Clareon CNW0T3 (UDI 00380652409704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652409704), received between Apr 2, 2024 and May 22, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PATIENT DISSATISFACTION WITH IOL.

  Patient problems: Blurred Vision

  MAUDE report 25255967 ↗
• MalfunctionMar 25, 2026Material Discolored

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS (IOL) LOOKED BLUE BY THE SLIT LAMP. IT WAS ALSO STATED THAT THERE WAS NO SUBJECTIVE SYMPTOMS AND VISUAL ACUITY AND NO REMOVAL OF LENS WAS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 24684513 ↗
• MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANTATION WAS STOPPED DUE TO STRANGE FELT DURING IMPLANTATION. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER UNSPECIFIED LENS.

  Patient problems: Insufficient Information

  MAUDE report 22666392 ↗
• MalfunctionJul 8, 2025Break; Scratched Material; Break; Scratched Material

  A PHYSICIAN REPORTED THAT, WHILE PREPARING THE LENS FOR IMPLANTATION, THE OPTIC OF THE LENS WAS SCRATCHED AND THE HAPTIC WAS BROKEN. HENCE ANOTHER LENS WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434243 ↗
• MalfunctionMar 20, 2025Product Quality Problem; Product Quality Problem

  NON-HEALTHCARE PROFESSIONAL DURING INTRAOCULAR (IOL) LENS IMPLANT PROCEDURE THAT THE IOL WAS DEFECTIVE AND IT WAS WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652400 ↗
• InjuryNov 28, 2024Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS IMPLANTED AND BEING ROTATED INTO POSITION, THE PERIPHERAL CAPSULE WAS NOTED TO TEAR OPEN ALONG THE OPTIC EDGE ANTERIORLY. THE LENS WAS REMOVED AND REPLACEMENT SULCUS LENS WAS IMPLANTED. THERE WAS NO PATIENT IMPACT AND SYMPTOMS HAS BEEN RESOLVED. THE SURGEON SAID THERE WAS NO DIFFICULTY NOTED WITH LOADING THE IOL OR INSERTION OF THE IOL AND IT MAY OCCURRED AT ANY POINT OF TIME.

  Patient problems: Capsular Bag Tear

  MAUDE report 20805765 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL (INTRA OCULAR LENS) WAS EXCHANGED FOR THE SAME LENS MODEL BUT THREE DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 20406849 ↗
• MalfunctionApr 2, 2024Failure to Advance; Failure to Advance

  A PHARMACIST REPORTED THAT DURING SURGERY, AN INTRAOCULAR LENS WAS STUCK IN THE CARTRIDGE DURING THE OPERATION. THE BACKUP IMPLANT WAS USED TO OVERCOME THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19020156 ↗