Clareon PanOptix Pro PXCAT0 (REF PXCAT0.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658490393), received between Oct 22, 2025 and Mar 30, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED TOO SEVER GLARE AND HALOS AT NIGHT. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXCHANGE WAS VISUAL ADVERSE EVENT DUE TO DIFFRACTIVE OPTIC. ADDITIONAL INFORMATION RECEIVED AND THE SURGEON REPORTED UNABLE TO ACHIEVE ACUITY IMPROVEMENT AT ANY REFRACTIVE POWER.

  Patient problems: Visual Disturbances

  MAUDE report 24713442 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SHADOWING IN VISION AND CLINICAL REASON FOR EXPLANT BEING DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23907666 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING CATARACT SURGERY, 5 MONTHS LATER, SHE HAS BEEN SUFFERING WITH THE RESULT OF THE SURGERY. THE DISTANCE VISION WAS NOT CLEAR, SHE NEEDED TO WEAR EYEGLASSES OR CONTACT LENS, OTHERWISE SHE EXPERIENCED VERY BAD EYE STRAIN AND HEADACHES. MOREOVER, THE QUALITY OF UP-CLOSE VISION WAS VERY TERRIBLE WITH SHADOWS, GHOSTING AND SMEARING. SHE FURTHER NEEDED READING GLASSES FOR READING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances

  MAUDE report 23605978 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TRIPLE VISION AND BLURRINESS CAUSING BALANCE ISSUES AND DIFFICULTY IN PERFORMING DAILY ACTIVITIES. SURGEON SAID THAT THE PATIENT HAD DRY EYES AND IT WAS TREATED WITH DROPS AND OINTMENTS WHICH DID NOT HELP. SO, THE PATIENT HAD A SECOND OPINION AND THE LENS WAS EXCHANGED WITH ANOTHER LENS IN THE SECONDARY IMPLANT PROCEDURE. AFTER EXCHANGE THE PATIENT VISION HAS IMPROVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 23358532 ↗