Clareon CNWTT0 (UDI 00380652408011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652408011), received between Jun 8, 2023 and Jan 23, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (6 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. How this data works · Data updated Oct 13, 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 23, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH GLARE. THE LENS WAS EXCHANGED OR EXPLANT WITH NONCOMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 24172930 ↗
• InjuryNov 28, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTOR WAS PUSHED THROUGH ON THE COMPANY CARTRIDGE, THE LENS HAPTIC WAS PINCHED AND DAMAGED. THE IOL GOT STUCK IN THE CARTRIDGE NOZZLE BEFORE BEING INSERTED INTO THE ANTERIOR CHAMBER OF THE EYE. DUE TO DAMAGE, THE LENS WAS NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED WITHOUT IOL IMPLANTATION. THE PATIENT REMAINED APHAKIC AND STAYED IN THE HOSPITAL FOR OBSERVATION AND IN A SUBSEQUENT PROCEDURE, IMPLANTATION OF THE UNSPECIFIED APPROPRIATE IOL WAS DONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23671211 ↗
• InjurySep 19, 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) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UNCORRECTED ASTIGMATISM AND EYE SWELLING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 23094519 ↗
• MalfunctionAug 6, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS SCRATCHED. THE LENS WAS REMOVED AND REPLACED WITH NEW LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725521 ↗
• InjuryMay 5, 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) IMPLANT PROCEDURE, PATIENT HAD MANY GLARES, HALOS, AND VISION NOT CRISP. THE LENS WAS EXCHANGED WITH NON-COMPANY LENS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT IS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21959137 ↗
• InjuryApr 30, 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 MANY GLARES, HALOS AND THE PATIENT'S VISION WAS NOT CRISP. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS OTHER MECHANICAL COMPLICATIONS OF LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21933185 ↗
• InjuryMar 28, 2025Adverse 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, PATIENT HAD INTOLERABLE DISPOROPSIS. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21719135 ↗
• MalfunctionOct 1, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS SCRATCHED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT BOTH ORIGINAL LENS AND BACK UP LENS WERE SCRATCHED AND BACK UP LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20343439 ↗
• InjurySep 19, 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, LENS WAS EXPLANTED IN SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED VISION NOT CLEAR, HAZE/FILM OVER VISION. CLINICAL REASON WAS REPORTED TO BE GENERALIZED DYSPHOTOPSIA. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY FOUR MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20256257 ↗
• InjurySep 6, 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 VISION WAS NOT BETTER. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS THE VISION NOT BETTER WITH VISUAL ACUITY, CHANGED TO IMPROVE VISION. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20157517 ↗
• MalfunctionJul 16, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS SCRATCHED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT BOTH ORIGINAL LENS AND BACK UP LENS WERE SCRATCHED AND BACK UP LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19751464 ↗
• MalfunctionJul 16, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS SCRATCHED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT BOTH ORIGINAL LENS AND BACK UP LENS WERE SCRATCHED AND BACK UP LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19751425 ↗
• MalfunctionJul 8, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19691312 ↗
• MalfunctionJun 10, 2024Scratched Material; Scratched Material

  HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCHES ON THE OPTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19498959 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT, AFTER THE LENS REPLACEMENT, THE PATIENT EXPERIENCED VISUAL DISTURBANCE DAILY IN THE FORM OF FLASHING OR STROBING. THEREFORE THE PATIENT EXPERIENCED HEADACHE AND ANXIETY. THE PATIENT WAS HAVING THESE VISUAL DISTURBANCES REGULARLY WHICH IMPACTED THE QUALITY OF LIFE. HENCE THE WALKING HOURS OF THE PATIENT WAS MISERABLE. THE PATIENT IS NOW LOOKING FOR THE LENS REPLACEMENT ALTHOUGH IT MIGHT BE PAINFUL AND RISKY. ADDITIONAL INFORMATION RECEIVED STATING THAT, THE PATIENT WAS EXPERIENCING THE DISTURBANCE IN THE VISION EVERYDAY, GOING OUT WAS NOT COMFORTABLE. LIGHTING IN STORES, RESTAURANTS, DOCTOR'S OFFICES, HOMES AND MORE MOST ALL CAUSE THE FLASHING. OVERHEAD LIGHTING AND LIGHTING COMING FROM LAMPS AT A CERTAIN ANGLE GENERALLY GIVE THE GRIEF. THE PATIENT ALSO SEEM TO BE HAVING MORE BRIGHT FLASHES ON THE OUTSIDE OF THE EYE WHEN LIGHTS HIT AT CERTAIN ANGLE. SINCE THE QUALITY OF PATIENT IS AFFECTED, THE PATIENT IS PROCEEDING WITH LENS REPLACEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Anxiety; Flashers; Headache; Visual Disturbances

  MAUDE report 17086115 ↗