Clareon™ CNA0T0 (REF CNA0T0.140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652393591), received between Jan 6, 2022 and Apr 24, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (4 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HIS VISION WAS NOT AS GOOD AS HE THOUGHT IT WOULD BE. HIS SURGEON HAD SAID HE WOULD SEE WELL AT A DISTANCE AND WOULD BE ABLE TO DRIVE WITHOUT GLASSES. HOWEVER, HE COULD ONLY SEE CLEARLY UP TO ABOUT 10 FEET, AFTER WHICH HIS VISION BECAME BLURRY. THIS WAS NOT WHAT HE HAD EXPECTED. ADDITIONALLY, THE DAY AFTER SURGERY, HE WAS SEEN AT HIS FIRST POSTOPERATIVE VISIT AND WAS FOUND TO HAVE AN ELEVATED IOP (INTRAOCULAR PRESSURE) OF 37¿40. THE SURGEON PERFORMED A PRESSURE TAP WITH A NEEDLE TO LOWER THE PRESSURE. SHE THEN PRESCRIBED A STEROIDAL ANTI-INFLAMMATORY EYE DROP TO BE USED FOUR TIMES DAILY (QID). THE STEROID EYE DROP CAUSED HIM EXTREME HEAD PAIN, PROMPTING HIM TO RETURN TO THE EYE SURGEON. AT THAT VISIT, HIS IOP HAD INCREASED TO 50, AND THE SURGEON PERFORMED ANOTHER NEEDLE TAP TO LOWER THE PRESSURE, BRINGING IT DOWN TO 10. SHE PRESCRIBED A CARBONIC ANHYDRASE INHIBITOR AND AN ALPHA-ADRENERGIC AGONIST TO BE USED TWICE DAILY (BID). HE WAS SEEN AGAIN AND WAS FOUND TO STILL HAVE INFLAMMATION IN THE EYE. THE SURGEON RESTARTED THE STEROID EYE DROP AND INSTRUCTED HIM TO USE IT IN A WEEKLY TAP

  Patient problems: Blurred Vision; Inflammation; Intraocular Pressure Increased

  MAUDE report 24983759 ↗
• MalfunctionFeb 18, 2026Failure to Fold

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE LENS WAS NOT IMPLANTED AS IT DID NOT LOAD PROPERLY. THE LENS WAS DISPOSED ACCIDENTALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24385087 ↗
• MalfunctionDec 17, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  A NURSE REPORTED THAT DURING A CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DAMAGED PLUNGER (COMPANY INJECTOR) SCRATCHED THE LENS PERIPHERY AND THE PATIENT'S ENDOTHELIUM WHILE IMPLANTING THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Corneal Endothelial Cell Loss

  MAUDE report 23827353 ↗
• MalfunctionMay 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH LENS IMPLANT, THEY NOTICED THAT THE HAPTICS OF THE LENS WAS STUCK ON THE INJECTOR WHILE PUTTING THE LENS TO THE PATIENT'S EYE. THE SURGERY WAS COMPLETED WITH A NEW LENS WITH THE SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21994381 ↗
• MalfunctionMar 14, 2025Break; Failure to Advance; Break; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN CLEANING AND STERILIZATION OF INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL BECAME STUCK IN THE CARTRIDGE, CAUSING THE HAPTIC TO BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604300 ↗
• MalfunctionSep 26, 2024Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WOULD NOT DEPLOY PROPERLY AND ANOTHER LENS WAS OPENED TO USE IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20309247 ↗
• MalfunctionJul 29, 2024Defective Device; Failure to Eject; Defective Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS STICKED TO PLUNGER AND CARTRIDGE IS SEPARATED FROM DEVICE. SURGERY WAS COMPLETED BY USING OTHER LENS AND THERE IS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849591 ↗
• MalfunctionMar 4, 2024Failure to Eject; Failure to Eject

  A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IOL WAS STUCK INSIDE THE DEVICE DURING DELIVERY. SURGERY WAS COMPLETED USING ANOTHER UNSPECIFIED REPLACEMENT IOL WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826983 ↗
• MalfunctionDec 27, 2022Defective Device; Defective Device

  AN ADMINISTRATOR REPORTED THAT A LENS WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 16051546 ↗
• MalfunctionJul 25, 2022Break; Failure to Eject; Break; Failure to Eject

  A PHARMACIST REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), WHILE INJECTING THE LENS STUCK IN THE INCISION SITE. THE HAPTICS BROKE WHEN REMOVING THE LENS. THE SURGERY WAS COMPLETED WITH THE SAME POWER AND MODEL BACK UP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092776 ↗
• MalfunctionJan 6, 2022Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CREASE OR SCRATCH ON THE POSTERIOR SIDE OF LENS POST IMPLANT. SURGEON BISECTED THE LENS AND REMOVED IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174779 ↗