Clareon CNA0T4 (REF CNA0T4.135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652399227), received between Jul 16, 2024 and Apr 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS CURRENTLY UNKNOWN WHETHER THESE FINDINGS WERE DISAPPEARED OR CONTINUING. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. THE LENS REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 192 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925854 ↗
• MalfunctionJul 16, 2024Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT THE LENS HAD BECOME CLOUDY ONLY IN THE UPPER PART, SINCE THE DAY AFTER SURGERY. THE SAMPLE WAS NOT AVAILABLE SINCE IT WAS STILL IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT MEMBRANE TREATMENT PROCEDURE WAS PERFORMED COMBINED WITH THE CATARACT SURGERY DURING THE INITIAL SURGERY BUT NO GAS OR OIL WAS USED. THE SIZE OF THE CCC WAS LARGER THAN THE PUPIL AND CCC WAS NOT CONFIRMED IN THE PHOTOGRAPH. VISION WAS NOT BAD AS THE CLOUDING DOES NOT AFFECT THE PUPIL AREA. THERE WERE NO PLANS TO REPLACE OF IOL OR CLEAN. DOCTOR'S OPINION: WHEN VIEWED FROM THE FRONT, IT WAS NOT AS CLOUDY AS IT APPEARS IN THE PHOTOGRAPH, AND THE IOL WAS CLOUDED LIKE A RAINBOW ON THE OUTSIDE OF THE LENS. IT SHINES A LITTLE DIMLY, AS IF IT WERE COATED WITH OIL. A CHEMICAL REACTION DUE TO CONTACT WITH THE OIL OR LUBRICANT IN THE CARTRIDGE, FRICTION, CO2, ETC. MAY HAVE OCCURRED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE FINDINGS OF IOL APPEAR TO HAVE FADED SLIGHTLY ONE WEEK LATER THAN THE DAY AFTER THE SURGERY (IMPROVING). THE PATIENT'S VISION WAS NOT AFFECTED AS OF TODAY, BUT THE DOCTOR SEEMS TO BE CONCERNED WHEN OBSERVING WITH A S

  Patient problems: Insufficient Information

  MAUDE report 19748731 ↗