Clareon CCWTT3 (UDI 00380652457385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652457385), received between Apr 11, 2023 and Jul 10, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 10, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED DECAPITATED HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25778716 ↗
• MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT UPON INSERTION TO LOADER WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING LOADING THE TRAILING HAPTIC WAS BENT AND LENS REMAINED IN DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774113 ↗
• InjuryMar 28, 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, PATIENT VISION WAS NOT CLEAR, COULD NOT SEE TO DRIVE AT NIGHT DUE TO HALOS, DRY EYES, SCRATCHY, HEADACHE. THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Eye Irritation; Headache; Visual Disturbances

  MAUDE report 21717690 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL WITH TWO 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

  MAUDE report 21158655 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS, HIS VISION WAS BLURRY AT ALL DISTANCES, HAS STREAKS OF LIGHT AT NIGHT/ SEES STARBURSTS AT NIGHT. ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER STATING FROM LAST FEW DAYS HIS VISION HAS GONE BLURRY IN THE UPPER RIGHT QUADRANT, LIKE THE FACE OF A CLOCK. THE SYMPTOMS ARE ONGOING AT THE TIME OF FOLLOW UP REPORT. FURTHER ADDITIONAL INFORMATION WAS REPORTED BY THE CONSUMER STATING HE HAD LASER AND A GAS BUBBLE ON HIS OD FOR A RETINAL DETACHMENT (RD). HE ALSO FOUND OUT HIS CATARACT SURGEON DID NOT PUT THE LENS IN THE CAPSULAR BAG BUT IN FRONT OF THE BAG. HE WAS TOLD CATARACT SURGERY COULD INCREASE THE RISK FOR RD.

  Patient problems: Blurred Vision; Loss of Vision; Retinal Detachment; Visual Disturbances

  MAUDE report 20793159 ↗
• InjuryOct 24, 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 GLARE, HALOS, POOR CONTRAST, PERIPHERAL VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 22 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS UNABLE TO TOLERATE VISION WITH IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20521545 ↗
• 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20143293 ↗
• InjuryJul 22, 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 HALOS AT NIGHT. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HYPEROPIC MISS RIGHT EYE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 19791809 ↗
• InjuryMar 13, 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 CANNOT SEE WELL WITH LENS. THE CLINICAL REASON WAS REPORTED AS POOR VISION WITH IOL. DUE TO POOR VISION THE IOL WAS EXCHANGED FOR ANOTHER SINGLE MONOFOCAL IOL MODEL AFTER 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. THE LENS WAS EXCHANGED WITH A NON COMPANY IOL.

  Patient problems: Visual Impairment

  MAUDE report 18892783 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION BOTH AT NEAR AND DISTANCE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS UNABLE TO CORRECT BETTER THAN 20/50. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18875486 ↗
• InjuryDec 22, 2023Adverse 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 WAS NOT ABLE TO SEE OUT OF LENS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT BEST CORRECTED VISION WAS 20/50 AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT AFTER SURGERY PATIENT NEVER SAW 20/50. IN THE SURGEON¿S OPINION PATIENT WAS NOT TOLERABLE TO DIFFRACTIVE IOL.

  Patient problems: Blurred Vision

  MAUDE report 18383862 ↗
• InjuryOct 23, 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. THE IOL WAS EXCHANGED FOR ANOTHER LENS 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS HYPEROPIC MISS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, AS PER SURGEONS OPINION, THE IOL WAS THE CAUSE FOR THE EVENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17983291 ↗
• InjurySep 1, 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 DISSATISFIED WITH THE LENS. HE COULD NOT SEE THE GOLF BALL, HAS FLOATERS, FEELS PRESSURE AROUND EYE, CONSTANTLY WEEPING, BLOODSHOT AND BLURRED. HE HAS SEEN AN OPTOMETRIST AND WAS TOLD HIS EYE LOOK FINE. HE HAS AN APPOINTMENT TO SEE SURGEON IN NOVEMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Conjunctivitis; Discomfort; Excessive Tear Production; Halo; Hyperemia; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 17668981 ↗
• InjurySep 1, 2023Adverse 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 HAVE INTENSE DISPLEASURE WITH THE LENS, PINK SCLERA, BLURRED VISION, AND INABILITY TO DRIVE AT NIGHT DUE TO INTENSITY OF CAR HEADLIGHTS. HE IS GOING TO REQUEST SURGEON FOR THE COMPANY LENS TO BE REMOVED AND REPLACE WITH THE BASIC ACCOMMODATIVE TORIC LENS IN THE UPCOMING APPOINTMENT.

  Patient problems: Blurred Vision; Conjunctivitis; Discomfort; Visual Impairment; Vitreous Floaters

  MAUDE report 17668980 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT STATES IT LOOKS LIKE SHE IS LOOKING THROUGH OIL AND HAS FLICKERING. THE IOL WAS REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17378936 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. PATIENT COULD NOT DRIVE AT NIGHT, PATIENT HAD DRY EYES SINCE SURGERY AND HAD TRIED CALCINEURIN INHIBITOR IMMUNOSUPPRESSANTS AND CORTICOSTEROIDS WITH NO HELP. ADDITIONAL INFORMATION WAS REQUESTED

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

  MAUDE report 17255603 ↗
• MalfunctionApr 25, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16805438 ↗
• InjuryApr 14, 2023Adverse 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 LENS WAS EXPLANTED DUE TO PATIENT HAD A DECREASED VISION. THE IOL WAS EXCHANGED FOR ATIOL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16742149 ↗
• InjuryApr 11, 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 HAD DECREASED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 16713968 ↗