Clareon PanOptix Pro PXCAT0 (REF PXCAT0.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658490317), received between Jul 17, 2025 and Apr 24, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AFTER LENS IMPLANTED AND CLINICAL REASON FOR EXPLANT BEING DOCTOR SUGGESTED TO DO AN EXCHANGE WITH AN LRI. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 24979962 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT WAS DISSATISFIED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAD BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

  Patient problems: Insufficient Information

  MAUDE report 24343687 ↗
• InjuryDec 2, 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 DIFFERENT LENS MODEL BUT HALF A DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. THE PATIENT'S ISSUES WAS RESOLVED AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. IN SURGEON¿S PROGNOSIS PATIENT CONDITION WAS GOOD.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23690457 ↗
• InjuryJul 17, 2025Material Deformation; Material Deformation

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE PATIENT HAD SOME FLOPPINESS TO THE IRIS AND IT WAS NOT DILATED WIDELY. BECAUSE OF THIS SURGEON COULD NOT INSERT THE TIP AS FAR INTO THE EYE AND SO MUCH PRESSURE WAS NEEDED TO KEEP THE TIP FROM BACKING OUT, THERE WAS SOME CHAMBER SHALLOWING AND THE INJECTION OF THE LENS TRAUMATIZED THE IRIS, SO THE PATIENT HAD AN IRIS DEFECT AND HYPHEMA. SCHEDULED PROCEDURE WAS COMPLETED THE SAME DAY AND THE LENS LEFT IMPLANTED. IN THE SURGEON¿S OPINION, CARTRIDGE TIP WAS TOO SHORT AND CANNOT BE INSERTED FAR ENOUGH INTO THE AC (ANTERIOR CHAMBER) IT CAUSED OR CONTRIBUTED TO THE EVENT. IN THE SURGEON¿S PROGNOSIS, THE PATIENT WAS SEEING WELL, BUT HAVE IRIS DEFECT AND IT WAS PERMANENT.

  Patient problems: Eye Injury; Hyphema; Iritis; Red Eye(s)

  MAUDE report 22531606 ↗