Clareon CNWET0 (UDI 00380652405249)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652405249), received between Sep 8, 2022 and Jun 12, 2026 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT INJECTION ERROR WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25484677 ↗
• MalfunctionApr 17, 2026Scratched Material

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF SCRATCH ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24913736 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, HE WAS SUFFERING FROM BLUR VISION AT ALL DISTANCE. HE STILL HAS REFRACTIVE ERROR OF +0.50 SPHERICAL AND -1.5 CYLINDRICAL. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM CONSUMER STATING HE HAD SECOND OPINION. ACCORDING TO HIM, HE WAS ADVISED TO TRY SPECTACLES WITH APPROXIMATELY ±2.0 DIOPTER CORRECTION, WHICH WAS ALSO NOT WORKING SOME TIME.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24629711 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND PHOTOPSIA'S. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED MONOFOCAL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE ANOTHER LENS MODEL WITH SAME DIOPTER POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Visual Disturbances

  MAUDE report 24604690 ↗
• MalfunctionMar 6, 2026Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531411 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT OD VISION NOT DOING WELL WITH DISTANCE. IN THE SURGEON¿S OPINION VISUAL DISTORTION CAUSED THE EVENT. THE LENS WAS EXCHANGED WITH UNSPECIFIED IOL AFTER THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24471535 ↗
• MalfunctionFeb 23, 2026Break; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIFFICULTY WAS ENCOUNTERED IN MOVING THE IOL IN THE DELIVERY SYSTEM, AND HAPTIC RUPTURE WAS DETECTED. THEREFORE, IT WAS UNSUITABLE FOR IMPLANTATION. ANOTHER IOL WITH THE SAME CHARACTERISTICS WAS USED TO COMPLETE THE SURGICAL PROCEDURE. THE REPORTER STATED THAT, THE DEFECT MIGHT HAVE ORIGINATED DURING THE MANUFACTURING PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 24415877 ↗
• InjuryMay 20, 2025Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT VISION WAS NOT CRISP. THE LENS WAS SUPERIMPOSED. THE LENS WAS EXPLANTED AND EXCHANGED WITH OTHER COMPANY REPLACEMENT LENS ONE MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS UNKNOWN ETIOLOGY.

  Patient problems: Blurred Vision

  MAUDE report 22053971 ↗
• InjuryApr 23, 2025Adverse 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, PATIENT EXPERIENCED BLURRY VISUAL ACUITY AND STARBURSTS AROUND LIGHT. THE LENS WAS EXCHANGED WITH AN UNSPECIFIED LIGHT ADJUSTABLE IOL IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21888150 ↗
• MalfunctionApr 4, 2025Break; Break

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NEAR MISS. DOCTOR NOTICED A TEAR AT HAPTIC-OPTIC JUNCTION AFTER INSERTED THE LENS INTO THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND IMPLANTED THE NON COMPANY LENS. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775298 ↗
• InjuryJan 3, 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 BLURRY DISTANCE VISION AND STARBURST AROUND LIGHTS AT NIGHT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC OUTCOME. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21065115 ↗
• MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, NOTICED THAT THE HAPTIC WAS TRAILING IN THE CARTRIDGE. SURGEON WAS RELUCTANT TO USE DUE TO POSSIBLE SHEARING OFF DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20621572 ↗
• InjuryOct 3, 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 POOR DISTANCE, INTERMEDIATE, NEAR VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 2 MONTHS AND 15 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20358435 ↗
• InjuryJul 1, 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 BLURRY VISION ESPECIALLY AT DISTANCE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER 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 19643713 ↗
• MalfunctionSep 27, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REPORTER SUSPECT THAT THE INJECTORS ARE THE ONES THAT HAVE PRESENTED DEFECTS SINCE THE LENSES ARE VERIFIED BEFORE ASSEMBLY UNDER A MICROSCOPE AND AT THAT TIME NO DAMAGE HAS BEEN OBSERVED IN THE LENS UNTIL AFTER THAT THE INJECTOR HAS BEEN USED FOR IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823590 ↗
• InjurySep 26, 2023Adverse 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 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 17815688 ↗
• MalfunctionApr 23, 2023Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16792868 ↗
• InjuryApr 19, 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 SHADOWS/NAUSEA. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIS . ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Blurred Vision; Nausea; Visual Disturbances

  MAUDE report 16770505 ↗
• MalfunctionMar 21, 2023Defective Component; Device Contamination with Chemical or Other Material; Scratched Material; Defective Component; Device Contamination with Chemical or Other Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC SHORTER THAN THE OTHER ONE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE IOL HAD A SCRATCH AND APPEARED TO BE FIBERS HANGING FROM THE LENS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580610 ↗
• InjurySep 8, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO CENTRAL SCRATCHES WERE FOUND ON THE LENS. SCRATCHES WERE NOT SEEN IN THE OPERATION ROOM UNDER THE MICROSCOPE BUT WERE OBSERVED AT THE SLIT LAMP. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15376973 ↗