Clareon PanOptix Pro PXCAT3 (REF PXCAT3.190)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658491307), received between Aug 25, 2025 and Feb 27, 2026 — classified as 2 injuries.
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
Patient problems
- Visual Impairment2
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. THE PATIENT AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS WRONG POWER. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Visual Impairment
MAUDE report 24470512 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY OF VISION. THE IOL WAS REPLACED WITH A NON-COMPANY LENS 1 MONTH, 2 WEEKS, 4 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS POOR QUALITY OF VISION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT'S POST-OPERATIVE EXPERIENCE. AT ONE-WEEK POST-OP, THE UNCORRECTED NEAR VISUAL ACUITY (UCNVA) WAS REPORTED TO BE LESS THAN EXPECTED. BY THE SECOND WEEK, THE PATIENT NOTED EXPERIENCING HALOS AND CONTINUED TO HAVE LIMITED NEAR VISION. THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) AND UCNVA REMAINED BELOW ANTICIPATED LEVELS. ON (B)(6) 2025, THE PATIENT REPORTED THAT VISION IN THE LEFT EYE (OS) CONTINUED TO OUTPERFORM THE RIGHT EYE (OD). THE FOLLOWING DAY, (B)(6) 2025, THE PATIENT EXPERIENCED POOR QUALITY OF VISION AND WISHED TO PROCEED WITH LENS EXCHANGE IN RIGHT EYE. THERE WAS NO FURTHER HARM TO THE PATIENT.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 22885321 ↗
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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