Clareon PanOptix Pro PXCAT0 (REF PXCAT0.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380658490416), received between Nov 11, 2025 and Apr 24, 2026 — classified as 3 injuries, 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH NON-COMPANY LENS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24984032 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY STATING THERE WAS NO FURTHER IMPACT TO THE PATIENT. IN THE SURGEON¿S OPINION LENS WAS CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Blurred Vision

  MAUDE report 24279345 ↗
• InjuryDec 2, 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 GLARE AND NOT HAPPY WITH VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 2 MONTHS AND 16 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23693493 ↗
• MalfunctionNov 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE TRYING TO ADVANCE THE LENS THE CO2 CARTRIDGE STARTED HISSING AND LOOKED LIKE SMOKE COMING OUT OF THE LENS DELIVERY SYSTEM UNDER THE MICROSCOPE. LENS WAS ABLE TO BE IMPLANTED BUT IT TOOK A LOT OF MANEUVERING BEING LOST MOMENTUM BEFORE THE LENS WAS ABLE TO BE FULLY INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN THE SURGEON¿S OPINION, BROKEN CO2 CANNISTER CAUSED OR CONTRIBUTED TO THE EVENT. THE LENS WAS LEFT IMPLANTED WITH NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520271 ↗
• MalfunctionNov 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE TRYING TO ADVANCE THE LENS THE CO2 CARTRIDGE STARTED HISSING AND LOOKED LIKE SMOKE COMING OUT OF THE LENS DELIVERY SYSTEM UNDER THE MICROSCOPE. LENS WAS ABLE TO BE IMPLANTED BUT IT TOOK A LOT OF MANEUVERING BEING LOST MOMENTUM BEFORE THE LENS WAS ABLE TO BE FULLY INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN THE SURGEON¿S OPINION, BROKEN CO2 CANNISTER CAUSED OR CONTRIBUTED TO THE EVENT. THE LENS WAS LEFT IMPLANTED WITH NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520265 ↗