Clareon PanOptix Pro PXYAT3 (REF PXYAT3.195)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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658494254), received between Sep 8, 2025 and Aug 27, 2026 — classified as 2 injuries, 2 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 Problem2
- Device Difficult to Setup or Prepare1
- Material Deformation1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
A health care professional reported that after the intraocular lens (IOL) implantation surgery, the patient experienced discomfort. Hence the lens was explanted and replaced with another lens in a secondary procedure.
Patient problems: Visual Disturbances
MAUDE report 50474929 ↗MalfunctionApr 7, 2026Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT TRAILING HAPTIC FOLDED WRONG DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801964 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE IN READING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 12 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 24618282 ↗MalfunctionSep 8, 2025Material Deformation; Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTED GLISTENING IN THE IOL AFTER IMPLANTATION WHICH WERE VERY BRIGHT AND GLOWY. NOT LIKE THE AGING GLISTENINGS SEEN IN PRIOR MATERIAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PROCEDURE WAS COMPLETED ON THE SAME DAY. LENS REMAINS IMPLANTED. ALSO STATED THE GLISTENING'S WERE NOT VISIBLE ON VEDIOS.
Patient problems: Insufficient Information
MAUDE report 22994130 ↗
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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