Clareon PanOptix Pro PXYAT0 (REF PXYAT0.195)Recalls & reported problems
Alcon Laboratories, Inc. · CL PANOPTIX PRO ATME BLF · Class 3 · Implant
All models of Clareon PanOptix Pro (222)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658493271), received between Feb 27, 2026 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Failure to Advance1
- Failure to Deliver1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A non health professional reported that following surgery. The IOL was replaced with an another non company lens. As a result, the intraocular lens (IOL) was explanted 6 months, 24 days, after the initial implant procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50815172 ↗InjuryAug 27, 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 with poor/blurry vision with shadowing around letters. The lens was exchanged for another lens model 01 month 04 days following the initial procedure. Clinical reason for explant was mentioned as unexpected refractive error. Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 50470617 ↗MalfunctionFeb 27, 2026Failure to Deliver; Failure to Advance
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT DEPLOY CORRECTLY AND PLUNGER RODE OVER THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469475 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page