Clareon CNWET0 (UDI 00380652405300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652405300), received between Jan 31, 2023 and Jun 26, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS APPEARED SCRATCHED IN THE LENS-TO-EYE INJECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED BY STATING, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637931 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DUE TO INTOLERABLE SIDE EFFECT, THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 25328620 ↗
• MalfunctionNov 21, 2025Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR IMPLANT LENS PROCEDURE, LENS WAS DETECTED AS DAMAGED AND DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE LENS WAS CLAMPED DUE TO AN INCORRECT POSITION IN THE CONTAINER AND DURING ADVANCING AN IOL INTO THE CARTRIDGE AT THE STAGE OF IMPLANTATION A DEFECT IN THE HAPTIC ELEMENT WAS REVEALED.

  Patient problems: Insufficient Information

  MAUDE report 23617428 ↗
• MalfunctionSep 25, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23144329 ↗
• InjuryAug 7, 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 SAME LENS MODEL BUT ONE AND A HALF DIOPTER LESS 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 22738304 ↗
• MalfunctionMar 20, 2025Product Quality Problem; Product Quality Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE THE LENS WAS FAULTY. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21652254 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS UNEXPLAINED POOR OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21374023 ↗
• InjuryNov 12, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER SURGERY, LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO PATIENT HAD SEVERE BLURRING OF LIGHT, AND DURING THE ONE-WEEK FOLLOW-UP, FINE SCRATCHES OCCURRED ON THE OPTIC. THE IOL WAS REPLACED WITH UNSPECIFIED LENS AT ANOTHER HOSPITAL.

  Patient problems: Blurred Vision

  MAUDE report 20667758 ↗
• MalfunctionOct 22, 2024Scratched Material; Scratched Material

  A CONSUMER REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN USING THE COMPANY INJECTOR TO PLACE THE LENS, LENS WAS SCRATCHED, AND NOTCHED ON BOTH PERIPHERY AND CENTER AREA. THE LENS WAS BROKEN INTO HALF AND EXPLANTED. REPLACED WITH BACK UP COMPANY LENS WITH UNSPECIFIED DIOPTER DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20508190 ↗
• MalfunctionJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, ALL THREE IOLS DISPLAYED A TEAR ON THE PERIPHERAL EDGE. THE PATIENT HAD TO HAVE TWO LENSES EXPLANTED IN AN INITIAL PROCEDURE, AS THE SURGEON WAS NOT HAPPY WITH THE INTEGRITY OF THE LENS AND EVEN THOUGH THE THIRD LENS ALSO SHOWED AN IMPERFECTION THE SURGEON FELT THAT IT WOULD NEGATIVELY IMPACT THE VISUAL OUTCOME FOR THE PATIENT SO DECIDED TO COMPLETE THE SURGICAL PROCEDURE. DIFFERENT INJECTORS WERE UTILIZED FOR ALL THREE LENSES BEING IMPLANTED WITH THE SAME RESULT. TWO OF THE THREE SURGICAL CASES UTILIZED A COMPANY D CARTRIDGE FOR LENS LOADING AND A COMPANY C CARTRIDGE WAS UTILIZED FOR ONE CASE WITH THE SAME OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19681047 ↗
• MalfunctionJul 5, 2024Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, ALL THREE IOLS DISPLAYED A TEAR ON THE PERIPHERAL EDGE. THE PATIENT HAD TO HAVE TWO LENSES EXPLANTED IN AN INITIAL PROCEDURE, AS THE SURGEON WAS NOT HAPPY WITH THE INTEGRITY OF THE LENS AND EVEN THOUGH THE THIRD LENS ALSO SHOWED AN IMPERFECTION THE SURGEON FELT THAT IT WOULD NEGATIVELY IMPACT THE VISUAL OUTCOME FOR THE PATIENT SO DECIDED TO COMPLETE THE SURGICAL PROCEDURE. DIFFERENT INJECTORS WERE UTILIZED FOR ALL THREE LENSES BEING IMPLANTED WITH THE SAME RESULT. TWO OF THE THREE SURGICAL CASES UTILIZED A COMPANY D CARTRIDGE FOR LENS LOADING AND A COMPANY C CARTRIDGE WAS UTILIZED FOR ONE CASE WITH THE SAME OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19681046 ↗
• MalfunctionJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, ALL THREE IOLS DISPLAYED A TEAR ON THE PERIPHERAL EDGE. THE PATIENT HAD TO HAVE TWO LENSES EXPLANTED IN AN INITIAL PROCEDURE, AS THE SURGEON WAS NOT HAPPY WITH THE INTEGRITY OF THE LENS AND EVEN THOUGH THE THIRD LENS ALSO SHOWED AN IMPERFECTION THE SURGEON FELT THAT IT WOULD NEGATIVELY IMPACT THE VISUAL OUTCOME FOR THE PATIENT SO DECIDED TO COMPLETE THE SURGICAL PROCEDURE. DIFFERENT INJECTORS WERE UTILIZED FOR ALL THREE LENSES BEING IMPLANTED WITH THE SAME RESULT. TWO OF THE THREE SURGICAL CASES UTILIZED A COMPANY D CARTRIDGE FOR LENS LOADING AND A COMPANY C CARTRIDGE WAS UTILIZED FOR ONE CASE WITH THE SAME OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19681045 ↗
• InjuryJul 5, 2024Adverse 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 POOR DISTANCE VISION. CLINICAL REASON FOR EXPLANT WAS MYOPIC OUTCOME. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 6 MONTHS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19679035 ↗
• InjuryJun 9, 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 MYOPIC OUTCOME AND IOL COMPLICATIONS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17098642 ↗
• InjuryMar 15, 2023Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MALPOSITIONED LENS . THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HYPEROPIA WITH ASTIGMATISM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16546341 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT SEE TO READ A BOOK OR ANYTHING SMALL. DIFFICULT TO SEEING STREET SIGNS. INTERMEDIATE DISTANCE IS PRETTY GOOD. FEELS THE LENSES WERE MIS-ADVERTISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16270146 ↗