Clareon PanOptix Pro PXCAT0 (REF PXCAT0.265)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658490478), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRED DISTANCE AND NIGHT VISION. THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 23849213 ↗
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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