Clareon CCWET4 (UDI 00380652455688)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652455688), received between Jul 9, 2024 and Mar 18, 2026 — classified as 5 injuries, 3 malfunctions.

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

• MalfunctionMar 18, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AND LENS WAS IMPLANTED AND EXPLANTED SAME DAY WITH SAME MODEL COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629859 ↗
• InjuryDec 19, 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 LIKED TORIC FOLDABLE INTRAOCULAR LENS (TFIOL) EYE BETTER. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23850671 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY. THE LENS WAS EXPLANTED AND EXCHANGED WITH DIFFERENT LENS 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23085961 ↗
• MalfunctionJul 25, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED STATING THAT THERE WAS A POSSIBLE SCRATCH ON LENS. LENS WAS OPENED AND NOT USED, THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620816 ↗
• MalfunctionJul 22, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS REMOVED DURING INITIAL PROCEDURE DUE TO HAPTICS BROKE OFF WHILE INSIDE THE EYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22565677 ↗
• InjuryFeb 7, 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 WAS UNABLE TO SEE WELL. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR REFRACTIVE OUTCOME. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT'S VISION WAS NOT BALANCED AND HE WAS UNABLE TO TOLERATE THE LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21331999 ↗
• InjuryNov 4, 2024Adverse 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, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION AND DIPLOPIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PERSISTENT SUBOPTIMAL BCVA. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT AS PER SURGEON OPINION THE PRODUCT DID NOT CAUSE THE EVENT. THE SYMPTOMS WERE CONTINUING.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment

  MAUDE report 20599034 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SHE EXPERIENCED BLURRY VISION AND STATED THAT PHYSICIAN HAS DONE A REPOSITIONING SURGERY AND IT DID NOT IMPROVE THINGS. HE THEN REFERRED HER TO GET A 2ND OPINION WITH ANOTHER PHYSICIAN, WHO ALSO COULD NOT FIND OUT WHY HER VISION WAS BLURRY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19700674 ↗