Clareon CCWTT0 (UDI 00380652413473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652413473), received between Jun 13, 2023 and Sep 11, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Explosion” (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.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implant procedure, the patient had blurred vision. The IOL was exchanged for unspecified Advanced Technology Intraocular Lens. Clinical reason for explant was mentioned as other mechanical complications of IOL.Additional information has been requested, received and stated the IOL was exchanged for another model same diopter company lens. There was no further patient impact.

  Patient problems: Blurred Vision

  MAUDE report 50734482 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN AGE RELATED CATARACT AND INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY OF VISION, BLURRY VISION ALL THE RANGES WITH NO DISTANCE VISION, GLARE FROM LIGHT, HALOS AROUND BRIGHT LIGHT, RESIDUAL ASTIGMATISM, A LOT OF FLOATERS, KERATOCONJUNCTIVITIS SICCA/SOME DRYNESS, DECREASE CONTRAST SENSITIVITY AND PROGRESSIVE WORSENING OF VISION. SOME DRYNESS PRESCRIBED ARTIFICIAL TEARS (ATS) 4 TIMES DAILY. TROUBLE WITH DISTANCE VISION PRESCRIBED WITH GLASSES. FLOATERS WERE GREATLY STABLE. THE PATIENT HAD POSTERIOR CAPSULAR OPACIFICATION/SECONDARY CATARACT AND YTTRIUM ALUMINUM GARNET (YAG) WAS PLANNED. THE PATIENT WAS OK WITH READERS, BUT REPORTS QUALITY OF VISION WAS LIMITED. SURGEON DISCUSSED RISK OF IOL EXCHANGE. THE OLD LENS WAS FREED WITH VISCOELASTIC AND MOBILIZED INTO THE ANTERIOR CHAMBER. THE OLD LENS WAS CUT IN HALF AND REMOVED WITHOUT COMPLICATIONS. CAPSULAR BAG WAS EXTENDED AND ANOTHER MODEL SAME COMPANY LENS WITH DIFFERENT DIOPTER WAS INJECTED WITH NON-COMPANY CAPSULAR TENSION RING BECAUSE OF POOR DILATION 5 MONTHS 12 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN

  Patient problems: Blurred Vision; Dry Eye(s); Posterior Capsule Opacification; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 22353024 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS NO IMPROVEMENT IN DISTANCE AND NEAR VISION. PATIENT HAD PROBLEMS WHILE WORKING, WALKING AND READING. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS PATIENT UNHAPPY WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 21108736 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Explosion; Adverse Event Without Identified Device or Use Problem; Explosion

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS LENS NOT COMPATIBLE WITH THE PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20873468 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17117167 ↗