Clareon CCWTT0 (UDI 00380652413688)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652413688), received between Jul 15, 2022 and Jun 10, 2026 — classified as 31 injuries, 4 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 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 VISUAL ACUITY ISSUES AND RINGS/HALOS. THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED MONOFOCAL IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25456078 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED PROBLEMS WITH VISION. CLINICAL REASON FOR EXPLANT SUBJECTIVE VISUAL/DISTURBANCES. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS 62 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM AND IN SURGEON OPINION PRODUCT DID NOT CONTRIBUTE TO THE EVENT. IT WAS STATED THE PATIENT'S ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 25410003 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT HAD EXPERIENCED RINGS. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE PATIENT WAS NOT SATISFIED. THE IOL WAS REPLACED WITH UNSPECIFIED LIGHT ADJUSTABLE LENS 8 MONTHS 29 DAYS AFTER INITIAL PROCEDURE. 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 RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24441891 ↗
• InjuryOct 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 VISION DID NOT IMPROVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS.

  Patient problems: Blurred Vision

  MAUDE report 23356558 ↗
• InjurySep 2, 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 DISTANCE VISUAL ACUITY. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 21 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22936283 ↗
• InjuryJul 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 WITH BLURRED VISION, DISTANCE AND NEAR VISION, INTOLERABLE RAYS AROUND LIGHTS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 23 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INTOLERABLE DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22402891 ↗
• InjuryJun 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) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR NON COMPANY LENS MODEL 3 MONTHS AND 9 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS ASTIGMATISM. THE PATIENT UNDERWENT ASTIGMATISM LIMBAL RELAXING INCISIONS PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22327878 ↗
• InjuryJun 17, 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 GLARE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THERE WAS NO PATIENT HARM. THE SURGEON'S PROGNOSIS WAS BRIGHT LIGHT WAS STILL BOTHERSOME AND VISION WAS UNCLEAR AND POSTERIOR CAPSULE OPACIFICATION. HENCE YTTRIUM ALUMINIUM GARNET LASER WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SHE WAS DOING GREAT POST EXCHANGE. NO COMPLAINTS ISSUES WITH BRIGHT LIGHTS/HALOS AND BLURRED VISION WAS CORRECTABLE WITH THE PATIENT'S NEW GLASSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 22235524 ↗
• InjuryJun 12, 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 WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22195369 ↗
• InjuryMay 16, 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 COULDN'T ADAPT TO VISION IT LOOKED LIKE SHE WAS LOOKING THROUGH BUTTER. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SYMPTOMS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 22034701 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS DENSE POSTERIOR CAPSULAR OPACIFICATION, GRADE 2 ANTERIOR CAPSULE FIBROSIS AND LENS ROTATION AT FIVE WEEKS POST OPERATION. ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATING THAT GRADE 1 PCO AND GRADE 2 ACF AT SEVEN WEEKS POST OPERATION. PATIENT WAS PRESCRIBED OPHTHALMIC EYE DROP AS POSTOPERATIVE MEDICATION CONTAINING COMBINATION OF CORTICOSTEROID, BROAD-SPECTRUM ANTIBIOTIC AND NON-STEROIDAL ANTI-INFLAMMATORY DRUG. YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY PERFORMED. IN THE SURGEON¿S OPINION THE PRODUCT CONTRIBUTES TO THE EVENT.

  Patient problems: Blurred Vision; Inflammation; Posterior Capsule Opacification

  MAUDE report 22024564 ↗
• InjuryApr 10, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS DENSE POSTERIOR CAPSULAR OPACIFICATION, GRADE 2 ANTERIOR CAPSULE FIBROSIS AND LENS ROTATION AT FIVE WEEKS POST OPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Inflammation; Posterior Capsule Opacification

  MAUDE report 21814782 ↗
• MalfunctionJan 27, 2025Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH OR MARK ON OPTIC / BLEMISH/INDENTATION/SCUFF MARK/SCORE MARK ON OPTIC WAS NOTICED AFTER IMPLANTATION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE DUE TO DEFECT. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 21239500 ↗
• MalfunctionJan 13, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT BOTH THE FRONT AND BACK HAPTICS BROKE OFF THIS LENS UPON INSERTION. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL DURING INITIAL PROCEDURE. THE SURGEON BELIEVES IT TO BE A LOADING ERROR .THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21135732 ↗
• InjuryDec 3, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD WAXY VISION AND OVERALL POOR QUALITY VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT WAS COMPLAINED OF FOGGY VISION SINCE POST OPERATIVE WEEK ONE. POSTERIOR CAPSULE WAS CLEAR BUT OPTICAL SCATTER INDEX (OSI) ELEVATED. PATIENT'S NEAR AND DISTANCE VISON WAS GOOD, BUT VISION WAS OF POOR QUALITY AND WAXY IN NATURE. IN SURGEON'S OPINION PRODUCT CONTRIBUTED TO THE EVENT. PATIENT'S ISSUE WAS RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20829320 ↗
• InjuryOct 30, 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 HAD A REFRACTIVE ERROR. CLINICAL REASON BEING MENTIONED AS HYPEROPIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20570936 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPERIENCED HALOS AT NIGHT AND UNABLE TO DRIVE AT NIGHT DUE TO THE HALOS. ALSO SEEKING A SECOND OPINION AND MAY HAVE LENS REMOVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo

  MAUDE report 20554595 ↗
• InjurySep 12, 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 STATED ABILITY TO READ WAS OKAY BUT DISTANCE VISION WAS NOT GOOD. UNABLE TO READ ROAD SIGNS OR SEE TV. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS NON-ADAPT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20201266 ↗
• 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 4 MONTHS AND 18 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20136506 ↗
• 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 20134418 ↗
• 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 20134409 ↗
• InjuryJun 12, 2024Adverse 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 WAS DISSATISFIED WITH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD DIFFICULTY TO READ AND COLD NOT SEE FAR AS WELL AS EXPECTED.

  Patient problems: Blurred Vision

  MAUDE report 19518033 ↗
• InjuryMay 16, 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 EXPERIENCED INABILITY TO ADAPT TO HALOS, TROUBLE WITH DEPTH PERCEPTION AND CLINICAL REASON FOR EXPLANT BEING INABILITY TO ADAPT TO HALOS, TROUBLE WITH DEPTH PERCEPTION. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SYMPTOMS WAS RESOLVED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19329050 ↗
• InjuryApr 16, 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 EXPERIENCED FATIGUE FROM TRYING TO FOCUS ON DESKTOP COMPUTER AND EYE STRAIN WITH IPAD. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HYPEROPIC MISS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Dizziness; No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 19114327 ↗
• InjuryApr 1, 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, PATIENT EXPERIENCED HAZY VISION AND BOTHERED BY HALOS. THE IOL WAS EXCHANGED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT EXPERIENCED SENSITIVE TO REFLECTION AND THERE WAS NO PATENT HARM.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions; Visual Disturbances; Visual Impairment

  MAUDE report 19010460 ↗