Clareon CCWET3 (UDI 00380652455268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652455268), received between May 30, 2023 and Jun 8, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Failure to Unfold or Unwrap; Scratched Material

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SCRATCHED AND WOULD NOT UNFOLD. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE NOTICED DURING LOADING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427236 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DISTORTED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances

  MAUDE report 25083453 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT AND CLINICAL REASON BEING MENTIONED AS DISSATISFIED WITH VISUAL OUTCOME. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23956509 ↗
• InjuryApr 2, 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 DISTANCE VISION WAS NOT CRISP. CLINICAL REASON BEING MENTIONED AS IOL POWER INCORRECTLY SELECTED. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21754032 ↗
• InjuryJan 22, 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, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTH AND 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MYOPIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21206320 ↗
• InjuryOct 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY REPORTED THAT THE LENS WAS EXPLANTED DUE TO THE REASON OF MISSED TARGET. ADDITIONAL INFORMATION HAS BEEN RECEIVE IT STATES THAT THERE IS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464243 ↗
• InjurySep 19, 2024Optical Decentration; Optical Decentration

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, DECREASED VISUAL ACUITY (VA). THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DECENTERED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20255133 ↗
• InjuryMay 3, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED BLURRY VISION.CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE SUBJECTIVE VISUAL DISTURBANCE. THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS APPROXIMATELY FIVE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19238921 ↗
• InjuryMar 18, 2024Adverse 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THE IOL WAS REPLACED WITH UNSPECIFIED LIGHT ADJUSTABLE LENS (LAL) APPROXIMATELY FOUR MONTHS AFTER INITIAL PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 18922286 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND THE CONSUMER STATED WHEN SHE LOOK AT THE SOURCE OF THE LIGHT THEN LOOK AWAY IT TENDS TO GO AWAY. IF SHE CLOSES THE LEFT EYE WHICH WAS HER DOMINANT EYE SHE DOES NOT NOTICE AS MUCH GLARE, SEEMED TO BE WORSE IN STORES WITH FLUORESCENT LIGHTING.

  Patient problems: Visual Disturbances

  MAUDE report 18605834 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT, AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTPSIAS. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17019288 ↗