Clareon PanOptix Pro PXCWT0 (REF PXCWT0.185)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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658432942), received between Mar 26, 2026 and Aug 18, 2026 — classified as 3 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 Problem3
Patient problems
- Blurred Vision2
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that after the intraocular lens (IOL) implantation surgery, the patient experienced blurry vision. Hence the lens was explanted and replaced with another lens in a secondary procedure. The clinical reason for explant was other mechanical complications of lens.
Patient problems: Blurred Vision
MAUDE report 50297995 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION WAS FOGGY, HALOS IN DAYTIME, CANNOT DRIVE. CLINICAL REASON BEING PATIENT UNHAPPY WITH VISION AFRAID TO DRIVE DUE TO HALOS. EXPLANT WAS PLANNED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THE FILE HAS BEEN UPDATED ACCORDINGLY.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 25475492 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT'S EYE DID NOT MATCH THE FORMULA.
Patient problems: Insufficient Information
MAUDE report 24698352 ↗
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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