Clareon PanOptix Pro PXCAT0 (REF PXCAT0.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380658490324), received between Nov 24, 2025 and Sep 1, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50543019 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  A non health professional reported that following surgery, the patient experienced blurry visual acuity (VA), dysphotopsia left eye (OS). The clinical reason for explant was dysphotopsia. The IOL was replaced with an another company lens. As a result, the intraocular lens (IOL) was explanted 4 months, 4 days after the initial implant procedure.There are two medical reports associated with this patient. This file belongs to left eye.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50175750 ↗
• MalfunctionFeb 12, 2026Material Twisted/Bent

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BENT WHILE LOADING. THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322343 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED EXPERIENCING LARGE HALOS AROUND HEADLIGHTS BOTH DURING DAY AND NIGHT FOLLOWING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL). THIS DISTORTION WAS CAUSING UNACCEPTABLE INTERFERENCE WITH SAFE DRIVING, ESPECIALLY AT NIGHT. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE PATIENT BEGAN EXPERIENCING SYMPTOMS IMMEDIATELY FOLLOWING CATARACT SURGERY. SHE DISCUSSED THESE CONCERNS WITH THE SURGEON, WHO ADVISED THAT THE SYMPTOMS MIGHT IMPROVE AFTER SIX MONTHS. THE PATIENT REPORTED THAT HER DISTANCE VISION WAS NOT PERFECTLY CORRECTED, PROMPTING HER TO CONSULT AN EYE CARE SPECIALIST FOR A NEW PRESCRIPTION. THE NEW GLASSES RESULTED IN EXCELLENT DISTANCE VISION, WHILE HALOS AROUND THE LIGHTS WERE ONLY SLIGHTLY CHANGED. 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 23630436 ↗