Clareon PanOptix Pro PXYAT0 (REF PXYAT0.200)Recalls & reported problems
Alcon Laboratories, Inc. · CL PANOPTIX PRO 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658493288), received between Nov 27, 2025 and Jun 23, 2026 — classified as 1 injury, 3 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AS A RESULT THE IOL WAS EXCHANGED FOR ANOTHER NON COMPANY LIGHT ADJUSTABLE LENS (LAL) LENS 1 MONTH, 17 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. IN SURGEONS OPINION PRODUCT CAUSED THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 25594269 ↗MalfunctionMay 25, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LOADING THE LENS, THE LEADING HAPTIC FOLDED AROUND ONTO THE BACK OF THE OPTIC. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270850 ↗MalfunctionMay 19, 2026Material Twisted/Bent
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS MIS-SHAPED AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212984 ↗MalfunctionNov 27, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE SCRATCH WAS IDENTIFIED DURING THE IMPLANTATION PROCEDURE, PROMPTING REMOVAL OF THE IOL DURING THE INITIAL SURGERY. THERE WAS NO HARM TO THE PATIENT. THE PRELOADED LENS WAS CONTAMINATED AND THEREFORE, IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665287 ↗
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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