Clareon PanOptix Pro PXCAT0 (REF PXCAT0.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380658490362), received between Sep 2, 2025 and Sep 18, 2026 — classified as 6 injuries, 2 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 8 most recent of 8 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, and foggy 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, the patient was advised to allow additional time for healing. There are two Medical Device Reports associated with this patient. This report is associated with the right eye.

  Patient problems: Blurred Vision

  MAUDE report 50818037 ↗
• InjuryApr 24, 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 HALOS, GLOWS, COULD NOT SEE, BLURRY VISION AND NO COLORS. CLINICAL REASON BEING MENTIONED AS PATIENT DISSATISFACTION. THE IOL WAS EXPLANTED AND EXCHANGED WITH A WITH NON-COMPANY LENS INTRAOCULAR LENS IN THE SECONDARY IMPLANTATION PROCEDURE. PATIENT SYMPTOMS WERE RESOLVED. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO OR CAUSED THE EVENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24979146 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED, BLURRY VISION AND VISION WAS NOT GOOD. TH E LENS WAS EXPLANTED AND EXCHANGED WITH ATIOL LENS 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 24470944 ↗
• MalfunctionFeb 23, 2026Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT A HAPTIC WAS BROKEN WITH NO PATIENT CONTACT AND ISSUE WAS FOUND UPON OPENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414600 ↗
• InjuryDec 22, 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, THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED AS INTOLERANT OF MULTIFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23863652 ↗
• InjuryNov 21, 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, THE PATIENT EXPERIENCED POOR VISUAL ACUITY AT ALL DISTANCES. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT COMPANY LENS DURING A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO FURTHER IMPACT TO THE PATIENT. PATIENT REPORTED OF VISION BLURRY.

  Patient problems: Blurred Vision

  MAUDE report 23618126 ↗
• MalfunctionSep 8, 2025Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC GOT SHEARED OFF UPON DELIVERY OF THE LENS INTO THE EYE. SUBSEQUENTLY THE LENS WAS CUT OUT AND REPLACED DURING INITIAL PROCEDURE. PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22993749 ↗
• InjurySep 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 POOR DISTANCE VISION. CLINICAL REASON FOR EXPLANT WAS HYPEROPIC REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22940257 ↗