Clareon CNWTT0 (UDI 00380652408219)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652408219), received between Jul 14, 2022 and Mar 30, 2026 — classified as 4 injuries, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DIFFICULT TO ADVANCE THROUGH THE CARTRIDGE, ACCOMPANIED BY A SHOT SOUND. THE IOL WAS DEFORMED AND HAPTIC TORN. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT, THE DEFECT OCCURRED DURING THE SURGERY. THE SURGERY WAS COMPLETED WITH THE SAME IOL. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE AND AFTER THE SURGERY, THE VISION OF THE OPERATED EYE WAS 0.8. THE PATIENT WAS DISCHARGED WITH IMPROVEMENT. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729819 ↗
• MalfunctionMar 4, 2026Break; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DIFFICULT TO ADVANCE THROUGH THE CARTRIDGE, ACCOMPANIED BY A SHOT SOUND. THE IOL WAS DEFORMED AND HAPTIC TORN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510207 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE EXPERIENCED WITH HALOS SO BIG IN THE NIGHTTIME AND LOOKING AT ANY BRIGHT LIGHTS LIKE CAR LIGHTS, SIGNAL LIGHTS, BIKE LIGHTS, TORCH LIGHTS, DECORATION LIGHTS, STREETLIGHTS AND CANNOT EVEN SEE THE SOURCE OF THE LIGHTS. WHICH MADE HER DIFFICULT TO GET OUT OF THE HOUSE IN THE NIGHTTIME AND MAKING DRIVING IMPOSSIBLE AS THE HALLOW LIGHTS FROM THE CARS OPPOSITE SIDE REFLECTION MAKING IMPOSSIBLE TO SEE SIDE OF THE LANE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo

  MAUDE report 24052449 ↗
• MalfunctionDec 19, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN NOTICED A SCRATCH ON THE IMPLANT. THE SCRATCH WAS OBSERVED DURING DEPLOYMENT INTO THE CAPSULAR BAG. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850672 ↗
• MalfunctionSep 5, 2025Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED A DAMAGED LENS ON LOADING, NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22978795 ↗
• MalfunctionMay 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS DAMAGED DURING IMPLANTATION. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22024289 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS, STARBUSTS DURING DAY. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21123315 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 08 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20755424 ↗
• MalfunctionJan 9, 2023Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED A SCRATCH WAS FOUND ON THE INTRAOCULAR LENS OPTIC SO THE IOL WAS REMOVED FROM THE PATIENT'S EYE.

  Patient problems: Insufficient Information

  MAUDE report 16122743 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION AND DIZZINESS. THE EXCHANGE WAS PROCEEDED AS A SECONDARY PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 15010920 ↗