Clareon CNA0T4 (REF CNA0T4.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652399364), received between Oct 29, 2024 and Apr 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS SCRATCHED IN THE DELIVERY SYSTEM DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING BACK UP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911279 ↗
• MalfunctionAug 8, 2025Inaccurate Delivery; Inaccurate Delivery

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LEVER WAS PRESSED DOWN ON THE COMPANY¿S PRELOADED DELIVERY SYSTEM, THE LENS KEPT ADVANCING FORWARD DESPITE FINGERS BEING LIFTED OFF. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22747245 ↗
• MalfunctionJul 4, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY BEFORE INSERTING THE IOL INTO THE EYE, THE TRAILING HAPTIC WAS STRETCHED AND SEEMED TO TEAR OFF. IT WAS DISCONTINUED DUE TO BREAKAGE DUE TO PROCEDURAL PROBLEM BY THE SURGEON. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH THE THREE-PIECE LENS BY ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402716 ↗
• 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 UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 60 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926536 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED ABOUT AN INTRAOCULAR LENS (IOL) STATING DURING PROCEDURE THERE WAS A PROBLEM WITH THE IOL COATING (THE IOL LOOKED BLUE) AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM SO FAR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926023 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED ABOUT AN INTRAOCULAR LENS (IOL) STATING DURING PROCEDURE THERE WAS A PROBLEM WITH THE IOL COATING (THE IOL LOOKED BLUE) AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM SO FAR. LENS REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925508 ↗
• MalfunctionOct 29, 2024Particulates; Scratched Material; Particulates; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY INVOLVING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH OR FOREIGN MATERIAL ADHERED TO THE SURFACE OF THE LENS AFTER IT WAS IMPLANTED. THE FOREIGN MATERIAL COULD NOT BE REMOVED BY ASPIRATION WITH THE IRRIGATION/ASPIRATION (I/A). ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556807 ↗