Clareon PanOptix Pro PXYAT3 (REF PXYAT3.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658494278), received between Apr 7, 2026 and Jun 30, 2026 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC JAMMED BETWEEN PLUNGER AND CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS INJECTED INTO THE EYE BEFORE IT BECAME APPARENT THAT THE TRAILING HAPTIC WAS JAMMED. THE LENS WAS EVENTUALLY FREED FROM THE INJECTOR AND PLACED IN THE CAPSULAR BAG. IT WAS NOT REMOVED FROM THE EYE. THERE WAS MORE WOUND AND OCULAR MANIPULATION THAN NECESSARY, PROLONGING SURGERY AND LIKELY CAUSING INCREASED INFLAMMATION AND SLOWER RECOVERY, THOUGH THE PATIENT CONTINUES TO RECOVER WITHOUT LONG-TERM COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 25663583 ↗
• MalfunctionApr 7, 2026Scratched Material

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PRELOADED LENS HAD BEEN SCRATCHED, AND THE INITIAL PROCEDURE HAD BEEN COMPLETED ON THE SAME DAY, NO PATIENT CONTACT OCCURRED. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS INSERTED IN THE NORMAL WAY. UPON VIEWING THE LENS, A SUPERFICIAL SCRATCH WAS NOTED ACROSS THE CENTER OF THE LENS. THE SURGEON CHECKED WITH THE I/A HANDPIECE TO MAKE SURE IT WASN'T JUST LOOSE VISCOELASTIC, BUT IT WAS INDEED A SCRATCHED LENS. IT WAS THEN CUT, REMOVED, AND A COMPANY LENS OF SAME MODEL BUT HALF DIOPTER MORE POWER WAS INSERTED WITHOUT ISSUE IN AN INITIAL PROCEDURE. THE SURGEON STATED THAT THEY WERE UNSURE WHAT CAUSED THE ISSUE, IT COULD BE EITHER A DEFECT WHEN THE LENS WAS MADE OR, MORE LIKELY, AS IT WAS INSERTED, IT RUBBED AGAINST A COMPONENT IN THE INSERTER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799797 ↗