Clareon CCWET0 (UDI 00380652405690)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652405690), received between Aug 4, 2022 and Jan 9, 2026 — classified as 13 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION WITH GLARE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. THE LENS WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT ALSO EXPERIENCED GLARE. THE LENS WAS EXCHANGED WITH OTHER COMPANY LENS MODEL. THERE WAS NO PATIENT IMPACT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24021694 ↗
• MalfunctionSep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD A WRINKLE WHICH WAS CORRECTED BY YAG (YTTRIUM ALUMINIUM GARNET) LASER. POST THE PATIENT FELT LENS INSIDE HER EYE WAS MOVING.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 22936334 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT PATIENT EXPERIENCED VISUAL DISTURBANCE AND WORSENING VISUAL ACUITY AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT EXPERIENCED VISUAL DISTURBANCE AND CLINICAL REASON FOR EXPLANT BEING WORSENING VISUAL ACUITY AFTER IMPLANTATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) FOLLOWING THE INITIAL IMPLANT PROCEDURE. IT WAS NOTED THAT, VISUAL ACUITY HAD IMPROVED, BUT STILL HAD SOME GLARE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR RIGHT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22115560 ↗
• MalfunctionJan 30, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED AFTER IMPLANTING THE LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER SURGEON OPINION THE CARTRIDGE LIKELY CAUSED THE EVENT. SURGEON PROGNOSIS WAS UNKNOWN AND WOULD CONTINUE MONITORING THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21273267 ↗
• InjuryNov 29, 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, PATIENT WENT BACK NUMEROUS TIMES DUE TO ALL THE GLARE AND VISION DISTRACTIONS. IT HAS ACTUALLY MADE PATIENT VISION WORSE OVERALL. IT WAS BEEN TWO YEARS AND STILL NOT USED TO IT AND NOW THE OTHER EYE WAS SHOWING NEED TO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20809233 ↗
• InjuryJun 20, 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 EXPERIENCED GLARE AND HALOS DURING NIGHT TIME WHICH WAS POOR WHICH WAS EVIDENT RIGHT AFTER SURGERY. PATIENT WAS SHOCKED TO SEE THE SAME ISSUE DURING THE DAYTIME. PATIENT BELIEVED THAT THE LENS WAS NOT THE ANSWER TO NIGHT TIME GLARE. IN THE PATIENT'S CASE, IT WAS ACTUALLY WORSE. THE PATIENT WOULD PURCHASE A PAIR OF NIGHT DRIVING GLASSES AND SEE IF THAT HELPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THE FILE IS BELONGS TO THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19573627 ↗
• InjuryJan 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WANTED CORRECT LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN INTENDED TO PLACE A PARTICULAR MODEL OF THE COMPANY LENS IN THE PATIENT'S EYE BUT INSTEAD HE PLACED A DIFFERENT MODEL OF THE LENS (OTHER THAN THE PLANNED ONE) IN THE PATIENT'S EYE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH THE PLANNED LENS. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN ALSO STATED THAT, IT WOULD BE HELPFUL TO HAVE THE PACKAGING OF THE LENSES LOOK DIFFERENT. CHANGING THE NAME AND THE PACKAGING TO DISTINGUISH BETWEEN THE LENS WOULD BE HELPFUL.

  Patient problems: Insufficient Information

  MAUDE report 18423144 ↗
• InjuryNov 24, 2023Adverse 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, SEVERAL WEEKS LATER PATIENT COMPLAINED ABOUT NEAR VISION WAS TERRIBLE AND COULDN¿T READ ANYTHING WITHOUT READING GLASSES. ANOTHER SURGEON RECOMMENDED A FOLLOW UP POST-OP VISIT WITH THE SURGEON WHO PERFORMED THE SURGERY. DURING PATIENT FOLLOW UP MEETING WITH THE SURGEON, THIS WAS FIRST TIME ANYTHING WAS SAID ABOUT NEEDING READING CLASSES TO FUNCTION ON A DAILY BASIS. AFTER THE SURGERY, PATIENT HAD ¿READING GLASSES¿ SPREAD THROUGHOUT THE HOUSE, THE FARM AND BOTH VEHICLES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 2 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 18203651 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT HE HAD CATARACT SURGERY IN HIS BOTH EYES FROM 5 WEEKS AGO, CALLER STATED THAT HIS INTERMEDIATE AND NEAR VISION ARE TERRIBLE. VISION IN THE RIGHT EYE WAS 20/25 FOR DISTANCE, 20/2200 FOR CLOSE UP. HE HAD START EXPERIENCING SYMPTOMS RIGHT AFTER THE SURGERY. ALSO, STATED THAT ACCORDING TO COMPANY WEBSITE PATIENT'S CLOSE UP VISION SHOULD BE 20/30 AND INTERMEDIATE VISION SHOULD BE 20/25. THE DOCTOR TOLD THAT THE PATIENT'S CLOSE UP VISION FOR BOTH EYES WAS 20/2200. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18109893 ↗
• InjuryJul 17, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISION BLURRY CENTRALLY AND HAD TO LOOK SLIGHTLY DOWN TO SEE. THE IOL WAS EXCHANGED FOR ANOTHER LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS POSSIBLE DEFECT ON IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM, YET PATIENT STILL FELT VISION NOT CRISP CENTRALLY. PATIENT WAS DUE TO SEE THE SURGEON IN 6 WEEKS.

  Patient problems: Blurred Vision

  MAUDE report 17333565 ↗
• InjuryJun 21, 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 HAZY VISION, CLINICAL REASON BEING PSEUDOPHAKIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17170120 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED SWOLLEN AND PUFFY EYES AND HEADACHES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SYMPTOMS STILL CONTINUING, SEEING ALLERGIST TO DO PATCH TESTING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 2.

  Patient problems: Corneal Edema; Headache

  MAUDE report 16476317 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED SWOLLEN AND PUFFY EYES AND HEADACHES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SYMPTOMS ARE CONTINUING, SEEING ALLERGIST TO DO PATCH TESTING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 2 OF 2.

  Patient problems: Corneal Edema; Headache

  MAUDE report 16476271 ↗
• InjurySep 30, 2022Adverse 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, THE PATIENT COULD NOT READ AND DISTANCE VISION WAS 20/60. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND STATED THAT, THE PATIENT HAD HEADACHE ALSO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Headache; Visual Impairment

  MAUDE report 15518604 ↗
• InjuryAug 4, 2022Defective Device; Defective Device

  A DOCTOR REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), WHEN THE INFERIOR HAPTIC GRABBED ON TO THE CAPSULE AND TOOK THE CAPSULE OUT WHILE REMOVING VITREOUS. THE PATIENT HAD HEMORRHAGING FOR A COUPLE WEEKS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15163897 ↗