Clareon CCWTT0 (UDI 00380652413541)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652413541), received between Nov 19, 2022 and Jan 30, 2025 — classified as 11 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN LASIK PROCEDURE, THE PATIENT EXPERIENCED POOR VISION & GLARE. CLINICAL REASON FOR EXPLANT MALFUNCTION INTRA OCULAR LENS (IOL), MECHANICAL COMPLICATIONS. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) WITH DIFFERENT MODEL LENS 8 MONTHS 22 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21274389 ↗
• MalfunctionJan 3, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE SURGEON IMPLANTED THEN TOOK IT OUT DUE TO BENT HAPTIC. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS WAS IMPLANTED AND THEN REMOVED. A BACKUP LENS WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21066474 ↗
• MalfunctionJan 2, 2025Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTICED SCRATCHED OR CRACKED AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21054179 ↗
• InjuryNov 11, 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 EXPERIENCED BLUR AT DISTANCE AND NEAR WITH GLARE AND HALOS. CLINICAL REASON BEING MENTIONED AS GLARE/HALOES/DYSPHOTOPSIA/BLUR ASSOCIATED WITH EDOF IOL (EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN NON COMPANY MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20653755 ↗
• InjuryOct 23, 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 HAD PRISMS/GLARE COLORS OFF AND BLURRY. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS UNABLE TO ADJUST TO MULTIFOCAL (MF), POOR VISUAL ACUITY (VA), COLOR PERCEPTION ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 20514441 ↗
• 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 4 MONTHS 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20134806 ↗
• InjuryJul 3, 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 GLARE AND CANNOT DRIVE AT NIGHT. CLINICAL REASON WAS MENTIONED AS DYSPHOTOPSIA CONTRACT REDUCTION . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL TWO MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19664269 ↗
• InjuryJun 12, 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 EXPERIENCED ISSUES WHEN READING LETTERS BEING DISTORTED. PATIENT ALSO HAD YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT BUT THE PROBLEM STILL EXISTS ALSO WHEN READING TEXT THE CENTER AREA OF THE TEXT WAS INDECIPHERABLE AT TIMES WONDERED IF OTHER PATIENTS HAVE HAD THIS EXPERIENCE.. THE PATIENT HAD BEEN TESTED FOR OTHER EYE ISSUES THAT COULD POSSIBLY RELATE TO THIS AND ALL TESTS COME BACK AS NEGATIVE. ADDITIONAL INFORMATION WAS RECEIVED AND PATIENT EXPERIENCED VISION BEING DISTORTED, LETTERS UNCLEAR, WHEN READING WITH/WITHOUT READERS LETTER SHAPE CHANGES, YTTRIUM ALUMINUM GARNET (YAG) LASER DID NOT IMPROVE VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19517691 ↗
• InjuryMay 6, 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 EXPERIENCED ISSUES WHEN READING LETTERS BEING DISTORTED. PATIENT ALSO HAD YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT BUT THE PROBLEM STILL EXISTS ALSO WHEN READING TEXT THE CENTER AREA OF THE TEXT WAS INDECIPHERABLE AT TIMES WONDERED IF OTHER PATIENTS HAVE HAD THIS EXPERIENCE. THE PATIENT HAD BEEN TESTED FOR OTHER EYE ISSUES THAT COULD POSSIBLY RELATE TO THIS AND ALL TESTS COME BACK AS NEGATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19247225 ↗
• InjuryApr 16, 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 EXPERIENCED WITH FOGGY VISION, HARD SEEING AT ALL RANGES. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS 24 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS FAILURE TO ADAPT . ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PATIENT ISSUES WERE RESOLVED AFTER REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 19114605 ↗
• InjuryMar 28, 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, BLURRY/HAZY VISUAL ACUITY. THE CLINICAL REASON WAS REPORTED TO BE OTHER MECHANICAL COMPLICATION OF INTRAOCULAR LENS .THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY FOUR MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18996339 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE/HALOS AT NIGHT, DIFFICULTY READING IN LOW LIGHT AND IN GENERAL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE WITH NON COMPANY IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16155989 ↗
• InjuryNov 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE EXPLANT AS PATIENT WAS UNABLE TO SEE AND DISLOCATED LENS DUE TO CAPSULE INSTABILITY. REPLACED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15830891 ↗