Clareon CCWET3 (UDI 00380652455183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652455183), received between Jan 6, 2023 and Jan 2, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Use of Incorrect Control/Treatment Settings

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED BLURRED VISION DIFFICULTY FOCUSING WITH DOMINANT EYE THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE MISCALCULATION OF TORIC CORRECTION DUE TO PRE OP MEASUREMENTS. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY THREE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23943739 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND WAS NOT HAPPY WITH OUTCOME. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HYPEROPIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22780758 ↗
• InjuryApr 23, 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) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DIFFICULTY SEEING AT ALL DISTANCES, VISUAL DISCOMFORT. THE CLINICAL REASON WAS REPORTED TO BE VISUAL DISCOMFORT . THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Eye Irritation

  MAUDE report 21892781 ↗
• MalfunctionMar 20, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS INITIALLY IMPLANTED INTO PATIENT¿S EYE BUT A HAPTIC TORE OFF AND A CRACK WAS OBSERVED IN THE MIDDLE OF THE LENS. HENCE THE LENS WAS THEN CUT AND REMOVED FROM THE PATIENT¿S EYE AND REPLACED WITH ANOTHER IDENTICAL LENS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652602 ↗
• InjuryJun 20, 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 HAS EXPERIENCE GLARE AND HALOS DURING DAY WERE EVIDENT RIGHT AFTER SURGERY AND POOR NIGHT VISION WAS WORSE THAN BEFORE. THE PATIENT WOULD PURCHASE A PAIR OF NIGHT DRIVING GLASSES AND SEE IF THAT HELPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19575985 ↗
• InjuryJan 24, 2023Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FREQUENT BLURRED VISION AS THE LENS WAS ROTATED OFF AXIS FREQUENTLY. THE IOL REPOSITIONING SURGERY WAS INITIATED TO REPOSITION THE LENS. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16231957 ↗
• MalfunctionJan 6, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCHES. SURGEON HAD TO CUT OUT THOSE IOL AND REPLACED THEM WITH THE SAME MODEL & DIOPTER IOL WITH NO ISSUE. SURGEON ALSO STATED THAT, THEY HAVE A NEW SCRUB TECH AND THEY THOUGHT IT WAS USER ERROR AND A SCRATCH ON THE LENS (WHICH IT COULD HAVE BEEN A SCRATCH IN THOSE CASES FROM LENS LOADING ISSUES). THE PATIENT IS NOT HAVING ANY ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE FILE 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112282 ↗