Clareon PanOptix Pro PXYWT3 (REF PXYWT3.190)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON PANOPTIX PRO TORIC · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658436759), received between Mar 11, 2026 and Jun 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 reports).
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
- Scratched Material2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SCRATCH WAS NOTICED WHEN DOCTOR LOOKED IN THE MICROSCOPE AFTER THE LENS WAS IMPLANTED. THE LENS WAS REMOVED FROM THE PATIENT EYE AND IMPLANT A NEW LENS. DOCTOR DO NOT KNOW IF THE LENS WAS ALREADY SCRATCHED PRIOR TO IMPLANT.
Patient problems: Insufficient Information
MAUDE report 25374650 ↗MalfunctionMar 11, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SCRATCH WAS NOTICED WHEN DOCTOR LOOKED IN THE MICROSCOPE AFTER THE LENS WAS IMPLANTED. THE LENS WAS REMOVED FROM THE PATIENT EYE AND IMPLANT A NEW LENS. DOCTOR DO NOT KNOW IF THE LENS WAS ALREADY SCRATCHED PRIOR TO IMPLANT.
Patient problems: Insufficient Information
MAUDE report 24574786 ↗
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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