Clareon CCWTT3 (UDI 00380652457378)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380652457378), received between Apr 24, 2023 and Sep 15, 2026 — classified as 21 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A non-healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced poor vision. Hence the lens was explanted and replaced with another non-company IOL in a secondary procedure. The clinical reason for explant was other mechanical complications of lens.Additional information was requested and received, stating that the patient also experienced light flutter; however, there was no further impact on the patient.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50769598 ↗
• InjuryAug 7, 2026Device Dislodged or Dislocated

  A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, the patient had experienced blurred vision, halos and unhappy with vision. The lens was rotated and repositioned by the surgeon approximately three months after the surgery.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 50174271 ↗
• InjuryFeb 21, 2026No Apparent Adverse Event

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS. THE LENS WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24408634 ↗
• InjuryDec 17, 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 VISION QUALITY WAS NOT GOOD AND THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23826899 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON NEW INFORMATION RECEIVED, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE - THERE WAS HYPEROPIC MISS BY +1.00, FOLLOWING IMPLANTATION OF THE ORIGINAL INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THE IOL EXCHANGE WAS DONE WITH A SAME COMPANY LENS MODEL BUT ONE AND HALF DIOPTER MORE POWER. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ACCORDING TO THE SURGEON, WITH THE NEW LENS THE GOAL OF TARGET REFRACTION OF PLANO SPHERE WILL BE OBTAINED. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 23692024 ↗
• InjuryJul 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, THE PATIENT EXPERIENCED BLURRY VISION AND UNABLE TO DO DAILY ACTIVITIES AS HE DESIRES. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS MODEL 1 YEAR 7 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS BLURRED VISION. THE PATIENT UNDERWENT YAG LASER PROCEDURE AND PATIENT DISTANCE VISION WAS IMPROVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22577046 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE IOL WAS NOT MIS-LABELED. ONE MONTH AFTER THE CATARACT SURGERY WITH COMPANY LENS, PATIENT CAME IN COMPLAINING OF A GREY FILM OVER VISION AND THAT DISTANCE VISION WAS NOT AS CLEAR AS IT WAS RIGHT AFTER SURGERY. IN THE SURGEON¿S OPINION INCORRECT IOL POWER CONTRIBUTED TO THE EVENT. THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22175730 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL BUT ONE AND HALF DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22115776 ↗
• InjuryFeb 24, 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 HAD FOGGY AND GLARE ISSUES. THE IOL WAS EXCHANGED FOR NON COMPANY LENS MODEL 8 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS IOL CALCULATIONS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21445227 ↗
• InjuryJan 30, 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 HAD GLARE/POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS AND 14 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS GLARE AND POOR BLURRY VISION. ADDITIONAL INFORMATION HAS RECEIVED STATING THAT THE PATIENT HAD COMPLAINTS OF POOR VISION, BLURRY VISION AND GLARE WHICH WERE WORSENING SINCE INITIAL SURGERY. THE SURGEON DID NOT BELIEVE ANYTHING WAS WRONG WITH THE LENS OR DIOPTER, JUST THAT THE PATIENT WAS VERY UNHAPPY WITH VISION OUTCOME, ESPECIALLY THE AMOUNT OF GLARE. THERE WAS NO PATIENT HARM POST EXPLANT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21273184 ↗
• InjuryDec 3, 2024Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POOR VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS LENS MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20829325 ↗
• InjuryNov 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 PATIENT EXPERIENCED VISION IS BLURRY. THE IOL WAS EXCHANGED FOR THE ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS NO IMPROVEMENT IN PATIENT VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20735570 ↗
• 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 STATED THAT HIS VISION WAS WORSENED. CLINICAL REASON BEING MENTIONED AS DISCOMFORT WITH DISTANCE AND READING VISION AND THEY HAVE PLANNED EXPLANT WITH UNKNOWN MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20133396 ↗
• MalfunctionJun 28, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH SEEN ON LENS IMMEDIATELY AFTER IMPLANTATION.LENS WAS EXPLANTED DURING INITIAL PROCEDURE.THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632274 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL AND THERE WAS NO PATIENT HARM, PATIENT ISSUES RESOLVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19048867 ↗
• MalfunctionApr 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY, THE PATIENT UCVA WAS 20/40. THE LENS WAS NOT ON AXIS OF ASTIGMATISM. THE PATIENT WAS SCHEDULED FOR SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IOL EXCHANGE WAS NOT PERFORMED AND LENS REMAINS IN PATIENTS EYE. THEY WERE CONSIDERING A LASIK FOR RESIDUAL REFRACTIVE ERROR.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19042664 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, RIGHT VISION AFTER SURGERY WAS IN 20/50-20/60 RANGE WITH REFRACTION OF PLANO -1.25 X 115 (REPEATED 4 TIMES AT 4 SEPARATE VISITS OVER THE SPAN OF 2 MONTHS). THE PATIENT HAD ISSUES WITH DRY EYE SYNDROME AND THIS WAS TREATED MORE AGGRESSIVELY AFTER SURGERY THAN BEFORE (ALSO THE REASON FOR THE NUMBER OF POST OP VISITS). THE SURGEON LOOKED AT TRYING TO FIX THE ASTIGMATISM THAT REMAINED BUT ASTIGMATISMFIX.COM SHOWED THAT THE IOL POWER WAS NOT STRONG ENOUGH FOR A ROTATION OF THE AXIS TO WORK. REPEAT MEASUREMENTS WERE THEN DONE AND SHOWED THAT A COMPANY LENS 18.5D AT 012 DEGREES SHOULD BE THE LENS OF CHOICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Dry Eye(s); Visual Impairment

  MAUDE report 18892142 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION, WAXY VISUAL ACUITY AND THE PATIENT WAS EXTREMELY UNHAPPY. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS ANISOMETROPIA, VISUAL DISTURBANCE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18474626 ↗
• MalfunctionDec 22, 2023Material Opacification; Scratched Material; Material Opacification; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS SMUDGE ON THE LENS. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL . ADDITIONAL INFORMATION WAS RECEIVED AND NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18381549 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 18180542 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS HAVING SUCH BAD RINGS AND GLARE IN HER VISION AT NIGHT. THE PATIENT WAS NOT ABLE TO DRIVE. THE PATIENT WAS HAVING THESE ISSUES FOR OVER AN YEAR AND IT DD NOT GET BETTER. THEIR OPTOMETRIST TRIED GIVING HER GLASSES, BUT THAT DID NOT HELP. THE PATIENT WAS NOT WILLING TO DO AN INTRAOCULAR LENS (IOL) EXCHANGE BUT THEY WANTED TO FIND SOLUTIONS TO THIS ISSUE. THE PATIENT WAS HAPPY WITH THE OTHER BENEFITS OF THE LENSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 18066036 ↗
• InjuryOct 17, 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 NOT ADAPTING TO MULTIFOCAL LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17950420 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER APPROXIMATELY THREE MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT ENDED UP ONE DIOPTER MYOPIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17676448 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED NIGHT TIME GLARE AND HALOS PREVENTING DRIVING AT NIGHT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AN REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS NIGHTTIME DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT WAS STILL IN POSTOP PERIOD SO FINAL OUTCOME NOT YET KNOWN.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16794017 ↗