Clareon CCWTT0 (UDI 00380652413701)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652413701), received between Dec 20, 2022 and Sep 12, 2026 — classified as 30 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50745746 ↗
• MalfunctionJun 10, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE FRONT HAPTIC WAS BROKEN IN THE CARTRIDGE, WHICH WAS NOT A NORMAL OCCURRENCE. THE SURGEON DID NOT HAVE ANY CONCERNS WITH THE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT WHILE PRELOADING FRONT HAPTIC BROKE IN CARTRIDGE WITH NO PATIENT CONTACT. IN THE SURGEON'S OPINION, THE IOL WAS TOO LONG IN COMPANY CARTRIDGE OR BY THE WAY IT WAS GRASPED WITH COMPANY FORCEPS PRIOR TO LOADING IN THE CARTRIDGE CAUSED OR CONTRIBUTED TO THE EVENT. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455924 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND DISTANCE VISION NOT CLEAR. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH AN NONCOMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER SUBJECTIVE VISUAL DISTURBANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S ISSUE HAS BEEN RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25407477 ↗
• InjuryFeb 27, 2026No Apparent Adverse Event

  A NON-HEALTHCARE PROFESSIONAL REPORTED AN INTRAOCULAR LENS (IOL) EXCHANGE WITH AN UNSPECIFIED ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE REASON FOR EXPLANT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24469983 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DIPLOPIA AND ANISOMETROPIA. 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: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 24178016 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PLANNED IOL EXPLANT WITH THE REASON: PATIENT STATES DIFFICULTY DRIVING AT NIGHT DUE TO GLARE AND EVERYTHING JUST SEEMS BLURRY. PATIENT IS SCHEDULED FOR IOL EXCHANGE ON (B)(6). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SURGEON ATTEMPTED AN INTRAOCULAR LENS (IOL) EXCHANGE; HOWEVER, AN ANTERIOR CHAMBER (AC) TEAR OCCURRED DURING THE PROCEDURE. AS A RESULT, THE ORIGINAL IOL WAS NOT EXPLANTED. THE PLANNED REPLACEMENT LENS POWER WAS 22.0 D.

  Patient problems: Blurred Vision; Capsular Bag Tear; Visual Disturbances

  MAUDE report 24144476 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENTS VISION AT DISTANCE WAS POOR. SHE COULD SEE TO READ AND SEW, BUT ANYTHING BEYOND AROUND 15 FEET WAS BLURRED. SHE BARELY PASSED THE DRIVING TEST. SHE HAD BEEN GIVEN A GLASSES PRESCRIPTION, AND HER BCVA WAS 20/50. THE PATIENT STATED SHE HAD SEEN TWO DOCTORS IN THE PRACTICE, AND THEY COULD NOT PROVIDE HER WITH ANY SOLUTIONS. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 24004357 ↗
• InjuryOct 21, 2025Adverse 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 EXPERIENCED INTOLERANCE TO MULTIFOCAL LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DISTANCE VISION INSUFFICIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LENS WAS EXCHANGED WITH ANOTHER COMPANY LENS, THIS EXTRA SURGERY WORSENED DRY EYES. THE PATIENT WAS STRUGGLING WITH DRY EYES.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23346673 ↗
• InjurySep 25, 2025Adverse 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 EXPERIENCED INTOLERANCE TO MULTIFOCAL LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DISTANCE VISION INSUFFICIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LENS WAS EXCHANGED WITH ANOTHER COMPANY LENS, THIS EXTRA SURGERY WORSENED DRY EYES. THE PATIENT WAS STRUGGLING WITH DRY EYES.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23141141 ↗
• InjuryAug 11, 2025Adverse 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 UNABLE TO ADAPT TO MULTIFOCAL LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22771363 ↗
• 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 PATIENT 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. DUE TO COMPLEX SURGERY, THE PATIENT HAD SLOWER HEALING TIME (LOOSE ZONULES + IRIDODIALYSIS). THE PATIENT¿S ISSUES RESOLVED HOWEVER HAVING LIGHT SENSITIVITY DUE TO IRIDODIALYSIS. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22608779 ↗
• InjuryJul 1, 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 BLURRY VISION AND GLARE. THE IOL WAS EXPLANTED AND EXCHANGED WITH UNSPECIFIED LENS OF DIFFERENT MODEL IN THE SECONDARY IMPLANT PROCEDURE. THE PATIENT'S EVENTS WERE RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22371141 ↗
• InjuryJun 20, 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 BLURRY VISION AT A DISTANCE AND CLINICAL REASONS FOR MALADAPTATION. APPROXIMATELY 1 MONTH, 3 WEEKS, AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR A LIGHT ADJUSTABLE LENS MODEL.

