Clareon CCWTT3 (UDI 00380652457415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652457415), received between Feb 3, 2023 and Nov 14, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 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 NEVER HAD GOOD VISION SINCE THE SURGERY. SHE STATED THEY WERE UNABLE TO CORRECT HER VISION AND POSSIBLY HAD MACULAR DEGENERATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR RIGHT EYE.

  Patient problems: Retinal Degeneration; Visual Impairment

  MAUDE report 23555650 ↗
• InjurySep 12, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED HALOS, GLARE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE DYSPHOTOPSIA. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN SIX MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT SYMPTOMS WERE RESOLVED. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Visual Disturbances

  MAUDE report 23039333 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT COULD NOT SEE VERY WELL. THE LENS WAS EXCHANGED WITH COMPANY SAME MODEL AND DIFFERENT DIOPTER LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS BREAKDOWN OF IOL.

  Patient problems: Blurred Vision

  MAUDE report 22715240 ↗
• InjuryJul 22, 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 HALOS, IMPACTING DAILY LIFE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT A NONCOMPANY LENS WAS USED. 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 22565680 ↗
• InjuryJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT AND CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE DISPLACED LENS.THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY THREE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22150439 ↗
• InjuryMar 5, 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. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21525922 ↗
• InjuryNov 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 HAD POOR QUALITY AND WAXY IN NATURE. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 7 MONTHS AND 16 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PATIENT TESTS WELL AT DISTANCE AND NEAR ON VISION CHART BUT DESCRIBES THE VISION AS POOR QUALITY AND WAXY IN NATURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20692576 ↗
• InjuryNov 14, 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 WAS UNHAPPY VISION WITH LENS. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION WITH IOL (INTRAOCULAR LENS). 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

  MAUDE report 20688295 ↗
• MalfunctionNov 5, 2024Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED A SCRATCH ON THE LENS AFTER IMPLANTATION THROUGH THE MICROSCOPE, THEN IMMEDIATELY EXCISED THE DAMAGED LENS WAS REMOVED AND REPLACED. SURGERY COMPLETED WITHOUT COMPLICATION. THE PATIENT IS DOING WELL AND IS EXPECTED TO MAKE A 100 PERCENT RECOVERY. THERE IS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608405 ↗
• InjuryOct 28, 2024Material Discolored; Material Discolored

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED CORNEAL EDEMA POST OPERATION THAT HAS INCREASED OVER TIME. PUPIL HAS BECOME FIXED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LENS APPEARS COVERED WITH A THIN IRREGULAR FILM OF TAN, WHITE MATERIAL MOST CONSISTENT WITH EITHER FIBRIN OR BSS (B-SCAN ULTRASOUND), ALSO CRYSTALLINE TYPE DEPOSITS ON ONE SIDE OF THE OPTIC POTION OF THE LENS. PATHOLOGIST SAID THAT FINDINGS COULD BE CONSISTENT WITH A TOXIC SUBSTANCE ON THE LENS, BUT SHE DIDNT HAVE ANY WAY OF TESTING FOR THIS. FINDINGS ARE NONSPECIFIC, SURGEON SAW A PUZZLING POST OPERATIVE OUTCOME CLOSEST TO TASS (TOXIC ANTERIOR SEGMENT SYNDROME) BUT VERY ISOLATED IN NATURE, BUT THEY WERE ALL IMPLANTED COMPANY LENS. PATHOLOGY REPORT, STATES THAT PATIENT HAD POSITIVE OUTCOME AND THERE WAS NO RETINAL DAMAGE. THE PUPILS DID NOT RECOVER OR DILATED POST PROCEDURES, ALSO HAD AC (ANTERIOR CHAMBER) WASHOUT, IOP (INTRAOCULAR PRESSURE) EXCHANGE AND LENS SENT FOR EVALUATION. CORNEAL NEVER RECOVERED. AND THIS IS ABOUT 3 MONTHS AFTER THE AC WASHOUT BUT BEFORE THE DMEK (DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY) AND PUPIL LOOKS A LI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Inflammation

  MAUDE report 20543874 ↗
• InjuryOct 9, 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 HALOS AND STARBURST SO BAD UNABLE TO NIGHT DRIVE AND DIFFICULTY WITH DAYLIGHT DRIVING IN SUN. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTH AND 25 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20405364 ↗
• InjurySep 5, 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 AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20145658 ↗
• InjuryApr 3, 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. LENS WAS EXCHANGED FOR ANOTHER COMPANY LENS MODEL 10 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19032255 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED CORNEAL EDEMA POST OPERATION THAT HAS INCREASED OVER TIME. PUPIL HAS BECOME FIXED. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 18875482 ↗
• InjuryFeb 16, 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 GLARE AND HALOS AT NIGHT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18721384 ↗
• InjuryOct 16, 2023Adverse 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 WAS UNHAPPY WITH HER NEAR VISION. SURGEON WAS UNSURE WHY THE PATIENT WAS COMPLAINING AS HER MEDICAL RECORDS WOULD INDICATE GOOD VISUAL ACUITY. HE HAS COUNSELED HER THAT SHE NEEDS BOTH EYES TO WORK TOGETHER BEFORE EVALUATING HER VISION. SURGEON HAS PERFORMED YTTRIUM ALUMINUM GARNET (YAG), SO THERE WILL NOT BE A LENS EXCHANGE.

  Patient problems: Blurred Vision

  MAUDE report 17938692 ↗
• InjuryMay 10, 2023Adverse 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 EXPERIENCED BLURRED VISION (NEAR AND FAR). THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER FIVE MONTH OF INITIAL IMPLANTATION. THE REPLACED LENS WAS NON COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 16901320 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED INTOLERABLE HALOS AT NIGHT, AND WAS UNABLE TO DRIVE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POSITIVE DYSPHOTOPSIA. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION RECEIVED STATING THE ISSUE WAS NOTICED ONE WEEK POST OPERATIVELY AND THE SYMPTOMS HAVE RESOLVED AFTER THE LENS EXCHANGE. THE PROGNOSIS WAS GOOD.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16745402 ↗
• MalfunctionMar 31, 2023Component Missing; Component Missing

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT WHILE POSITIONING THE INTRAOCULAR LENS (IOL) DURING IMPLANTATION PROCEDURE, IT APPEARED THAT A SECTION OF THE IOL WAS MISSING. THEREFORE, THE LENS WAS CUT INTO TWO PIECES AND REMOVED. THE SURGERY WAS COMPLETED USING BACKUP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED STATED THAT THE IOL WAS CUT INTO TWO PIECES AND REMOVED FROM PATIENT'S RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654563 ↗
• InjuryFeb 3, 2023Crack; Crack

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE . THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER ONE MONTH OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS CRACK IN OPTIC. ADDITIONAL INFORMATION RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 16293557 ↗