Clareon CCWTT3 (UDI 00380652457323)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652457323), received between Mar 19, 2024 and Aug 22, 2025 — classified as 6 injuries, 1 malfunction.

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.

• MalfunctionAug 22, 2025Failure to Deliver; Failure to Deliver

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, THE SURGEON COULDN'T INSERT LENS INTO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22873970 ↗
• InjuryJun 2, 2025Adverse 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE UNCORRECTED ASTIGMATISM, NEEDS HIGHER POWER TORIC LENS. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY FOUR MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22125507 ↗
• InjuryJan 21, 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 HAD THE MOST TROUBLE WITH DISTANCE AND NEAR VISION. NIGHT VISION TENDS TO BE WORSE. THE PATIENT EXPERIENCED SPASMS FOR THE PAST COUPLE OF WEEKS WHILE CONCENTRATING ON VISION. THE PATIENT IS USING CYCLOSPORINE TWICE A DAY AND USING PRESERVATIVE FREE ARTIFICIAL TEARS 1 TO 2 TIMES AN HOUR. THE PATIENT UNDERWENT A YAG LASER CAPSULOTOMY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 21197091 ↗
• InjurySep 4, 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 HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 6 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20133393 ↗
• InjuryJul 18, 2024Adverse 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 EXPERIENCED BLURRY VISION AND NEAR VISION WAS WORSE BEFORE THAN SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS WRONG POWER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19773572 ↗
• InjuryJul 18, 2024Material Opacification; Device Dislodged or Dislocated; Material Opacification; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT TWO DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 19773571 ↗
• InjuryMar 19, 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 AS GLARE/HALOS AND CLINICAL REASON FOR EXPLANT BEING MEASUREMENT ISSUE. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SYMPTOMS WERE RESOLVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18930520 ↗