Clareon PanOptix Pro PXYAT0 (REF PXYAT0.110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658493103), received between Nov 14, 2025 and Jul 28, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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 18, 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.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced glare/halos and can't drive at night or in rainy conditions. Additional information was received that carbachol (2.75%) and brimonidine tartrate (0.1%) in combination drops were prescribed as medication to help with glare and halos. The patient returned after a few days stating the drops might have been helping a little and was given the option of an IOL exchange vs continuing to give it more time to adapt. The patient wished to give it more time and scheduled her next appointment later.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 50053648 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS DISCOMFORT IN THE VISION, SURGERY WAS COMPLETED AFTER REPLACEMENT THE SYMPTOMS WAS RESOLVED AND THERE WAS NO PROBLEM.

  Patient problems: Blurred Vision

  MAUDE report 25815769 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT VISUAL OUTCOME WAS NOT GOOD. THE LENS WAS EXPLANTED 20 DAYS FOLLOWING THE INITIAL PROCEDURE. THE LENS WAS EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT ALSO EXPERIENCED BLURRED NEAR AND FAR VISION. PATIENT ISSUES WERE RESOLVED. THE PATIENT EXCHANGED WITH NON-COMPANY LENS MODEL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24307512 ↗
• MalfunctionNov 14, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED DUE TO THE PRESENCE OF AIR BUBBLES WITHIN THE ACRYLIC. THE SURGEON HAD TO CUT THE LENS AND REPLACED IT WITH ANOTHER UNSPECIFIED LENS. THE PROCEDURE WAS TRAUMATIC TO THE PATIENT'S EYE. THE SURGEON REPORTED THAT ONE PIECE OF THE LENS CONTAINED THE BUBBLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555462 ↗