Clareon CCWTT0 (UDI 00380652413718)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00380652413718), received between Sep 14, 2022 and Feb 9, 2026 — classified as 25 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED HAPTIC WAS BENT. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE FRONT HAPTIC COME OUT FASTER AND WAS BENT.

  Patient problems: Insufficient Information

  MAUDE report 24293953 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT CONTINUED TO HAVE ISSUES WITH HER INTERMEDIATE VISION.

  Patient problems: Blurred Vision

  MAUDE report 24004360 ↗
• InjurySep 4, 2025Adverse 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 BLURRED VISION AND SEES LENS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22962287 ↗
• InjurySep 4, 2025Adverse 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 BLURRED VISION AND SEES LENS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 22961585 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON- HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22782791 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXCHANGED WITH COMPANY SAME LENS MODEL BUT DIFFERENT DIOPTER AND TORIC VALUE. REASON FOR EXPLANT WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22660256 ↗
• InjuryJul 25, 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) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS AFFECTING HIS DAILY LIFE, AND HIS VISION WAS UNACCEPTABLE AND UNCOMFORTABLE TO DRIVE AT NIGHT. THE IOL WAS REPLACED WITH A COMPANY MONOFOCAL IOL 10 MONTHS, 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POSITIVE DYSPHOTOPSIA. THE SURGEON¿S PROGNOSIS INDICATED A GOOD POSTOPERATIVE APPEARANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22608601 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED UNCLEAR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 19 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POOR VISION EVEN AFTER ACCOUNTING FOR POST-OPERATIVE REFRACTIVE ERROR AND HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21321581 ↗
• MalfunctionJan 3, 2025Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATING IOL CRACKED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21067083 ↗
• MalfunctionSep 27, 2024Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED WITH DESCRIPTION LENS WOULD NOT LOAD CORRECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20320849 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT HAD MALADAPTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20135779 ↗
• InjurySep 4, 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 HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTHS AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20134437 ↗
• InjuryJul 15, 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 SEVERE PERIPHERAL SHADOWS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 19 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS SEVERE NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT EXPERIENCED SEVERE SHADOWS IN LEFT SIDE OF VISION. ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS EXCHANGED FOR A NON-COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 19741482 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA, POOR QUALITY OF VISION AND MILD HYPEROPIA. THE LENS WAS REPLACED WITH THE COMPANY LENS. NO PATIENT HARM.

  Patient problems: Dry Eye(s); Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19711178 ↗
• InjuryJun 11, 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 AND CLINICAL REASON FOR EXPLANT BEING PATIENT DIDN'T ADAPT TO LENS . THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: Blurred Vision

  MAUDE report 19508734 ↗
• InjuryMay 14, 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, THE PATIENT UNHAPPY WITH VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT UNABLE TO TOLERATE HALOS AND NEUROADAPTIVE INTOLERANCE OF MULTIFOCAL IOL.

  Patient problems: Halo; Visual Impairment

  MAUDE report 19308815 ↗
• InjuryMar 18, 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, PATIENT EXPERIENCED HALOS AND GLARE WHEN DRIVING. LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.THE CLINICAL REASON WAS REPORTED TO BE PATIENT UNHAPPY WITH VISION. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY THREE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THE SYMPTOMS RESOLVED AFTER LENS REPLACEMENT.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18920486 ↗
• InjuryFeb 20, 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 IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18744860 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED GLARE, BRIGHTNESS AND HALOS AT NIGHT. HE STATES HIS VISION WAS GOOD BUT THE GLARE, BRIGHTNESS AND HALOS WERE A PROBLEM. PATIENT SPOKE TO HIS SURGEON AND SURGEON STATED IT WAS DUE TO DRY EYE AND PLACED HIM ON CALCINEURIN INHIBITOR DROPS, BUT DOES NOT FEEL THAT IS THE ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Dry Eye(s); Halo; Visual Disturbances; Visual Impairment

  MAUDE report 18692401 ↗
• MalfunctionDec 6, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MARK ON LENS WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18273036 ↗
• InjuryDec 6, 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 EXPERIENCED GLARE AND BLURRY VISION. HE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL REFRACTIVE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 13 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 7 OF 13 FILES.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18272948 ↗
• MalfunctionNov 15, 2023Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, DOCTOR STATED THAT THE LENS GOT STUCK IN THE CARTRIDGE IN THE DISTAL END HALF WAY INTO THE EYE. AS PER SOURCE DOCUMENT THERE WAS THEY ARE NOT SURE IF THERE WAS PATIENT CONTACT, PROCEDURE IS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18137873 ↗
• MalfunctionSep 27, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE AND AFTER IMPLANTATION, IN THE OPERATING ROOM, THE PHYSICIAN NOTICED A HUGE SCRATCH IN THE CENTER OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17822946 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COMPLAINED OF HAVING LIMITED DISTANCE VISION, INABILITY TO PERFORM JOB WITH EXTENDED COMPUTER USE AND DIFFICULTIES WITH NIGHT DRIVING. HOWEVER, ACCORDING TO PHYSICIAN DESPITE THE FACT THAT ALL THESE RISKS/ISSUES WERE DISCUSSED WITH THE PATIENT PRE-OPERATIVELY, THE PATIENT PERSISTS IN COMPLAINING ON ALL THESE ISSUES AFTER SURGERY. IN PHYSICIAN'S OPINION THE CATARACT SURGERY WAS SUCCESSFUL AND IN BOTH EYES DESIRED OUTCOME WAS ACHIEVED. THE PATIENT WAS ABLE TO SEE BETTER WITH SMALL PRESCRIPTION GLASSES USED AFTER CATARACT SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17380247 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL) IN THE RIGHT EYE, THE PATIENT COULD SEE THE TINY PRINT BUT ANYTHING PAST 20 FEET IS OUT OF FOCUS. THE PATIENT WAS EXPERIENCING BLURRY VISION TO THE RIGHT SIDE OF THE ROAD. THEREFORE, THE PATIENT WAS FACING DIFFICULTIES WHILE DRIVING. THE PATIENTS RIGHT EYE, GIVES CLEAR VISION FOR CLOSE BUT NOT FOR MID AND FAR VISION. THE PATIENT FEELS THAT SOMETHING WAS WRONG WITH THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RIGHT EYE OF THE PATIENT COULD SEE CLOSE UP BUT NO MEDIUM OR FAR DISTANCE. THE PATIENT ALSO HAS DISCUSSED THE ISSUE WITH THE EYE CARE PROVIDER.

  Patient problems: Blurred Vision

  MAUDE report 17059726 ↗