Clareon PanOptix Pro PXCAT3 (REF PXCAT3.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658491253), received between Feb 12, 2026 and Mar 13, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS REPLACED WITH COMPANY SAME LENS MODEL BUT ONE DIOPTER LESS POWER. WHEN PATIENT FIRST GOT THE LENS IMPLANTED, THEY HAD DIFFICULTY FINDING GOLF BALLS ON THE COURSES, AND DIFFICULTY READING STREET AND HIGHWAY SIGNS. IT TURNED OUT THAT RIGHT LENS WAS NOT THE CORRECT DISTANCE, SO IT WAS RE-IMPLANTED. WHICH WAS BETTER FOR DISTANCE BUT NOT AS GOOD FOR NEAR VISION. NOW PATIENT NEED GLASSES TO SEE CLEARLY. THE LENS SEES BETTER FOR DISTANCE BUT THAT DIMINISHES THE CLOSE VISION.

  Patient problems: Blurred Vision

  MAUDE report 24594454 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED OUTCOME. THE PATIENT HAD GHOSTING, HALOS AND BLURRY VISION CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS IOL COMPLICATIONS. THE LENS WAS EXPLANTED AND EXCHANGED WITH COMPANY MODEL LENS FOLLOWING THE INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24324983 ↗