Clareon PanOptix Pro PXCAT3 (REF PXCAT3.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380658491383), received between Sep 17, 2025 and Sep 14, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Insufficient Device Problem Information

  A Nurse reported that following the cataract surgery with intraocular lens (IOL) implant procedure the patient experienced Blurred vision. The lens had been exchanged in a secondary procedure. Clinical reason for the explant was refractive surprise despite use of ORA.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50758599 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED REFRACTIVE ERROR. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Impairment

  MAUDE report 25892463 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT REPORTED REPORTED WAXY VISION AND A LAZY EYE IN THE RIGHT EYE (OD), ALONG WITH ASSOCIATED LIGHT SENSITIVITY. VISION WAS DESCRIBED AS FOGGY AND HAZY, AND THESE SYMPTOMS HAD BEEN PRESENT SINCE SURGERY. THE PATIENT ALSO NOTED PERSISTENT FLOATERS FOLLOWING SURGERY AND EXPERIENCED DIFFICULTY READING SMALLER PRINT, WITH MINIMAL IMPROVEMENT IN NEAR VISION, WHILE DISTANCE VISION REMAINED RELATIVELY GOOD. SYMPTOMS HAD BEEN GRADUALLY WORSENING OVER TIME AND WERE MOST NOTICEABLE DURING NEAR TASKS SUCH AS READING AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 25575381 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED EXCESSIVE HALOS. THE IOL HAS BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MALADAPTATION AND NEGATIVE DYSPHOTOPSIA.

  Patient problems: Visual Disturbances

  MAUDE report 25043953 ↗
• MalfunctionNov 24, 2025Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, WAS INSERTING THE LENS, THE TRAILING HAPTIC WAS STUCK ON THE INJECTOR. THEY REVISED THE TIP OF THE INJECTOR AND NOTICED THAT IT WAS BENT AND DEFECTIVE. NO HARM TO PATIENT AND CASE STILL WENT WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE COMPLETED ON THE SAME DAY WITH NEW LENS. THE SURGEON PROGNOSIS STATED THAT PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632354 ↗
• MalfunctionSep 17, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING THE LENS INTO THE EYE THAT THE TAIL HAPTIC DID NOT COME OFF THE INJECTOR. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED THE SAME DAY WITH ANOTHER LENS AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074786 ↗