Clareon CNW0T3 (UDI 00380652409735)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652409735), received between Jan 4, 2022 and Oct 29, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC LENS ARM WAS FOLDED AND DID NOT RELEASE UPON APPLICATION OF COMPANY VISCOELASTIC TO THE CARTRIDGE. THE ISSUE WAS NOTED DURING LOADING OF THE LENS INTO THE CARTRIDGE AND THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED ON THE SAME DAY. IN THE SURGEON¿S OPINION, THE HAPTIC ARM WAS FAULTY, THUS NOT SETTING CORRECTLY IN THE CARTRIDGE, CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412284 ↗
• InjuryAug 20, 2024Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING IT WAS NOTICED THE BOTH HAPTICS TORN OFF SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS AND ENDOTHELIAL DAMAGE WAS ALSO NOTICED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20000823 ↗
• MalfunctionJul 2, 2024Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORIC LENS WAS IMPLANTED BUT REMOVED. THE EMBOSSED DOTS ON THE LENS FOR THE ALIGNMENT PURPOSES WERE NOT CORRECT ON THE LENS OR NOT IN THE CORRECT LOCATION AND SEEMS A MANUFACTURING ISSUE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19655876 ↗
• MalfunctionJan 4, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A LARGE SCRATCH WAS CONFIRMED ON THE OPTICAL PART, AFTER INSERTING THE LENS. THE SURGERY WAS COMPLETED BY RETAINING THE LENS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096750 ↗
• MalfunctionJan 4, 2022Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A FOREIGN MATERIAL WAS FOUND ON THE BACK OF OPTIC IMMEDIATELY AFTER IMPLANTATION. A PART OF IT WAS REMOVED BY IRRIGATION/ASPIRATION(IA), BUT IT COULD NOT BE COMPLETELY REMOVED. THE SURGERY WAS COMPLETED WITH THE SAME LENS. ON THE SECOND DAY AFTER THE SURGERY PHYSICIAN CHECKED A PHOTO, A CIRCULAR SCRATCH SIMILAR TO A TORIC MARK WAS FOUND NEAR THE FOREIGN MATERIAL AND IT WAS FOUND THAT A FOREIGN MATERIAL THAT SEEMED TO BE SCRAPED FROM THE SCRATCHED PART REMAINED. THERE WAS NO EFFECT ON THE PATIENT'S VISUAL ACUITY AND THERE WAS NO POSTOPERATIVE INFLAMMATION AT THE MOMENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING 1MM WHITE TRANSPARENT FIBROUS FOREIGN MATERIAL ON THE BACK OF THE IOL, SLIGHTLY BELOW THE CENTER. DURING SURGERY, IMMEDIATELY AFTER IOL INSERTION, TWO PALE FOREIGN MATERIALS WERE STUCK TO THE BACK OF THE LENS ALONG WITH A 1MM-SIZED SCRATCH WE TRIED TO ASPIRATE IT OUT WITH IA, AND PART OF IT WAS REMOVED, BUT IT COULD NOT BE COMPLETELY REMOVED. CONSIDERING THE POSSIBILITY OF LENS CORTEX RESIDUE, THE SURGERY WAS COMPLETED WITHOUT ANY ADDITIONAL TREATMENT. AS OF THE 11TH DAY AFTER THE SURGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151606 ↗