Clareon PanOptix Pro PXCAT0 (REF PXCAT0.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380658490355), received between Oct 28, 2025 and Jul 27, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A non health care professional reported that following an intraocular lens (IOL) implant procedure, the patient had intolerable glare and halos at night. Clinical reason being mentioned as multifocality. The IOL was explanted and exchanged with an unspecified ATIOL (advanced technology intraocular lens) in the secondary implant procedure.Additional information was requested and received, stating that in the surgeon's opinion, the product was the cause of the issue. There was no further impact to the patient.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 50019830 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON FOR WAS OTHER MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED FOR REPLACEMENT ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 03 MONTHS 03 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 25563611 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED THAT COULD NOT SEE. THE CLINICAL REASON WAS REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS(ATIOL) 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Impairment

  MAUDE report 25562273 ↗
• MalfunctionJun 4, 2026Device Difficult to Setup or Prepare

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE HAPTIC CAME OUT STRAIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE WAS NOTICE DURING LOADING WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393403 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC WAS OUT AND UPSIDE DOWN TRAILING HAPTIC WAS BROKEN OFF. THE SURGERY WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24663524 ↗
• InjuryJan 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 HALOS AND RINGS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN VIVITY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24093164 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLACK SHADOW OF LENS, AND LENS WAS EXPLANTED 1 MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23848998 ↗
• MalfunctionNov 18, 2025Failure to Advance; Failure to Advance

  A FACILITY REPRESENTATIVE REPORTED AN UNSPECIFIED ISSUE. AS PER IMAGE, IT APPEARS TO BE PLUNGER APPEARS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23578993 ↗
• InjuryOct 28, 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 WITH BLURRY INTERMEDIATE/NEAR VISION IN LEFT EYE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 22 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS TARGET MISSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23401957 ↗