Clareon CCWET3 (UDI 00380652455251)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652455251), received between Dec 9, 2022 and Jun 30, 2025 — classified as 7 injuries.

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

• InjuryJun 30, 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 NOT HAPPY WITH THE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNKNOWN MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22356903 ↗
• InjuryJan 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT'S EYE COULD NOT ADJUST TO THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS.

  Patient problems: Insufficient Information

  MAUDE report 18423086 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POOR DISTANCE VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17863868 ↗
• InjuryJul 5, 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 POOR NEAR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS OVER-PULSED, REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17254780 ↗
• InjuryMay 1, 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 EXPERIENCED BLURRY VISION LIKE BEING UNDERWATER. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT WAS UNABLE TO TOLERATE SO THE LENS WAS EXPLANTED WITH ANOTHER COMPANY LENS. THE PATIENT PROGNOSIS WAS GOOD AND THERE WAS NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16843041 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING A 18.5 DIOPTER TORIC LENS WAS EXCHANGED FOR A 19.5 DIOPTER TORIC LENS DUE TO BLURRY VISION AND HYPEROPIA. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16127969 ↗
• InjuryDec 9, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; 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. SIGNIFICANT IMAGE DIFFERENCE IN 2 EYES. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15950364 ↗