Clareon PanOptix Pro PXCAT3 (REF PXCAT3.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380658491314), received between Sep 19, 2025 and Jul 28, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced difficulty in seeing distance. The lens was exchanged for another lens model 02 months 11 days following the initial procedure. Clinical reason for explant was mentioned as blurry vision.Additional information was received and stated, the lens was exchanged with non-company lens.

  Patient problems: Blurred Vision

  MAUDE report 50054545 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THE QUALITY OF VISION DESPITE GOOD OBJECTIVE SNELLEN VISUAL ACUITY, WITH INTRAOPERATIVE FLOPPY IRIS SYNDROME (IFIS) CAUSING IRIS ATROPHY AND PHOTOPHOBIA THOUGH HE FUNCTIONED OUTDOORS WITH SUNGLASSES, AND SHADING TEMPORAL LIGHT MADE NO DIFFERENCE; THERE WAS NO SIGNIFICANT REFRACTIVE ERROR, OPTICAL PATH DIFFERENCE (OPD) SCAN SHOWED A NORMAL CORNEAL SURFACE, AND OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED NO RETINAL EDEMA, HE WAS NOT EXPECTED TO BE HAPPY WITH A MULTIFOCAL IOL (MIOL). IN THE FUTURE AN IOL XC WAS RECOMMENDED AND IT WAS DISCUSSED THAT THIS WOULD BE A DELICATE PROCEDURE TO TRY TO AVOID FURTHER IRIS DAMAGE, WITH PHOTOPHOBIA TO BE REASSESSED AFTERWARD AND IRIS SUTURES CONSIDERED IF IT AFFECTED FUNCTIONING; THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS AND 11 DAYS FOLLOWING THE INITIAL PROCEDURE. IN SURGEON'S OPINION PRODUCT WAS NOT CONTRIBUTED TO THE EVENT BUT IT WAS PATIENT DISSATISFACTION. THERE WAS NO FURTHER HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment

  MAUDE report 24172927 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY AT ALL RANGES. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA AND ANISOMETROPIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23646584 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAD PCO (POSTERIOR CAPSULAR OPACIFICATION) LOCATED CENTRALLY AND WAS IMPACTING THE VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE VISION WAS BLURRED BECAUSE OF PCO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 23322105 ↗
• MalfunctionSep 19, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD A DARK MARK ON THE LENS. IT WAS LEFT IN THE PATIENT EYE AS THE SURGEON DECIDED IT WAS NOT GOING TO AFFECT VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23094401 ↗