Clareon CNW0T3 (UDI 00380652409742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652409742), received between Mar 16, 2023 and Mar 30, 2026 — classified as 1 injury, 8 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 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.

• MalfunctionMar 30, 2026Material Discolored

  A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED THERE WAS MEMBRANE-LIKE DEPOSIT ON THE INTRAOCULAR LENS, MAKING THE SURFACE CLOUDY AND DIRTY DURING SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DURING THE EXAMINATION, DOCTOR INFORMED PATIENT THAT THERE WAS A DEPOSIT ON THE IOL. HER DISTANT VISION REMAINED UNCHANGED, AS SHE HAD ALREADY BEEN ABLE TO SEE WELL AT DISTANCE BEFORE THE SURGERY, BUT HER VISION BECAME BRIGHTER AND CLEARER.

  Patient problems: Insufficient Information

  MAUDE report 24716477 ↗
• MalfunctionFeb 20, 2026Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS FOUND TO BE DEFECTIVE AND COULD NOT BE INSERTED INTO THE CARTRIDGE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24400022 ↗
• MalfunctionJan 6, 2026Break

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PHYSICIAN COULD NOT PROVIDE US THE REASON FOR THE HAPTIC RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977774 ↗
• MalfunctionAug 18, 2025Break; Break

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS IMPLANTED IN THE SOCKET AND WAS EXPLANTED DUE TO A DAMAGED HAPTIC DURING INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828361 ↗
• MalfunctionJul 2, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PREPARED WITH A CARTRIDGE AND BEFORE IMPLANTATION INTO THE EYE, DIALYSIS IN THE CAPSULE WAS OBSERVED, AND A CAPSULAR RING WAS INSERTED. THE LENS WAS IMPLANTED INTO THE EYE. ALTHOUGH THE RING WAS NOT EXPECTED TO SUPPORT IT, THE LENS WAS OBSERVED TO BE SCRATCHED, SO IT WAS CUT AND REMOVED FROM THE EYE AND IT WAS ALSO STATED THAT DUE TO THE CAPSULAR DIALYSIS, IT WAS DECIDED TO IMPLANT A MONOFOCAL LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383790 ↗
• MalfunctionMay 26, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH NEAR CENTER OF LENS OPTIC DURING IMPLANTATION. LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22084632 ↗
• MalfunctionMay 9, 2025Scratched Material; Scratched Material

  NON-HEALTHCARE PROFESSIONAL DURING SURGERY REPORTED THAT LENS WAS INSERTED IN PATIENT EYE AND THEY HAVE NOTICED A DOT IN THE MIDDLE OF THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND IT WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992847 ↗
• MalfunctionSep 26, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SOMETHING LIKE A SCRATCH WAS FOUND ON THE OPTICAL SURFACE AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT AND THE LENS REMAINS IN THE PATIENT EYE. THERE WAS NO VISUAL LOSS AND NO PATIENT HARM. THE INCISION SIZE WAS 2.4 MM. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 5 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308360 ↗
• InjuryMar 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A SHINY REFLECTING FOREIGN MATERIAL WHICH SEEMED LIKE A PIECE OF METAL WAS FOUND IN THE LENS OPTIC AFTER IMPLANTATION. THE FOREIGN MATERIAL COULD NOT BE REMOVED EASILY AND THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE PRODUCT STILL REMAINS IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AFTER IOL INSERTION, IOP IS SLIGHTLY ELEVATED AT 23.8 MMHG, BUT CAUSALITY IS UNKNOWN.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16553390 ↗