Clareon CNW0T3 (UDI 00380652402309)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652402309), received between Aug 4, 2022 and Sep 25, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Twisted/Bent

  A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, haptic would not folded on the lens during loading, with no patient contact. The procedure was completed on the same day. In the surgeon's opinion, bad haptic caused or contributed to the event. Additional information has been requested but no information is available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896022 ↗
• MalfunctionAug 31, 2026Material Twisted/Bent

  A healthcare professional reported that during intraocular lens (IOL) implantation surgery, during loading the lens in to the cartridge, the IOL haptic was found to be chipped. Due to concerns that the lens could flip inside the patient's eye, hence the lens was not implanted. There was no patient contact with the device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525504 ↗
• MalfunctionAug 27, 2026Scratched Material

  A surgeon reported that, during an intraocular lens (IOL) implantation procedure, no shooter damage was observed, no challenges were encountered during IOL loading or implantation, and the irrigation/aspiration (I/A) handpiece did not contact the optic; however, following implantation, a dent was observed on the optic.Additional information was received that the lens remained implanted in the patient's eye, as only one week had elapsed since implantation and a thorough evaluation had not yet been performed. It was further reported that the patient had not experienced any issues.

  Patient problems: Insufficient Information

  MAUDE report 50470802 ↗
• MalfunctionJan 5, 2026Break

  A PHYSICIAN REPORTED THAT, AFTER THE LENS WAS PREPARED, IT WAS EXAMINED UNDER A MICROSCOPE AND IT WAS FOUND TO BE MISSING ITS HAPTIC TIP. PRODUCT WAS APPLIED ON THE PATIENT. THERE WAS NO PATIENT IMPACT/HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958453 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER FOLDING THE LENS INTO THE COMPANY CARTRIDGE AND LOADING IT INTO THE INJECTOR, CRACKS WERE FOUND ON BOTH SIDES OF THE IOL WHEN IT WAS IMPLANTED INTO THE PATIENT EYE. IT TOOK ABOUT 30 SECONDS FROM SETTING THE IOL TO IMPLANTING IT INTO THE EYE. THERE WAS NO CRACK BEFORE THE IOL WAS SET, IT SEEMS THAT THE CRACK OCCURRED AFTER THE IOL WAS SET. THE SURGEON CUT AND DIVIDE THE IOL IN PIECES INSIDE THE EYE AND REMOVED IT, THEN IMPLANTED AN IOL OF THE SAME TYPE AND POWER INTO THE EYE AGAIN AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23704037 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC DEFECT WAS DETECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE DEFECT OF THE HAPTIC PART OF THE LENS DETECTED DURING SURGERY. THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED AND LENS WAS REPLACED. PATIENT CONDITION NOTED TO BE SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596019 ↗
• MalfunctionMay 15, 2025Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING IMPLANTATION, A SCRATCH WAS FOUND ON THE IOL OPTIC. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE HAD BEEN NO HEALTH HARM, LENS MAY BE EXPLANTED IF ANY OCCURS. THE SAMPLE WAS NOT AVAILABLE AS IT STILL REMAIN IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026483 ↗
• MalfunctionMay 8, 2025Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LOADING NOTICED A MISSING HAPTIC. THE SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21987686 ↗
• MalfunctionMay 2, 2025Scratched Material; Scratched Material

  A NURSE REPORTED WITH A DESCRIPTION OF HAPTIC JUNCTION WAS SCRATCHED, BEFORE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950743 ↗
• MalfunctionJan 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED CRACK ON THE LENS. THE SURGEON HAD CUT THE LENS TO REMOVE IT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264767 ↗
• MalfunctionSep 26, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY A SCRATCH WAS FOUND ON THE OPTICAL SURFACE OF THE INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED. THERE WAS NO VISUAL LOSS AND NO PATIENT HARM. THE LENS REMAINS IMPLANTED IN PATIENT'S EYE. THE INCISION SIZE FOR SURGERY WAS 2.4MM. ACCORDING TO THE REPORTER THE FACILITY HAS FOUND NUMEROUS SCRATCHES ON THE OPTICAL SURFACES (SIX IN TWO DAYS). THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 6 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309272 ↗
• MalfunctionMay 24, 2024Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS LOADED IN THE CARTRIDGE SMOOTHLY WITHOUT ISSUE. THE SURGEON IMPLANTED THE LENS WAS NOTICED TEAR IN THE OPTIC AND THE EDGES HAD WHITISH BRITTLE CRACKING. THE LENS WAS CUT AND REMOVED AND NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND UPDATED VIA MEDWATCH FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391156 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18729622 ↗
• InjuryAug 4, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SCRATCH WAS FOUND ON THE LENS AFTER IMPLANTATION. WHEN IMPLANTING THE IOL WITH THE SAME INJECTOR, THE SCRATCH WAS FOUND AGAIN. THE IOL WAS IMPLANTED WITHOUT PROBLEMS AFTER REPLACING THE INJECTOR WITH ANOTHER ONE. INCISION SIZE: 2.4 MM AND REMOVAL SIZE: 3.5 MM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING SCRATCH WAS FOUND ON THE LENS, SO THE WOUND WAS ENLARGED, THE LENS WAS REMOVED, AND A SECOND LENS WAS INSERTED. THE SECOND LENS HAD A SCRATCH, BUT IT WAS LEFT IN PLACE BECAUSE NO HEALTH HAZARD WAS ANTICIPATED. THERE WAS NO POTENTIAL HEALTH IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING SURGEON REQUESTED TO INVESTIGATE THE IOL.

  Patient problems: Eye Injury

  MAUDE report 15162696 ↗