Clareon CNWTT0 (UDI 00380652408042)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652408042), received between Jan 4, 2023 and Oct 24, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT UPON UNFURLING, THE LENS APPEARED TO HAVE SCRATCH. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376529 ↗
• InjuryAug 21, 2025Adverse 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, PATIENT EXPERIENCED BLURRY VISION AND SIGNIFICANT HYPEROPIC OUTCOME. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS EXPLANTED WITH REASON BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH ATIOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22858463 ↗
• InjuryAug 4, 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 POOR VISION WITH COMPANY LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNKNOWN MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR OPTICAL OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22698095 ↗
• InjuryMay 20, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED HALOS, GLARE, RINGS AND. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE SEVERE DYSPHOTOPSIA. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22054256 ↗
• MalfunctionJul 18, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SCRATCHES ON THE POSTERIOR SIDE OF THE LENS WAS OBSERVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO ISSUE WITH THE IOL AS WELL AS THE DELIVERY SYSTEM. NO FURTHER REPORTS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE OPERATION WAS COMPLETED, THERE WAS NO REASON FOR EXPLANTATION - MINIMUM OPTIC DAMAGE COMPARABLE TO A DEFECT AFTER NDYAG, MOREOVER FAR ENOUGH FROM THE OPTICAL AXIS NOT TO INTERFERE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770380 ↗
• MalfunctionJul 18, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SCRATCHES ON THE POSTERIOR SIDE OF THE LENS WAS OBSERVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO ISSUE WITH THE IOL AS WELL AS THE DELIVERY SYSTEM. NO FURTHER REPORTS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE OPERATION WAS COMPLETED, THERE WAS NO REASON FOR EXPLANTATION - MINIMUM OPTIC DAMAGE COMPARABLE TO A DEFECT AFTER NDYAG, MOREOVER FAR ENOUGH FROM THE OPTICAL AXIS NOT TO INTERFERE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19769594 ↗
• MalfunctionJan 4, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), SCRATCH IN THE IOL OPTIC WAS NOTED. THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE AND A BACKUP LENS WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16093156 ↗