Clareon PanOptix Pro PXCWT0 (REF PXCWT0.215)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON PANOPTIX PRO UV · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658432997), received between Aug 29, 2025 and Sep 11, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 Problem2
- Scratched Material1
Patient problems
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced refractive error. The IOL was explanted and exchanged with an unspecified monofocal lens during a secondary implant procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Visual Impairment
MAUDE report 50732606 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION IN LEFT EYE, THE PATIENT EXPERIENCED EXTREME GLARE THROUGHOUT THE DAY AND WHEN DRIVING AT NIGHT. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS OF ONE DIOPTER MORE POWER IN A SECONDARY PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT .
Patient problems: Visual Disturbances
MAUDE report 25109327 ↗MalfunctionAug 29, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCHED LENS WAS IN THE EYE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 22920655 ↗
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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