Clareon CNW0T3 (UDI 00380652409681)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652409681), received between Nov 20, 2024 and Sep 25, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Scratched Material

  A physician reported that during an intraocular lens (IOL) implantation procedure, surgeon observed that the support tip was chipped after IOL insertion as usual. The procedure was completed on the same day without any harm to the patient. 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 50894915 ↗
• MalfunctionAug 10, 2026Break

  A healthcare professional stated, with the description, that the lens duck broke. It was considered to be because of the cartridge. The patient was left unoperated.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50193910 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION, SHADOWING, DOUBLE VISION. CLINICAL REASON BEING MENTIONED AS PATIENT DISSATISFACTION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 25468706 ↗
• MalfunctionMar 31, 2026Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS HAD BROKEN WHILE BEING INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24743401 ↗
• MalfunctionMar 18, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TORN OR BROKEN HAPTIC HAD BEEN OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628895 ↗
• MalfunctionMar 28, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, LENS WAS IMPLANTED AND EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, ACCORDING TO SURGEON THE 3 DOTS FOR TORIC WAS NOT ALIGNED WITH HAPTIC. IN THE SURGEON OPINION, COMPANY DEFECTIVE LENS CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM. SURGEON IMPLANTED ANOTHER UNSPECIFIED LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721549 ↗
• MalfunctionMar 18, 2025Material Opacification; Material Opacification

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A WIPEABLE FILM ON THE IOL WHICH COULD BE REMOVED SOMEWHAT AFTER IMPLANTATION WITH THE BIMANUAL IRRIGATION/ASPIRATION (I/A) HANDPIECES. THERE WAS A PATIENT CONTACT AND IOL HAD REMAINED IN THE PATIENT EYES. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED AS PER SURGEON WIPEABLE FILM ON THE INTRAOCULAR LENS (IOL) WAS A FINE, IRREGULAR, STRUCTURED AND THIN DEPOSIT WHICH CAN BE DRAW A TRACK WITH AN INSTRUMENT (EXAMPLE REPORTED AS A RINSING HANDLE), SO ABRASION WOULD BE POSSIBLE. WIPEABLE FILM ON THE IOL WAS VISIBLE BEFORE CONTACT WITH VISCOELASTIC. IN SURGEON OWN CASE LENS EPITHELIUM MIGRATION ALSO TOOK PLACE QUITE QUICKLY ON THIS LAYER. SURGEON HAD ONLY SEEN ONE CASE AND MOSTLY OTHER PATIENTS ARE REFERRED. SURGEON WOULD NOT SEE THEM AGAIN. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632386 ↗
• MalfunctionDec 10, 2024Material Discolored; Material Discolored

  ADDITIONAL INFORMATION WAS RECEIVED, INTRAOCULAR LENS FINDING WAS ALMOST DISAPPEARED ABOUT 1 MONTH AFTER THE INITIAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890518 ↗
• MalfunctionNov 20, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) SCRATCHED AND THE IMPLANT PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735987 ↗