Clareon™ CNWTT3 (UDI 00380652468541)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652468541), received between Jun 19, 2023 and Apr 24, 2026 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Product Quality Problem; Material Twisted/Bent

  A NURSE REPORTED WITH THE DESCRIPTION OF DEFECTIVE LENS AND HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24976597 ↗
• InjuryOct 23, 2025Adverse 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, PATIENT HAD DIFFICULTY IN READING. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS POOR FOCUS AT NEAR.

  Patient problems: Blurred Vision

  MAUDE report 23365591 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FOGGY, BLURRY VISION EVEN WITH CORRECTION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21960262 ↗
• MalfunctionFeb 12, 2025Break; Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT, SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21362598 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER SURGERY, ON DAY ONE POST-OPERATION, THE PATIENT HAD MILD CORNEAL EDEMA, PAINFUL YESTERDAY, AND IRRITATION MUCH BETTER TODAY, JUST A LITTLE IRRITATED AND BLURRY VISION. THE PATIENT USED TOPICAL CORTICOSTEROID, ANTIBIOTIC, AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) AND STOPPED THE OCULAR HYPEROSMOTIC AGENT. IN THE FOLLOW-UP VISIT, THE PATIENT WAS 2 ½ WEEKS POST-OPERATION, VISION WAS STILL BLURRY, RIGHT EYE (OD) NOT GOOD EITHER, BUT THERE WAS NO PAIN, NO PRESSURE, USING MED DROPS WELL. THE LENS HAD ROTATED 120 DEGREES AND NEEDED REPOSITIONING OF THE LENS AND DIAGNOSED WITH MILD POSTERIOR CAPSULE OPACIFICATION (PCO). AFTER 4 ½ WEEKS VISIT, QUALITY WAS UNCHANGING. BUT THE LEFT EYE IS PROGRESSING AS GOOD AS OD, SEEN FLASHES OF LIGHT IN THE PERIPHERY OFF/ON LIGHTS ARE STILL BOTHERSOME ALL DAY OU (BOTH EYES), DENIES PAIN/DISCOMFORT BY TAKING CORTICOSTEROID. THE PATIENT ALREADY HAD DRY EYE SYNDROME OF BILATERAL LACRIMAL GLANDS SECONDARY TO TEAR DEFICIENCIES, SO THE PATIENT¿S EYES ARE DRY AND IRRITATED, SO THEY CONTINUED TEARS AND STEROIDS AS PRESCRIBED. AFTER 6 ½ WEEKS VISIT, THE PATIENT WAS VERY LIGHT-SENSITIVE, SO HAS TO WEAR SUNGLASS

  Patient problems: Blurred Vision; Corneal Edema; Dry Eye(s); Excessive Tear Production; Eye Irritation; Eye Pain; Posterior Capsule Opacification; Visual Disturbances; Visual Impairment

  MAUDE report 21354659 ↗
• InjuryJan 9, 2025Adverse 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 EXPERIENCED WITH DESIRED BETTER UNCORRECTED VISION AND MYOPIC ASTIGMATIC CORRECTION WITH FLIPPED ASTIGMATISM. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 23 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MYOPIC ASTIGMATIC CORRECTION WITH FLIPPED ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21111323 ↗
• InjuryDec 4, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; 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 BLURRY VISION. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION WITH INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842896 ↗
• InjurySep 26, 2024Adverse 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 ONE AND HALF A DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20310301 ↗
• InjuryJul 23, 2024Adverse 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 EXPERIENCED VISUAL PRISON, SHUTTERED UNSTABLE VISION. CLINICAL REASON FOR EXPLANT WAS SUBJECTIVE VISUAL DISSATISFACTION. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 2/2 OF BILATERAL FILE.

  Patient problems: Visual Impairment

  MAUDE report 19804751 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT THE PATIENT HAD ENDOPHTHALMITIS AND BEST CORRECTED VISUAL ACUITY DECREASED IN THE RIGHT EYE OF A 71 YEAR OLD MALE PATIENT AFTER CATARACT SURGERY. THE PATIENT CURRENT CONDITION WAS IMPROVING. IT WAS UNDETERMINED WHICH PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, THEREFORE ALL MANUFACTURER PRODUCTS USED DURING THE INITIAL PROCEDURE HAVE BEEN CAPTURED.

  Patient problems: Endophthalmitis; Visual Impairment

  MAUDE report 18194971 ↗
• InjuryAug 22, 2023Malposition of Device; Malposition of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED COLOR VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS OF SAME MODEL WITH DIFFERENT DIOPTER. THE CLINICAL REASON FOR EXPLANT WAS DISLOCATED LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, IN THE SURGEON'S OPINION, THE DISLOCATED LENS CAUSED THE EVENT. THERE WAS NO PATIENT HARM. IN THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 17595763 ↗
• MalfunctionJun 19, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED. THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17150812 ↗