Clareon CCWET0 (UDI 00380652405744)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652405744), received between Jan 10, 2023 and Aug 28, 2026 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, the patient had 1.25 diopters of cylindrical power postoperatively with residual astigmatism, and an explant was planned.Additional information was received stating that the patient's vision was blurry and distorted, with shadowing, difficulty reading, and trouble focusing.

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

  MAUDE report 50497414 ↗
• MalfunctionApr 21, 2026Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECTIVE HAPTIC. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943847 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FLICKERING LIGHTS AND HALOS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POSITIVE DYSPHOTOPSIA. THE LENS WAS EXPLANTED AND EXCHANGED WITH ATIOL LENS 1 MONTH FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT PATIENT WITH VISUALLY DEBILITATING PHOTOPSIAS INTERFERING WITH DAILY ACTIVITIES LIKE (READING, DRIVING, FISHING). MINIMAL SYMPTOMS ON POST OP DAY 1 POST LENS EXCHANGE AND IMPROVEMENT WITH LENS EXCHANGE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24897033 ↗
• MalfunctionMar 13, 2026Product Quality Problem

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24597930 ↗
• InjuryMar 20, 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 POOR VISUAL ACUITY AND FLICKERING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 23 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MALADAPTATION TO LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21652728 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION AND MORE ASTIGMATISM THAT EXPECTED. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 19 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20688791 ↗
• MalfunctionNov 9, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THERE WAS A SCRATCH ON LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20647129 ↗
• InjuryAug 21, 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 REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20016228 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 19826572 ↗
• InjuryJul 5, 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 VISUAL ACUITY SEEMED TO HAD A LIGHT SMOKEY HAZE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS LENS CAUSING VISUAL DISTURBANCE. ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL WITH HALF A DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19681049 ↗
• InjuryApr 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 NO DISTANCE VISION, RESIDUAL REFRACTIVE ERROR WITH HARD TIME DRIVING BOTH DAY AND NIGHT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THE PATIENT TRIED A CONTACT LENSES WITH THE RIGHT CORRECTION AS A TEST AND THE FIRST TRY WAS TERRIBLE AND VERY BLURRY.

  Patient problems: Visual Impairment

  MAUDE report 19190139 ↗
• MalfunctionApr 11, 2024Failure to Advance; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE IOL WAS INJECTED INTO PATIENT'S EYE, IT WAS STUCK TO THE INJECTOR AND CAME OUT OF THE EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19086878 ↗
• MalfunctionJan 22, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THERE WAS DEFECT/CRACK IN LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE IOL WAS EXCHANGED FOR SAME MODEL COMPANY LENS.

  Patient problems: Insufficient Information

  MAUDE report 18552225 ↗
• InjuryOct 17, 2023Adverse 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 BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MYOPIC SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17948678 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17682039 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE ERROR. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16687743 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF BLIND SPOT IN CENTER OF VISION BEGINNING ONE WEEK POST OPERATION FOR EACH EYE . THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE MISS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE FIRST EYE.

  Patient problems: Visual Impairment

  MAUDE report 16128710 ↗