Clareon PanOptix Pro PXCAT0 (REF PXCAT0.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380658490386), received between Oct 15, 2025 and Sep 18, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  A consumer (pharmacist) reported that following an intraocular lens (IOL) implantation procedure, flickering vision, cloudy vision, foggy vision, and dimmer, worse vision were experienced by the patient immediately after the procedure. Vision was reported to be worse under fluorescent lighting and improved outdoors. The symptoms persisted despite continued use of prescribed eye drops and interfered with the patient's ability to check prescriptions, requiring use of a magnifying glass. At follow-up, visual acuity was reported as 20/25, and the patient was advised to allow additional time for healing and informed that reading glasses might be needed.There are two Medical Device Reports associated with this patient. This report is associated with the left eye.

  Patient problems: Blurred Vision

  MAUDE report 50818041 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced waxy vision. Clinical reason being mentioned as contrast loss due to diffracting optic. The IOL was explanted and exchanged for an unknown ATIOL (advanced technology intraocular lens) in the secondary implant procedure. Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision

  MAUDE report 50565701 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE NIGHT HALOS EVEN WITH -0.50 RESIDUAL MYOPIA WITH DAY AND NEAR VISION WAS GOOD. THE LENS WAS EXPLANTED AND REPLACED WITH AN NONCOMPANY LENS 25 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS HALOS/NIGHTTIME DYSPHOTOPSIA WHICH WAS MUCH MORE INTENSE THAN EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED

  Patient problems: Visual Disturbances

  MAUDE report 25329719 ↗
• MalfunctionMar 24, 2026Break; Device Damaged by Another Device

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THEY OBSERVED A BENT/BROKEN HAPTIC. PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 24673424 ↗
• MalfunctionMar 18, 2026Break; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF BROKEN INTRAOCULAR LENS (IOL) HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24629457 ↗
• InjuryMar 16, 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 DISTANCE NIGHT VISION WAS NOT GOOD AND CANNOT READ. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 24613706 ↗
• InjuryDec 26, 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) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR NON-COMPANY LENS WITH DIFFERENT DIOPTER 01 MONTH 25 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT NEEDED DISTANCE GOAL. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23897390 ↗
• MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LEADING HAPTIC WAS BENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497045 ↗
• MalfunctionOct 20, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WAS OPENED ONTO THE FIELD AND FOUND TO BE ¿DEFECTIVE. NO PATIENT CONTACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334845 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASED QUALITY OF VISION BOTH NEAR & FAR AND CLINICAL REASON AS POOR ADAPTATION TO DIFFRACTIVE MULTIFOCAL. THE IOL WAS REPLACED WITH MONOFOCAL COMPANY LENS 2MONTHS 24DAYS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23293103 ↗