Clareon CCWET3 (UDI 00380652455244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652455244), received between Jun 2, 2023 and Sep 15, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A Non-Healthcare Professional reported that following the intraocular lens (IOL) implant procedure, the patient experienced blurred vision, photophobia, "like looking through a white sheet," loss of binocular vision, iris delamination, transillumination defects, phimosis, and fatigue. The reporter stated that the patient had been receiving treatment at a hospital for the past two years. According to records, the surgeon's calculations called for one company model; however, another model was reportedly received. The reporter stated that the patient was at higher risk for lens explantation due to iris-related issues. The reporter also stated that she did not believe the events were related to a lens issue and initially did not wish to report a complaint. She was informed that the information would be documented and that the lens would be investigated as part of due diligence.

  Patient problems: Capsular Contracture; Eye Injury; Insufficient Information

  MAUDE report 50771934 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ASTHENOPIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 29 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Irritation

  MAUDE report 23988115 ↗
• InjuryDec 8, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BENT HAPTIC WAS NOTED ON INITIAL IMPLANTATION. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, IOL WAS DISLOCATED DUE BENT HAPTIC. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740277 ↗
• InjuryNov 11, 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 (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED MECHANICAL COMPLICATION OF THE IOL. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 23520764 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 23311158 ↗
• InjuryFeb 15, 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 REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 18710987 ↗
• InjuryOct 30, 2023Adverse 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 HAD HALO. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS IOL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 18030488 ↗
• InjuryJun 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN OPHTHALMIC TECHNICIAN REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED CYLINDRICAL REFRACTION. THE LENS WAS AT 96 DEGREES AND WAS REPOSITIONED AFTER WHICH THE PATIENT EXPERIENCED BLURRY VISION AND DIPLOPIA. THEREFORE, THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT IS RESIDUAL ASTIGMATISM. AFTER THE EXCHANGE, THE PATIENT WAS VERY HAPPY.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 17049633 ↗