Clareon CNW0T3 (UDI 00380652409674)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652409674), received between Jun 18, 2024 and Aug 26, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Product Quality Problem

  A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, a defect in the lens was detected. Additional information was received indicating that the lens was replaced with a company lens. There was no patient contact, and no further impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449984 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  A non health care professional reported that during an intraocular lens (IOL) implant procedure, the patient experienced visual disturbance, blurry vision. The IOL was explanted and exchanged for an unknown advanced technology intraocular lens (ATIOL) 2 months, 2 days following the initial implant procedure.Additional information received and the file was updated accordingly.

  Patient problems: Visual Impairment

  MAUDE report 50082144 ↗
• MalfunctionMay 29, 2026Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT THE BACK HAPTIC WOULD NOT FOLD. THE ISSUE WAS NOTED DURING LOADING AND THERE WAS NO PATIENT CONTACT. IN THE SURGEONS OPINION, BAD HAPTIC CAUSED OR CONTRIBUTED TO THE EVENT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333656 ↗
• MalfunctionApr 22, 2026Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE EYE WITH THE INJECTOR SET AS USUAL, AND THE IOL WAS CONFIRMED TO BE DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 24955526 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH UNABLE TO TOLERATE BLURRINESS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 17 DAYS FOLLOWING THE INITIAL PROCEDURE. THE LENS WAS REPLACED WITH NONCOMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23919240 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS NOT ABLE TO READ. THE LENS WAS EXPLANTED AND EXCHANGED 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22716837 ↗
• InjuryApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND IT HAS BEEN DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A INTRAOCULAR LENS.

  Patient problems: Visual Impairment

  MAUDE report 21755746 ↗
• MalfunctionOct 29, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING THE LENS GOT STUCK IN CARTRIDGE AND CRACKED. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. AS PER SURGEON THE PRODUCT DID NOT CONTRIBUTE TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558518 ↗
• MalfunctionSep 21, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF, SCRATCH-LIKE OBSERVATION WAS FOUND ON THE OPTICAL PART. THERE WAS NO VISION PROBLEMS OR HEALTH PROBLEMS. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275008 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THE TEARS/CRACKS IN THE IOL AFTER IMPLANTATION AND THIS HAS TWO CRACKS IN THE PERIPHERY. THE IOL REMAINED IN THE EYE. NO COMPLICATIONS ARE EXPECTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559007 ↗