Clareon CCWTT0 (UDI 00380652413480)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652413480), received between Oct 30, 2024 and Jan 4, 2025 — classified as 4 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 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, CANNOT READ WITH THESE LENSES, DISTANCE IS GREAT. SYMPTOMS WERE CONTINUING. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED PATIENT CAN READ (20/25) UP CLOSE WITHOUT CORRECTION WITH BOTH EYES OPEN HOLDING THE NEAR CARD AT THE PROPER DISTANCE, PATIENT CANNOT SEE UP CLOSE WELL, BUT OBJECTIVELY MEASURES ARE GOOD. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO IMPROVEMENT IN THE PATIENT'S READING VISION. THE DISTANCE VISION WAS VERY GOOD, AND THE PATIENT IS USING +2.50 READERS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21075052 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS MALADAPTATION. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 1 MONTH AND 4 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20696345 ↗
• InjuryNov 7, 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, THE PATIENT WAS TESTED WELL AT A DISTANCE AND NEAR ON VISION CHART AND PHYSICIAN DECIDED TO EXPLANT THE LENS. CLINICAL REASON BEING MENTIONED AS POOR QUALITY, WAXY IN NATURE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED IT STATES THAT COMPANY LENS WAS PLACED IN OS (LEFT EYE) 8 MONTHS PRIOR. PATIENT COMPLAINTS OF FOGGY VISION SINCE POM (POST OPERATIVE MONTH) I. REASSURANCE AND HANDHOLDING PROVIDED. LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) PERFORMED AT POM5 FOR RESIDUAL -0.50. POSTERIOR CAPSULE CLEAR OSI ELEVATED. PATIENT TESTED WELL AT DISTANCE AND NEAR ON VISION CHART BUT DESCRIBES THE VISION AS POOR QUALITY AND WAXY IN NATURE. LENS WAS EXPLANTED AND EXCHANGED FOR A DIFFERENT MODEL AND DIOPTER COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. PATIENT STATES IMPROVEMENT IN OS VISION.

  Patient problems: Visual Impairment

  MAUDE report 20634981 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD HYPOTONY AND DECREASE IN BEST-CORRECTED VISUAL ACUITY (BCVA). PATIENT HAD TO BE REFERRED TO RETINA. THE LENS WAS EXCHANGED WITH UNSPECIFIED LIGHT ADJUSTABLE INTRAOCULAR LENS (LAL) 7 MONTHS AND 28 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT COMPANY STENT WAS EXPLANTED ON (B)(6) 2024. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

  Patient problems: Blurred Vision; Intraocular Pressure Decreased

  MAUDE report 20565123 ↗