Clareon PanOptix Pro PXCAT3 (REF PXCAT3.280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658491482), received between Apr 24, 2026 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 reports).

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.

• MalfunctionSep 25, 2026Failure to Advance

  A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon had an issue with two injectors on the same case. Both the devices were inoperable, so the surgeon manually loaded the second IOL and completed the surgery.Additional information has been received and stated, the plunger was pushed past the lens during the lens insertion into the eye and in surgeon¿s opinion this contributed to or caused the event. The procedure was completed on the same day and the second lens still remains implanted. There was no harm or complication to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894799 ↗
• MalfunctionSep 25, 2026Failure to Advance

  A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon had an issue with two injectors on the same case. Both the devices were inoperable, so the surgeon manually loaded the second IOL and completed the surgery.Additional information has been received and stated, the plunger was pushed past the lens during the lens insertion into the eye and in surgeon¿s opinion this contributed to or caused the event. The procedure was completed on the same day and the second lens still remains implanted. There was no harm or complication to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894798 ↗
• MalfunctionApr 24, 2026Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE INJECTOR WAS BENT WHILE ADVANCING THE LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984953 ↗