Clareon CNW0T4 (UDI 00380652410212)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652410212), received between Dec 29, 2023 and Dec 12, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING AN CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGERY WAS PERFORMED ON (B)(6) 2025 AND WAS COMPLETED WITHOUT ANY ISSUES, BUT DURING THE MORNING ROUNDS ON (B)(6) 2025 A PROBLEM WAS OBSERVED WHERE THE OPTICAL SURFACE OF THE IOL APPEARED TO HAVE HAD A FILM OF OIL. UPON EXAMINATION, THERE WERE NO DIFFERENCES BETWEEN THE EYES AND VISION WAS GOOD, SO THERE DID NOT SEEM TO BE ANY ADVERSE HEALTH EFFECTS. THE SITUATION WAS BEING MONITORED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787172 ↗
• MalfunctionSep 19, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY A SCRATCHED IOL WAS NOTICED. THE LENS WAS IMPLANTED AND REMOVED DURING SAME PROCEDURE AND SURGERY COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093475 ↗
• MalfunctionAug 5, 2025Failure to Deliver; Failure to Deliver

  A PHYSICIAN REPRESENTATIVE REPORTED DURING UNKNOWN PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS NOT COME OUT FROM THE INJECTOR, AND INJECTOR MALFUNCTION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE.THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22715029 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. 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 209 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929504 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. 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 208 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928414 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. 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 153 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927851 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. 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 68 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926537 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR IMPLANTATION PROCEDURE (IOL),PATIENT HAD POSTOPERATIVE INFLAMMATION ,TWO OR THREE WEEKS AFTER THE POSTOPERATIVE INFLAMMATION HAD SUBSIDED. INFLAMMATION RECURRED, CELLS WERE FOUND AND DESCEMET'S MEMBRANE WRINKLED. CORTICOSTERIODS DROPS WAS INSTILLED FREQUENTLY AND FORTUNATELY THE SYMPTOMS HAVE SUBSIDED. THERE ARE 8 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 7 OF 8.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 18417419 ↗