Clareon CNWET3 (UDI 00380652466448)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652466448), received between Sep 5, 2023 and Mar 30, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS IOL ROTATION AND REFRACTIVE MISS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24715162 ↗
• MalfunctionJan 5, 2026Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR NOTICED A HAIRLINE SCRATCH ON THE OPTIC WHILE IMPLANTING IN THE PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED AND THE BACKUP LENS WAS USED DURING INITIAL PROCEDURE. NO OTHER PROBLEMS OCCURRED, NO HARM TO THE PATIENT, AND ALL WENT WELL. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970852 ↗
• MalfunctionAug 21, 2025Break; Inaccurate Delivery; Break; Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS FAULTY (NOT HAPTIC) / LENS COULD NOT BE USED. ADDITIONAL INFORMATION WAS RECEIVED STATING SCRUB NURSE LOADED THE LENS INTO CARTRIDGE AND INJECTOR AS USUAL. WHEN SURGEON INSERTING LENS INTO THE EYE REALISED THAT THE LENS WAS LOADED UPSIDE DOWN SO HE ABORTED AND UPON PULLING OUT LENS TRAILING HAPTIC BROKE OFF. SURGEON WAS THEN ABLE TO SUCCESSFULLY REMOVE THE REST OF THE LENS OUT OF THE MAIN WOUND. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS WITH NO ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 22861045 ↗
• InjuryMay 30, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NEEDED SURGERY TO ROTATE THE IOL. DURING THE ATTEMPT TO ROTATE, THEY WERE UNABLE TO DO SO BECAUSE THE HAPTIC COULD NOT ROTATE. THE IOL WAS EXCHANGED FOR THE SAME MODEL AND SAME DIOPTER TORIC LENS FROM THE SAME COMPANY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22112128 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PERFECT VISION ONLY AT CLOSE RANGE, CANNOT ABLE TO IDENTIFY PEOPLE OR OBJECTS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21036576 ↗
• MalfunctionJul 16, 2024Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE LENS.ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS LOADED IN TO THE PATIENT AND SCRATCH WAS NOTICED. THE LENS WAS REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750022 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD UNEXPECTED HYPEROPIC RESULT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 10 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18407893 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. HENCE THE LENS WERE EXPLANTED AND REPLACED WITH TORIC LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS IMPLANT FAILURE, MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17681267 ↗