Clareon CNW0T4 (UDI 00380652410182)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652410182), received between Jan 23, 2024 and Apr 22, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEFECT WAS FOUND IN THE OPTICAL PART OF THE LENS, WHICH COULD AFFECT VISUAL ACUITY. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND AN UNSPECIFIED REPLACEMENT LENS WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24953335 ↗
• MalfunctionJul 1, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED A SMALL SCRATCH WAS FOUND ON A LENS OPTIC AND THERE WAS NO MEDICAL TREATMENT GIVEN TO THE PATIENT. LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22371491 ↗
• MalfunctionMay 7, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, DEFECTIVE INTRA OCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21977411 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY AFTER THE LENS WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 97 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928186 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY AFTER THE LENS WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 61 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928029 ↗
• MalfunctionNov 19, 2024Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20720554 ↗
• InjurySep 11, 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 EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS HYPEROPIC SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20189417 ↗
• InjuryMay 10, 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 EXPERIENCED NO IMPROVEMENT IN VISION. CLINICAL REASON EXPLANT IS OVERCORRECTION OF ASTIGMATISM. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 1 MONTHS 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.

  Patient problems: Visual Impairment

  MAUDE report 19286441 ↗
• InjuryApr 25, 2024Crack; Optical Decentration; Crack; Optical Decentration

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR OVERALL VISION. CLINICAL REASON FOR EXPLANT WAS IOL DECENTRATION DUE TO CRACKED HAPTIC. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS MODEL 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19180183 ↗
• MalfunctionJan 23, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS CRACKED AFTER IMPLANTING THE LENS. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18563451 ↗