Clareon CCWTT4 (UDI 00380652457910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457910), received between Dec 19, 2023 and Jul 16, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 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 EXPERIENCED BLURRED VISION, GLARE, HALOS AND LIGHT SENSITIVITY. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. PROCEDURE COMPLETED ON THE SUBSEQUENT DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION DEFECT OF IOL (RIGHT EYE) CAUSING DIMINISHED VISION AND GLARE. PATIENT CANNOT TOLERATE RESIDUAL ASTIGMATISM (TORIC OVERCORRECTION). THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS. SURGEONS PROGNOSIS STATES PATIENT VISION WAS CLEAR.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 22521088 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRY VISION AND WAS NOT ABLE O DRIVE AT NIGHT. THE LENS WAS EXCHANGED FOR ANOTHER LENS 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21662990 ↗
• InjuryAug 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, WAS UNHAPPY WITH VISION OR HALOS. CLINICAL REASON, WAS MENTIONED AS POOR QUALITY OF VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL. FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19989632 ↗
• InjuryJan 25, 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 EXPERIENCED UNCLEAR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNABLE TO TOLERATE PANOPTIX. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM AND THE SURGEON STATED THAT THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Blurred Vision

  MAUDE report 18579399 ↗
• MalfunctionDec 19, 2023Crack; Crack

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354646 ↗