Clareon PanOptix Pro PXYAT0 (REF PXYAT0.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658493301), received between Jan 30, 2026 and May 22, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC GOT CAUGHT AND LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25257084 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER CALLED TO REPORT SHE WAS HAVING EXTREME HALOS AT NIGHT, CAUSING DIFFICULTY IN DRIVING AND HAVING SHADOWS BEHIND LETTERS WHEN TRYING TO READ. DISTANCE VISION DURING THE DAY WAS GOOD. HAD SPOKEN TO HER SURGEON, HE HAD TREATED FOR DRY EYE AND DETERMINED SHE DID NOT HAVE DRY EYE. HAD BEEN TREATED WITH A DRUG WHICH BELONGS TO THE MIOTICS TO REDUCE PUPIL SIZE WHICH HAD NOT HELPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24220845 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER CALLED TO REPORT SHE WAS HAVING EXTREME HALOS AT NIGHT, CAUSING DIFFICULTY IN DRIVING AND HAVING SHADOWS BEHIND LETTERS WHEN TRYING TO READ. DISTANCE VISION DURING THE DAY WAS GOOD. HAD SPOKEN TO HER SURGEON, HE HAD TREATED FOR DRY EYE AND DETERMINED SHE DID NOT HAVE DRY EYE. HAD BEEN TREATED WITH A DRUG WHICH BELONGS TO THE MIOTICS TO REDUCE PUPIL SIZE WHICH HAD NOT HELPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24220687 ↗