Clareon PanOptix Pro PXCAT4 (REF PXCAT4.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658491741), received between Oct 15, 2025 and Oct 28, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH HALOS AND GLARE IN BOTH EYES, HEADACHES, AND BLURRED VISION. AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH A COMPANY LENS (T4.160) LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE PATIENT HAD DECLINED VISION CORRECTION PROCEDURES SUCH AS LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) AND PHOTOREFRACTIVE KERATECTOMY (PRK). THE COMPANY LENS (T4.160) WAS ADJUSTED WITH A POWER OF MINUS 1.00 TO TARGET MORE HYPEROPIA. THE SURGERY WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 23401149 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HALOS/GLARE AND BLURRY VISUAL ACUITY. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL LENS 02 MONTHS 08 DAYS IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. 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 23321977 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HALOS/GLARE AND BLURRY VISUAL ACUITY. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 08 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23300767 ↗