Clareon CCWTT3 (UDI 00380652457439)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652457439), received between Oct 19, 2022 and Jun 8, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GREATER DIFFICULTY DRIVING AT NIGHT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DECREASED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 25429055 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION AND HALOS AROUND LIGHT AT NIGHT. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON MENTIONED AS UNACCEPTABLE VISUAL RESULTS POST OPERATION.

  Patient problems: Visual Disturbances

  MAUDE report 24906196 ↗
• InjuryApr 15, 2026Adverse 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 AND GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 09 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS BLURRED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24884696 ↗
• InjuryMar 13, 2026Product Quality Problem

  A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE HAD BEEN AN UNSPECIFIED ISSUE WITH THE LENS. THE IOL WAS EXPLANTED DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588083 ↗
• MalfunctionFeb 6, 2026Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A DEFECT WAS OBSERVED ON THE OPTIC EDGE OF THE LENS AT THE TIME OF IMPLANTATION. THE IOL REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 24279153 ↗
• MalfunctionFeb 3, 2026Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS CRACKED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND SWITCHED TO ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24246074 ↗
• InjurySep 4, 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 EXTENSIVE GLARE AND CLINICAL REASON FOR EXPLANT BEING GLARE, POOR QUALITY VISION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22965316 ↗
• InjuryJul 21, 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 HAD BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22553736 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCE AND FOREIGN BODY SENSATION. CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA SECONDARY TO LENS IN RIGHT EYE. THE IOL WAS REPLACED WITH A NON COMPANY LENS 1 MONTH, 3 WEEKS, 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 22505820 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT SATISFIED WITH THE SPECTACLE CORRECTION. THE LENS WAS EXCHANGED WITH COMPANY SAME LENS MODEL BUT DIFFERENT DIOPTER VALUE AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT ALSO EXPERIENCED BURNING , STINGING , GLARE AND FATIGUE. PATIENT¿S DISTANCE VISION WAS POOR. AFTER THE REPLACEMENT LENS THERE WAS NO PATIENT IMPACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dizziness; Eye Irritation; Visual Disturbances; Visual Impairment

  MAUDE report 22481497 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD LIGHT SENSITIVITY, DECREASED NEAR VISION, GLARE AND DIMINISHED VISION. THE LENS WAS EXCHANGED WITH AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS MECHANICAL COMPLICATIONS OF THE IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH NON-COMPANY LENS. IN THE SURGEON¿S OPINION MECHANICAL DEFECT OF IOL CONTRIBUTED TO THE EVENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21582470 ↗
• InjuryFeb 24, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT IOL WAS EXCHANGED FOR NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21446923 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD HALOS AND SHADOWS BLOCKS HER VISION, BLURRY VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20570796 ↗
• MalfunctionOct 29, 2024Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, LENS STUCK IN CARTRIDGE/LENS WOULD NOT ADVANCE. ALSO STATED, THE LENS WAS OPENED AND UNUSED, THE BACK HAPTIC WAS STUCK ON THE PLUNGER AND WHILE ATTEMPTING TO RELEASE IT, IT RIPPED. ADDITIONAL INFORMATION WAS RECEIVED, LENS WAS MOSTLY INSERTED AND BACK HAPTIC WAS STUCK ON PLUNGER. DOCTOR HAD TO REMOVE THE LENS AND USED BACK UP.

  Patient problems: Insufficient Information

  MAUDE report 20558830 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THEIR VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL AND DIOPTER OF THE SAME COMPANY'S LENS AFTER THE INITIAL IMPLANT PROCEDURE. NO VITRECTOMY WAS PERFORMED BUT SUTURE OF INCISION OR WOUND NEEDED. THE CAPSULE BAG REMAINED INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20178392 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POST 8 MONTHS OF SURGERY THE PATIENT EXPERIENCED SHAKING IN VISION AND IT DOES NOT HAPPEN WHEN A LOW LIGHT SITUATIONS. READING IS VERY DIFFICULT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT ALSO HAD NEGATIVE DISPHOTOPSIA IN THE PERIPHERY OF MY LEFT EYE AND SLIGHT STARBURSTS AT NIGHT WHEN DRIVING . THE IMAGE APPEARED TO BE SHAKE OR GO BADLY OUT OF FOCUS, IT LASTS FOR A SPLIT SECOND. IT IS VERY SIGNIFICANT WHEN READING AND UNDER BRIGHT LIGHTS. IF I FOCUS ON AN ITEM AND MOVE THE ITEM WHILE FOLLOWING IT, THE SHAKING DOES NOT OCCUR. IN LOW LIGHT SITUATIONS, IT IS ALMOST NON-EXISTENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19447482 ↗
• InjuryMay 21, 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 DIFFICULTY IN FOCUSING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 11 MONTHS 14 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19357488 ↗
• InjuryMar 14, 2024Adverse 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 BLURRY VISION, HALOS, DULL COLOR VISION AND WAS NOT ABLE TO DRIVE AT NIGHT, DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 11 MONTHS 21 DAYS FOLLOWING THE INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18902096 ↗
• InjuryFeb 7, 2024Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENTS DISTANCE VISUAL ACUITY WAS UNCOMFORTABLE. PATIENT EXPERIENCED HAZY AND HALOS. THE NEAR VISION WAS GOOD. THE IOL WAS PERFECTLY CENTERED AND ALIGNED. THE SURGEON OBSERVED SOME FINE CORTICAL WISPS AND WRINKLING TAKEN TO OPERATIONAL ROOM TO CLEAN. THE FOVEA WAS PERFECT. THE POSTOP SHOWS NO IMPROVEMENT. THE HAPTICS WAS OVER ROTATED AT 175 DEGREES. THE SURGEON ASKED PATIENT TO EXCHANGE FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Vitreous Floaters

  MAUDE report 18657916 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS WRONG POWER. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Blurred Vision

  MAUDE report 16493918 ↗
• MalfunctionOct 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE SMUDGES FOUND TO BE LEFT ON THE LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15631288 ↗