Clareon CNA0T3 (REF CNA0T3.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652398794), received between Mar 28, 2025 and Jul 20, 2026 — classified as 11 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 16, 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.

• MalfunctionJul 20, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25875875 ↗
• MalfunctionApr 10, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC STRAIGHT AND STUCK IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24845316 ↗
• MalfunctionApr 10, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC STRAIGHT AND STUCK IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24839637 ↗
• MalfunctionNov 28, 2025Device Damaged Prior to Use; Failure to Advance; Device Damaged Prior to Use; Failure to Advance

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR SEEMED NON-COMPLIANT UPON INITIAL OPENING, PLUNGER OVERRIDE. THE SURGERY WAS COMPLETED THE SAME DAY AFTER REPLACING WITH ANOTHER INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23671938 ↗
• MalfunctionNov 24, 2025Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT CATCH THE EDGE OF THE OPTIC AND WENT UNDER THE IOL NOT INITIATING THE FOLDING. THE PROCEDURE WAS COMPLETED BY USING THE BACKUP LENS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631062 ↗
• MalfunctionNov 17, 2025Failure to Deliver; Failure to Deliver

  A PHARMACIST REPORTED WITH A DESCRIPTION OF LENS WAS STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23577270 ↗
• MalfunctionOct 22, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS DID NOT UNFOLD PROPERLY WHILE BEING INSERTED INTO THE PATIENT'S EYE. THERE WAS NO HARM TO THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359630 ↗
• MalfunctionApr 30, 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 WAS STILL IN PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933374 ↗
• 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 222 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926553 ↗
• 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 16 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925449 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, TRAILING HAPTIC WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, SURGERY WENT WELL USING THE BACK-UP PRELOADED COMPANY IOL WITHOUT CAUSING ANY HARM TO THE PATIENT. THE PRIMARY LENS WITH THE BENT TRAILING HAPTIC OCCURRENCE NOTED DURING ADVANCEMENT OF THE LENS BY THE SURGEON PRIOR TO IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721555 ↗