Clareon PanOptix Pro PXYAT0 (REF PXYAT0.240)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658493363), received between Dec 12, 2025 and Sep 15, 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
- Failure to Unfold or Unwrap1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Unfold or Unwrap
A non health professional reported that during an intraocular lens (IOL) implantation procedure stated that superman leading haptic stuck under posterior optic.Additional information has been received stating that there was no patient harm and the lens went in but surgeon was struggling with getting the haptic unstuck.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775794 ↗InjuryJul 8, 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 GLARE AND HALOS. THE CLINICAL REASON WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. THE LENS WAS EXPLANTED AND EXCHANGED FOR A NON-COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT GLARE AND HALOS WERE MADE WORSE BY PUPILLOPLASTY. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO OR CAUSED THE EVENT. THE SURGEON¿S PROGNOSIS PATIENT CONDITION WAS GOOD.
Patient problems: Visual Disturbances
MAUDE report 25745288 ↗MalfunctionJan 7, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS DEFECTIVE AND COULD NOT BE USED.
Patient problems: Insufficient Information
MAUDE report 23992293 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION AND CLINICAL REASON FOR EXPLANT BEING LENS MISCALCULATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNSPECIFIED ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23791187 ↗
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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