Clareon CNA0T3 (REF CNA0T3.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652398817), received between Jul 23, 2024 and Oct 31, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Failure to Fold; Failure to Fold

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT; THE SURGEON HANDLED AN INJECTOR INCORRECTLY. HE ADVANCED THE PLUNGER TOO FAR AND DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A COMPANY IOL.

  Patient problems: Insufficient Information

  MAUDE report 23435754 ↗
• InjurySep 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 7 DAYS POST-OPERATION THE SURGEON NOTICED THAT THE LENS WAS ROTATED 60 DEGREES. THE SURGEON REPOSITIONED THE LENS IN THE OPERATION THEATRE 36 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE SURGEON CHECKED THE LENS AFTER RE-ROTATION AND NOTICED THAT IT HAD ONCE AGAIN ROTATED (85 DEGREES INSTEAD OF 110). THE SURGEON SUSPECTED THERE WAS AN ODD HAPTIC. HE PLANNED TO REVIEW THE PATIENT IN 3 MONTHS AND POSSIBLY PERFORM A TOP-UP LASER. SURGEON DID NOT WANT TO GO INTO THE EYE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 23092882 ↗
• MalfunctionSep 12, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY THE HAPTIC BENT/CRIMPED/DISTORTED/TWISTED AND TRAILING HAPTIC FOLDED WRONG. EVENT OCCURED PRE-ADVANCEMENT OF THE LENS BEFORE INJECTION INTO THE EYE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039332 ↗
• MalfunctionAug 21, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT ADVANCE. THERE WAS A PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22869910 ↗
• 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 152 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929502 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY AFTER THE LENS WAS IMPLANTED. 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 217 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928609 ↗
• 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 42 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925844 ↗
• 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 62 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925547 ↗
• 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. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 96 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925327 ↗
• MalfunctionMar 14, 2025Product Quality Problem; Product Quality Problem

  HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE DEVICE WAS DEFECTIVE, AND STATED THAT BACK UP IOL WAS USED AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606487 ↗
• MalfunctionMar 10, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER DID NOT PICK UP THE LENS AND THE LENS WAS REMOVED MANUALLY. LENS WAS IMPLANTED USING AN UNSPECIFIED CARTRIDGE AND COMPANY INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21558874 ↗
• MalfunctionJul 23, 2024Defective Device; Defective Device

  A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED A PLACEMENT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19805819 ↗