Clareon PanOptix Pro PXCAT0 (REF PXCAT0.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380658490409), received between Oct 23, 2025 and Jun 5, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND UNABLE TO SEE FAR OR NEAR. SUBSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED MONOFOCAL IOL IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS A MECHANICAL COMPLICATION OF THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS REPLACED WITH A NON-COMPANY LENS. THERE WAS NO FURTHER PATIENT IMPACT.

  Patient problems: Blurred Vision

  MAUDE report 25409799 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 25150681 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT LIKE THE RINGS. CLINICAL REASON PATIENT WANTED LENS OUT. THE IOL WAS EXCHANGED FOR LIGHT ADJUSTABLE LENS 03 MONTHS 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24397848 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT LIKE THE RINGS. CLINICAL REASON PATIENT WANTED LENS OUT. THE IOL WAS EXCHANGED FOR LIGHT ADJUSTABLE LENS 03 MONTHS 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24397847 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THE LENS DUE TO EXPERIENCING HALO EFFECTS AND SHADOWS. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 24364071 ↗
• MalfunctionFeb 2, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS STUCK IN DELIVERY SYSTEM. THE SECOND BACKUP LENS WITH SAME OCCURRENCE. THE SURGEON WAS ABLE TO MANUALLY FIX THIS WITH THE LESTER LENS MANIPULATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234522 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY DISTANCE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS OTHER MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24234456 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DVA (DISTANCE VISUAL ACUITY). CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON-COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23368861 ↗