Clareon PanOptix Pro PXCAT3 (REF PXCAT3.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658491277), received between Dec 3, 2025 and Apr 9, 2026 — classified as 3 injuries, 1 malfunction.

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

• MalfunctionApr 9, 2026Break

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE DURING THE INTRAOCULAR (IOL) LENS IMPLANT PROCEDURE HAPTIC WAS SHEARED OFF AND DID NOT COME OUT OF THE CARTRIDGE CORRECTLY. THERE WAS A PATIENT CONTACT WITH THE DEVICE AND PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE TIP OF THE PRE-LOADED DEVICE WAS IN CONTACT WITH THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24834577 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT STILL NOT SEEING WELL, ESPECIALLY UP CLOSE. IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO THE EVENT. PATIENT WAS STILL UNSATISFIED WITH CLARITY OF VISION POST IOL EXCHANGE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24590693 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GHOSTING, HALOS AND BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD NEAR AND INTERMEDIATE BLURRY VISION. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24303990 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD LARGE HALOS AROUND HEADLIGHTS, BOTH NIGHT AND DAY, INTERFERING WITH SAFE DRIVING IMMEDIATELY AFTER CATARACT SURGERY. SURGEON SUGGESTED THAT AFTER SIX MONTHS, THE EFFECT MIGHT IMPROVE. THE DISTANCE VISION WAS NOT PERFECTLY CORRECTED, SO THE PATIENT SAW AN EYE CARE DOCTOR FOR A NEW PRESCRIPTION. THE NEW GLASSES RESULTED IN EXCELLENT DISTANCE VISION. HALOS ONLY SLIGHTLY CHANGED AND ARE STILL PROMINENT AROUND HEADLIGHTS AND OTHER LIGHTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23705732 ↗