Clareon CCWTT0 (UDI 00380652413725)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652413725), received between Apr 5, 2023 and Mar 24, 2026 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE LENS WHILE POLISHING AFTER INSERTION. PER THE MEDICAL DOCTOR, THE LENS WAS LEFT IMPLANTED IN THE PATIENT. THE SCRATCH WAS LOCATED ON THE EDGE OF THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24672666 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED, AND IT STATES THAT IN THE SURGEON¿S OPINION MOST LIKELY VITAMIN B12 DEFICIENCY CAUSED THE EVENT. LENS WAS EXPLANTED AND REPLACED WITH NON-COMPANY LENS WITHOUT NO FURTHER HARM TO THE PATIENT. ISSUE WITH THE VISION REMAINS THE SAME AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: Visual Impairment

  MAUDE report 23789231 ↗
• 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 VISION. CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR LIGHT ADJUSTABLE LENS PLUS 07 MONTHS 08 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22940658 ↗
• InjuryAug 8, 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 AT DISTANCE, NOT SHARP AT INTERMEDIATE AND NEAR VISIONS, DIFFICULTY WITH GLARE AND HALOS AT NIGHT AND DECREASED DEPTH PERCEPTION THAT CAUSED HEADACHES AND INABILITY TO PERFORM ACTIVITIES OF DAILY LIFE. CLINICAL REASON FOR EXPLANTATION IS INTOLERANCE TO MULTIFOCAL TECHNOLOGY. THE IOL WAS EXCHANGED FOR ANOTHER MODEL SAME DIOPTER SAME COMPANY LENS 2 MONTHS 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT REPORTED DEBILITATING VISUAL QUALITY, ATTRIBUTING TO HEADACHES AND IMBALANCE DUE TO DEPTH POOR DEPTH PERCEPTION. WAS UNABLE TO DRIVE, READ AND WORK.

  Patient problems: Blurred Vision; Dizziness; Headache; Visual Disturbances; Visual Impairment

  MAUDE report 22749696 ↗
• 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 THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY AT DISTANCE VISION. THE IOL WAS REPLACED WITH AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 1 MONTH AND 4 DAYS AFTER THE INITIAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22609025 ↗
• MalfunctionMar 14, 2025Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD DEFECTIVE AND DID NOT USE.

  Patient problems: Insufficient Information

  MAUDE report 21613032 ↗
• MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRACKED AS SHE WENT TO INSERT IT. THEY LOST THE LENS WHEN SHE WAS TAKING IT OUT. ADDITIONAL INFORMATION HAS RECEIVED THAT THE LENS INSERTED AND REMOVED DURING INITIAL PROCEDURE AND SCHEDULED PROCEDURE COMPLETED THE SAME DAY WITH BACKUP LENS THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 21354214 ↗
• MalfunctionNov 14, 2024Failure to Eject; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS STUCK IN MAIN WOUND, WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682384 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT THE LENS WAS EXCHANGED FOR AN UNKNOWN INTRAOCULAR LENS, 1 MONTHS AND 15 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE REASON WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAD BLURRY VISION. THE CLINICAL REASON FOR EXPLANT WAS LOW CONTRAST AND DYSPHOTOPSIA. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAD BLURRY WAXY VISION, POOR UNCORRECTED AND BEST CORRECTED VISION. THE LENS WAS EXCHANGED WITH NON-COMPANY IOL. THE PATIENT'S OUTCOME WAS RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 20521481 ↗
• InjurySep 26, 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 REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS NEEDED CYLINDER CORRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20310578 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20134420 ↗
• 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. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20133402 ↗
• InjuryAug 2, 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 WAS BOTHERED BY HALOS AND STARBURSTS AROUND LIGHTS. CLINICAL REASON FOR EXPLANT WAS HYPEROPIC MISS. THE IOL WAS EXCHANGED FOR NON-COMPANY ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 10 MONTHS 9 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT PATIENT EXPERIENCED GLARE, LIGHT SENSITIVITY AND BLURRY VISION. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19890538 ↗
• InjuryMar 29, 2024Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT AFTER AN INTRA-OCULAR LENS (IOL) PROCEDURE, POST-OPERATIVELY DEMONSTRATED AN IN-THE-BAG DISLOCATION OR DECENTRATION OF THE IOL. THE LENS WAS CENTERED WELL AT THE CONCLUSION OF THE CASE. IT WAS REPORTED THAT PATIENT HAD DEVELOPED IFIS WITH PROGRESSIVE MIOSIS INTRA-OPERATIVELY. WHEN THE DECENTRATION WAS DIAGNOSED IN CLINIC, IT WAS DIFFICULT TO SEE THE CAUSE. THE PHYSICIAN TOOK HIM BACK TO THE OPERATING ROOM. AT THE TIME OF THE IOL RE-POSITION IT WAS NOTED THAT ONE OF THE HAPTICS WAS TUCKED/STUCK TO THE OPTIC AND WOULD NOT FULLY EXTEND. RELEASING THE HAPTIC AT THE TIME OF REPOSITION WAS NOT CURATIVE AS THE HAPTIC WAS NOT OBSERVED TO FULLY EXTEND. THE PHYSICIAN STRETCHED IT OUT. THE PATIENT AGAIN HAD IFIS WHILE REPOSITIONING, SO THE PHYSICIAN COULD NOT CONFIRM THE HAPTIC POSITION AT THE CONCLUSION OF THE CASE BUT WAS CONFIDENT THAT THE OPTIC WAS BETTER CENTERED. POST-OPERATIVELY, THE PATIENT AGAIN HAS A MILDLY DECENTERED OPTIC COMPARED TO THE FELLOW EYE. THE PHYSICIAN THOUGHT THE HAPTIC WAS DEFECTIVE BEYOND REPAIR AND DECIDED THE LENS NEEDED TO BE REPLACED. THE LENS WILL BE EXPLANTED. IN PHYSICIAN'S OPINION, THE HAPTIC WAS COMPRESSED DURING INSERTION AND FORME

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

  MAUDE report 19002574 ↗
• InjuryFeb 9, 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 LEFT EYE.

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

  MAUDE report 18674277 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD FLICKERING LIGHTS IN PERIPHERY, BLURRY UNCORRECTED VISION AT NEAR MORE THAN DISTANCE AND FUZZY. THE IOL WAS EXCHANGED FOR ANOTHER DIOPTER AND MODEL COMPANY LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18569265 ↗
• InjuryDec 27, 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 EXPERIENCED SEVERE GLARE. CLINICAL REASON BEING SEVERE GLARE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 18397190 ↗
• InjuryNov 16, 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 EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS NOT ENOUGH POWER TO LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18147206 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS, DISTANCE VISION WAS BLURRY AND WAS OUT OF FOCUS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT. THE PATIENT ISSUES HAVE RESOLVED AND THE PROGNOSIS WAS GOOD.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16681245 ↗