Clareon PanOptix Pro PXCAT3 (REF PXCAT3.120)Recalls & reported problems
Alcon Laboratories, Inc. · CLRN PO PRO TORIC 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 00380658491161), received between Dec 19, 2025 and Jun 12, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Fold” (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
- Failure to Fold1
Patient problems
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD FLUCTUATING VISION AND BLURRINESS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS OTHER MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 25487299 ↗MalfunctionDec 19, 2025Failure to Fold; Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD LOADING ISSUE WITH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23850386 ↗
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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