Clareon PanOptix Pro PXCAT0 (REF PXCAT0.160)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658490263), received between Sep 4, 2025 and Dec 15, 2025 — classified as 1 injury, 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 Problem1
- Device Difficult to Setup or Prepare1
Patient problems
- Blurred Vision1
- Halo1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS ABLE TO SEE DISTANCE ONE DAY LATER THE SURGERY. AFTER A WEEK SINCE SURGERY SHE CANNOT READ OR SEE NEAR AND EXPERIENCED BLURRY VISION. AT NIGHT THE HALOS AROUND EVERY LIGHT SOURCE ARE SIGNIFICANT. ABOUT 4-5 RINGS AROUND HEADLIGHTS AND STREETLIGHTS. IT MAKES IT DIFFICULT TO READ STREET SIGNS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT ALSO EXPERIENCED BLURRY VISION AT INTERMEDIATE DISTANCE AND SEVERE STARBURST AROUND LIGHT SOURCES AT NIGHT. AT ONE WEEK POST-OPERATIVE VISIT THE EYE LOOKS HEALTHY AND SEEMS TO BE HEALING WITH VERY LITTLE SWELLING AND DOCTOR SUGGESTED USING DRY EYE MOISTURIZING DROPS.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 23803656 ↗MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS NOT TUCKED AND WAS LEADING THE LENS WHEN THE DOCTOR WENT TO PUT IT IN THE EYE. SHE DID NOT WANT TO USE IT BECAUSE THE HAPTIC WAS LEADING. THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22962792 ↗
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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