Clareon PanOptix Pro PXYAT0 (REF PXYAT0.215)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
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380658493318), received between Aug 15, 2025 and Aug 30, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 reports).
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
- Device Difficult to Setup or Prepare2
- Failure to Advance1
- Failure to Deliver1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50514716 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
A nonhealth care professional reported that after the intraocular lens (IOL) implantation surgery, the patient could not see. Hence the lens was explanted and replaced with another monofocal lens in a secondary procedure. The clinical reason for explant was refractive surprise.Additional information was received stating that the patient's issue resolved and there was no further harm to the patient.
Patient problems: Visual Impairment
MAUDE report 50407725 ↗MalfunctionAug 12, 2026Product Quality Problem
A non-healthcare professional reported that, during intraocular lens implantation surgery, a notch or divot was found on the lens near the leading haptic. The procedure was completed the same day. There was no patient contact. Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222816 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT WAS UNABLE TO TOLERATE VISUAL DISTURBANCES AND HALOS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS INTOLERANCE TO HALOS.
Patient problems: Visual Disturbances
MAUDE report 24884264 ↗MalfunctionMar 30, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION THAT THE LENS WAS BEING ADVANCED BY THE PLUNGER TIP. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715689 ↗MalfunctionJan 2, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THERE WAS AN ISSUE WITH LENS, THAT DID NOT DEPLOY CORRECTLY. THE PLUNGER RODE UNDER THE LENS AND DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23942559 ↗MalfunctionSep 8, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, COMPANY IOL DIDN'T WORK AS EXPECTED. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED BY USING BACKUP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993770 ↗MalfunctionAug 15, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS HAD BECOME STUCK IN THE CARTRIDGE AND WOULD NOT ADVANCE AS EXPECTED. THE REPORTER CONFIRMED THAT THE DEVICE HAD MADE CONTACT WITH THE PATIENT DURING THE ATTEMPT. DESPITE THE ISSUE, THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22814325 ↗
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.
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