Clareon PanOptix Pro PXCAT5 (REF PXCAT5.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658492274), received between Jul 17, 2026 and Aug 18, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that after the intraocular lens (IOL) implantation surgery, the patient's vision was nearly always wavery, 4 months after initial implantation surgery, the patient was told that it may improve. It was very distracting and distressing for the patient. The patient's medium and distant vision was not clear or distinct. Even now with a new prescription for glasses, the patient could not read road signs. The patient could see blobs of color in the field, although the patient knew they are flowers, but couldn't identify them, until standing next to them. The patient could not read a menu posted on a board unless directly underneath it. However, the patient's vision is 20/20. The patient is now using new glasses, and eye drops several times a day.Additional information was received stating that the patient experienced halo/glare street lights & headlights had multiple rings, metal jewelry in the daylight glows with halos making it difficult to put on a bracelet, need sunglasses outside because the light was uncomfortably bright. The patient also experienced dry eye post-operatively.There are two Medical Device Reports associated with this patient. T

  Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 50300296 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASE IN VISION, HAZY, BLURRY, P. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE PSEUDOPHAKIA, COMPLICATION OF IOL/ ANISOMETROPIA. THE IOL WAS REPLACED WITH UNSPECIFIED LENS 6MONTHS 26 DAYS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 25855608 ↗