Clareon PanOptix Pro PXCAT0 (REF PXCAT0.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380658490379), received between Sep 17, 2025 and Aug 25, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  A non health professional reported that following surgery, the patient experienced poor vision. The clinical reason for explant was poor vision. The IOL was replaced with an advanced technology intraocular lens (ATIOL). As a result, the intraocular lens (IOL) was explanted 4 months, 4 days, after the initial implant procedure. Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision

  MAUDE report 50435563 ↗
• MalfunctionJul 10, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS FOLDED AT THE BOTTOM OF THE LENS INSTEAD OF ON TOP. THE LENS WAS HALFWAY IN WHEN THE SURGEON NOTICED THIS, AFTER WHICH THE LENS WAS PULLED OUT USING A 0.12 FORCEPS. THERE WAS NO PATIENT HARM. 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 25776780 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR DISTANCE VISION. CLINICAL REASON AS POOR VISION QUALITY. THE IOL WAS EXCHANGED FOR MONOFOCAL IOL 4 MONTHS 1 WEEK 4 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 25333657 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT RESULT WAS NOT GOOD. THE LENS WAS EXCHANGED FOR ANOTHER COMPANY LENS 04 MONTHS 06 DAYS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24937862 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND COLOR NOT VIVID, HALOS AND BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER COMPANY LENS. CLINICAL REASON FOR THE EXPLANT IS IOL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24332983 ↗
• 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 24234863 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE LENS WAS EXCHANGED WITH NONCOMPANY LENS AND PATIENT EXPERIENCED WITH POOR DISTANCE AND NEAR VISION. IN SURGEON'S OPINION PRODUCT WAS NOT CONTRIBUTED TO THE OPINION. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23931414 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 23907122 ↗
• MalfunctionSep 17, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION TRAILING HAPTIC GOT STUCK ON THE INJECTOR WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER UNSPECIFIED BACKUP LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074789 ↗