  Patient problems: Blurred Vision

  MAUDE report 22301765 ↗
• MalfunctionMay 20, 2025Product Quality Problem; Product Quality Problem

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

  Patient problems: Insufficient Information

  MAUDE report 22054257 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) THE PATIENT HAD EXPERIENCED UNTOLERABLE LENS. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22008674 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD INTOLERABLE DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR AN UNSPECIFIED MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH NON-COMPANY LENS OF DIFFERENT DIOPTER.

  Patient problems: Visual Disturbances

  MAUDE report 22002442 ↗
• InjuryMar 20, 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 AT ALL DISTANCES, FOGGY VISION AND STARBURST. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY MONOFOCAL LENS MODEL LENS 9 MONTHS AND 15 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS THE PATIENT WAS UNSATISFIED. THE PATIENT UNDERWENT YAG LASER PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21652397 ↗
• InjuryFeb 18, 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. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTHS AND 25 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS IOL CAME TOO STRONG. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21400163 ↗
• InjuryFeb 11, 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 VISION WAS TERRIBLE AND WORSE. PATIENT EXPERIENCED BLURRY DISTANCE VISION AND WAS NOT ABLE TO READ THE TV AND COULDN'T READ PHONE. SHE HAD PAIN BEHIND EYE. SHE WAS ALSO EXPERIENCED HALOS AND HAD LIGHT SENSITIVITY. SHE DEVELOPED SCAR TISSUE IMMEDIATELY AFTER THE SURGERY AND DID HAVE SCAR TISSUE REMOVAL. THE PATIENT WAS UNDER TREATMENT WITH ANTIBIOTICS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Pain; Headache; Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 21354957 ↗
• MalfunctionFeb 3, 2025Break; Break

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC BROKEN. ADDITIONAL INFORMATION RECEIVED STATING THAT WHEN INSERTING THE LENS HAPTIC BROKE OFF IN THE EYE DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296030 ↗
• InjuryNov 5, 2024Adverse 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 WITH RINGS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 08 MONTHS 08 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 20608624 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE DYSPHOTOPSIAS AND RING DISTORTION THAT IMPAIRED SAFE DRIVING AND QUALITY OF LIFE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 09 MONTHS 05 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT NON ADAPT AFTER 9 MONTHS. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Visual Disturbances

  MAUDE report 20462740 ↗
• InjurySep 18, 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 EXPERIENCED POOR DISTANCE VISION, GLARE, HALOS AND NO CONTRAST. SO, THE LENS WAS EXCHANGED WITH ANOTHER COMPANY LENS.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20245607 ↗
• MalfunctionSep 18, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AFTER IMPLANTATION IN EYE, PHYSICIAN NOTICED THE LENS HAD AN OFF-AXIS SCUFF THAT PHYSICIAN COULDN'T ATTRIBUTE TO ANYTHING. PHYSICIAN DON'T BELIEVE IT WILL AFFECT THE PATIENT'S VISION AT ALL AS IT IS VERY FAINT AND OFF-AXIS. PHYSICIAN CHOSE NOT TO EXCHANGE THE LENS DUE TO THE FINE NATURE OF THE SCUFF AND THE OFF-AXIS POSITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244715 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT COMPLAINED OF FOGGY VISION SINCE POST OPERATIVE WEEK#3. REASSURANCE AND HANDHOLDING PROVIDED. PHOTOREFRACTIVE KERATECTOMY (PRK) PERFORMED AT POST OPERATIVE MEETING#6 FOR RESIDUAL +0.50. POSTERIOR CAPSULE CLEAR, OBJECTIVE SCATTER INDEX (OSI) ELEVATED. VISION DID NOT IMPROVE, PATIENT REPORTED VISION FOGGY AT DISTANCE AND NEAR. THE PATIENT ISSUES RESOLVED POST SECONDARY LENS EXPLANTATION.

  Patient problems: Blurred Vision

  MAUDE report 20237610 ↗