Clareon™ CNWTT3 (UDI 00380652468527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652468527), received between Dec 28, 2022 and Aug 28, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50497674 ↗
• MalfunctionApr 21, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS WAS BROKEN AND THE OPERATION HAD TO BE STOPPED AND RESCHEDULED. THERE WAS NO PATIENT CONTACT. 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 24937534 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE INTRA OCULAR LENS (IOL) WAS EXCHANGED FOR THE SAME LENS MODEL AND POWER BUT NON-TORIC INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 22662881 ↗
• MalfunctionMar 14, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE INTRAOCULAR LENS HAD A HUGE CRACK OR SCRATCH ACROSS THE CENTER. THE TECH DID HAVE ISSUES WITH 3 OTHER LENSES THAT DAY BUT IT WAS HER CONFIDENCE IN LOADING THE LENSES THAT CAUSED THE ISSUES. THE LENS WAS EXTRACTED FROM THE EYE AND A NEW LENS WAS INSERTED WITH NO FURTHER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 21603876 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, PATIENT EXPERIENCED HALOS AROUND LIGHTS AT NIGHT, THREE RINGS,ALSO IT WAS HARD FOR PATIENT TO SEE WHILE DRIVING DURING NIGHTS. PATIENT'S PHYSICIAN STATED THAT IT WOULD GO AWAY OVER TIME BUT IT WAS NOT IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

  Patient problems: Halo

  MAUDE report 19022922 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEAD NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS INCORRECT LENS POWER - PATIENT COMPLAINED OF BLURRY VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17255722 ↗
• InjuryDec 28, 2022Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FALL TO BACK OF THE EYE DURING SURGERY. AS THE LENS WAS BEING ROTATED WITH SINSKEY HOOK TO THE AXIS OF THE ASTIGMATISM THE LENS APPEARED TO THE HEAD POSTERIORLY. THERE WAS NO OBVIOUS VITREOUS LOSS BUT THE IOL APPEARED TO BE SUBLUXED INTO THE VITREOUS CAVITY. A 10 NYLON SUTURE WAS PLACED IN THE TEMPORAL INCISION AND BALANCED SALT SOLUTION ON CANNULA WAS THEN USED TO STROMAL HYDRATION OF THE PARACENTESIS. THE INCISION WERE CHECKED AND NOTED TO BE WATERTIGHT SEVERAL DROPS OF 5% BETADINE WERE PLACED IN THE OPERATIVE EYE WHICH AS THEN PATCHED AND SHIELDED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS REFERRED TO RETINAL SPECIALIST FOR REMOVAL OF SUBLUXED IOL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16060770 ↗