye (OS). The clinical reason for explant was dysphotopsia. The IOL was replaced with another company lens. As a result, the intraocular lens (IOL) was explanted 4 months, 4 days after the initial implant procedure.There are two medical reports associated with this patient. This file belongs to right eye.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50176466 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTY WITH BOTH DISTANCE AND INTERMEDIATE (COMPUTER) VISION. THE IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A MONOFOCAL LENS DURING A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS IDENTIFIED AS A MECHANICAL COMPLICATION OF THE ORIGINAL IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24268804 ↗MalfunctionJan 16, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGERY WAS COMPLETED USING BACK UP LENS WITHOUT ANY HARM TO THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24092813 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED DYSPHOTOPSIA. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS ALSO CITED AS DYSPHOTOPSIA. THE PATIENT'S SYMPTOMS WERE RESOLVED, AND THE SURGEON REPORTED A GOOD PROGNOSIS. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 23412782 ↗
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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