Clareon PanOptix Pro PXYAT3 (REF PXYAT3.170)Recalls & reported problems
Alcon Laboratories, Inc. · CLRN PO PRO TORIC ATME BLF · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658494209), received between Dec 5, 2025 and Jun 10, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT NEAR AND DISTANCE, HAD HALOES AND GLARE, AND THESE SYMPTOMS WERE VERY BOTHERSOME. THE PATIENT WAS NOT ABLE TO TOLERATE THE MONOFOCAL LENS. THE PATIENT WAS ON OCULAR SURFACE TREATMENT, BUT THERE WAS NO IMPROVEMENT IN THE SYMPTOMS. HENCE, SURGEON PLANNED FOR LENS EXCHANGE. THERE WERE TWO MEDICAL REPORTS ASSOCIATED WITH THE SAME EVENT. THIS FILE BELONGED TO THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 25457255 ↗MalfunctionDec 8, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INJECTING INTO THE EYE, THE TRAILING HAPTIC WAS WRAPPED AROUND THE PLUNGER. IT WAS IMPLANTED BUT STILL HAD WRAPPED TRAILING HAPTIC. LENS WAS PLACED WITHOUT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23735885 ↗MalfunctionDec 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE TRAILING HAPTIC WAS WRAPPED AROUND THE PLUNGER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728583 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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