Clareon CNA0T4 (REF CNA0T4.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652399401), received between Mar 14, 2025 and Sep 28, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fold

  A Nonhealthcare professional reported with description of lens did not unload properly.Additional information has been requested, yet no new information received.

  Patient problems: Insufficient Information

  MAUDE report 50916283 ↗
• MalfunctionSep 16, 2026Device Difficult to Setup or Prepare

  A physician reported that during the setting, the trailing haptic of the lens was extended as the lens was advanced with no patient contact. Surgery was completed by replacing with the same product.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791239 ↗
• MalfunctionJul 22, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904162 ↗
• MalfunctionJul 22, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 25902192 ↗
• MalfunctionApr 17, 2026Failure to Deliver; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING AND TRAILING HAPTICS WERE NOT TUCKED AND BECAME STUCK IN THE INJECTOR WHEN ATTEMPTING TO IMPLANT THE LENS INTO THE EYE. THE LENS WAS REMOVED AND ANOTHER UNSPECIFIED LENS WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. THE LENS WAS DISCARDED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911456 ↗
• MalfunctionNov 27, 2025Inaccurate Delivery; Inaccurate Delivery

  LENS BACKED OUT FROM INCISION HALFWAY INTO INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 23669083 ↗
• MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRUMPLED OR FAULTY LENS WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS WAS INSERTED INTO THE CAPSULE AND THEN REMOVED BECAUSE OF ITS APPEARANCE DURING THE INITIAL PROCEDURE. SURGERY WAS COMPLETED BY USING ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278719 ↗
• MalfunctionAug 12, 2025Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. NO PATIENT AFFECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784914 ↗
• MalfunctionApr 18, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FAULTY AND NOT USED. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS WAS FAULTY BECAUSE THE LENS EXTRACTED TOO FAST AND THE LENS WAS HALF WAY OUT OF THE CARTRIDGE BEFORE THE SURGEON EVEN HAD A CHANCE TO INSERT INTO THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 21864141 ↗
• MalfunctionMar 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A PHARMACIST REPORTED THAT NOTICED A PLACEMENT FAILURE WITH THE IMPLANT. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21683179 ↗
• MalfunctionMar 14, 2025Failure to Fold; Device Difficult to Setup or Prepare; Failure to Fold; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A LEADING HAPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING A CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE DEVICE FAILED TO FOLD LENS CORRECTLY AND WAS NOT IMPLANTED. THEIR WAS NO PATIENT INVOLVEMENT AND IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606666 ↗