Clareon CNW0T3 (UDI 00380652409773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652409773), received between Mar 17, 2025 and Oct 20, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL BUT FOUR A DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 23334844 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT BEGAN EXPERIENCING HALOS AND GLARE, RESULTING IN AN INABILITY TO DRIVE AT NIGHT. THE PATIENT WAS ADVISED TO CONTINUE USING PRESERVATIVE-FREE ARTIFICIAL TEARS (LUBRICATING EYE DROPS) 3¿4 TIMES DAILY. ADDITIONALLY, A TAPERING REGIMEN OF A CORTICOSTEROID WAS INITIATED, WITH INSTRUCTIONS TO INSTILL ONE DROP IN THE RIGHT EYE (OD) ONCE DAILY FOR ONE WEEK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22095827 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 7 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926305 ↗
• MalfunctionMar 17, 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 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621854 ↗