Clareon CCWTT3 (UDI 00380652457361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652457361), received between Oct 17, 2022 and Aug 10, 2026 — classified as 11 injuries, 3 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Scratched Material

  A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed scratch after the IOL was implanted into the eye. The lens was explanted during initial procedure. Additional information has been requested and received by stating, a foldable intraocular lens was placed from the package into the inserter. A 19.0 diopter company lens was placed in the capsular bag and rotated to 10 degrees. There was a scratch in the center of the lens. The ring was removed. The lens was removed, cut out of the eye. Iris hooks were placed and the lens was removed. The main wound was widened. A new company lens of same model and diopter was used and placed in the bag and no scratch was seen. The iris hooks were removed. Two 10.0 nylon sutures were used due to the main wound widening.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195028 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, she had experienced blurred vision and halos after surgery and was unhappy with her vision. A yttrium aluminum garnet (YAG) laser procedure had been performed on the right eye (OD); however, her vision remained blurred.There are two medical reports associated with this patient. This file belongs to right eye.Additional information has been requested but no information is available at the time of this report.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50176474 ↗
• InjurySep 10, 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 HALOS WITH LIGHTS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS HALOS AND DECREASED CONTRAST SENSITIVITY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT NOTICED DECREASED SHARPNESS IN IMAGES IN THE POST OPERATIVE EYE DESPITE TRYING TO REFRACT LEFT EYE. THE LENS WAS REPLACED WITH SAME COMPANY MODEL AND DIOPTER LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23015111 ↗
• MalfunctionJul 18, 2025Optical Decentration; Optical Decentration

  A NURSE REPORTED THAT FOLLOWING AN FEMTO-ASSISTED CATARACT EXTRACTION (CE) SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A DISLOCATED LENS. THE CLINICAL REASON FOR EXPLANT WAS DISLOCATED IOL IN THE LEFT EYE. THE IOL (LENS 1) WAS WELL CENTERED AT THE END OF THE CASE. APPROXIMATELY 1 METER POST-OP, THE PATIENT WAS REFERRED BACK WITH SUBOPTIMAL VISUAL ACUITY (VA). THE IOL WAS NOTED TO BE NASALLY DECENTERED BY APPROXIMATELY 2 MILLIMETERS (MM), AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR), WHERE THE IOL COULD NOT BE RE-CENTERED. THE IOL WAS LIFTED INTO THE ANTERIOR CHAMBER (AC), AND ONE HAPTIC WAS FOUND TO BE MISSING. THE AMPUTATED HAPTIC WAS NOT RETRIEVED OR SEEN. THE IOL WAS EXPLANTED AND REPLACED WITH A SAME MODEL, SAME DIOPTER, SAME COMPANY IOL (LENS 2), WHICH WAS ALSO FOUND TO BE DECENTERED ON POST-OPERATIVE DAY 1 (POD 1), PRESUMABLY DUE TO THE REMAINING HAPTIC IN THE BAG. THE PATIENT'S ISSUES HAD NOT YET RESOLVED. THE SURGEON GAVE A GOOD PROGNOSIS. IN THE SURGEON'S OPINION, THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22541405 ↗
• InjuryJul 4, 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, PATIENT EXPERIENCED CLOUDINESS AND BLURRINESS IN THE LEFT EYE ONCE THE IOL WAS INSERTED, ALSO STARTED EXPERIENCING SOME ISSUES WITH THE RIGHT LENS, INCLUDING OCCASIONAL BLURRINESS WHILE READING UP CLOSE ¿ SOMETIMES IT IS BLURRY AND SOMETIMES IT IS CLEAR. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAS BEEN EXPERIENCING FLUCTUATING VISION IN THE LEFT EYE SINCE UNDERGOING CATARACT SURGERY ON (B)(6) 2025. HE REPORTED INTERMITTENT CLOUDINESS, DIFFICULTY READING FINE PRINT, AND A SENSATION SIMILAR TO HAVING A GRAIN OF SAND IN THE EYE. THE PATIENT IS CURRENTLY USING VASOCONSTRICTOR + ANTIHISTAMINE COMBINATION DROPS AS PRESCRIBED BY HIS SURGEON. HE ALSO MENTIONED THAT HE WAS ABLE TO READ THE SERIAL NUMBERS FROM THE IMPLANT CARDS AND OBSERVED THAT HIS VISION IMPROVES WHEN EXPOSED TO BRIGHTER LIGHT FROM THE WINDOWS IN HIS HOME.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Impairment

  MAUDE report 22403688 ↗
• InjuryJun 20, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WAS DISLOCATED LENS. CLINICAL REASON FOR EXPLANT WAS DISLOCATED IOL LEFT EYE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 01 MONTH 12 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 22302074 ↗
• InjuryMay 30, 2025Break; Optical Decentration; Break; Optical Decentration

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 07 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS CRACKED HAPTIC UPON IMPLANTATION CAUSING IOL DECENTRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22114742 ↗
• InjuryNov 28, 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 BLURRED VISION, HAZY AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS 7 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL DEFECT. ADDITIONAL INFORMATION PROVIDED, THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20805832 ↗
• 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 ATIOL LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20143294 ↗
• InjuryJan 8, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED POOR VISION, CONTRAST DEFINITION . CLINICAL REASON WAS MENTIONED AS DEFECTIVE IOL.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING 1 MONTH 25 DAYS THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

  Patient problems: Visual Impairment

  MAUDE report 18463657 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION QUALITY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT IS POOR SUBJECTIVE VISION.

  Patient problems: Visual Impairment

  MAUDE report 18180612 ↗
• 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, PLANNED FOR LENS EXPLANT TO MONOFOCAL . ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 17258049 ↗
• InjuryJan 6, 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 LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO THE PATIENT WAS STILL EXPERIENCING DISTANCE BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND THE ISSUES HAVE RESOLVED. THE PROGNOSIS WAS GOOD.

  Patient problems: Blurred Vision

  MAUDE report 16110841 ↗
• MalfunctionOct 17, 2022Defective Device; Defective Device

  A FACILITY REPORTED DEFECTIVE LENS VIA REPLY CARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15619500 ↗