Clareon CCW0T3 (UDI 00380652431811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652431811), received between Jun 8, 2023 and Jan 15, 2026 — classified as 7 injuries.

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.

• InjuryJan 15, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS WRONG POWER AND MISALIGNED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT EXPERIENCED POST-OPERATIVE MYOPIC REFRACTIVE SURPRISE AFTER IMPLANTING A COMPANY 19.0 IOL WHILE AIMING FOR A -0.25 TARGET.

  Patient problems: Blurred Vision

  MAUDE report 24079055 ↗
• InjurySep 9, 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) IMPLANTATION PROCEDURE, THE PATIENT WAS UNABLE TO SEE CLEARLY AND EXPERIENCED OCCASIONAL DIPLOPIA. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS DURING A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS IDENTIFIED AS A REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Diplopia/Double Vision; Visual Impairment

  MAUDE report 23005555 ↗
• InjuryMay 23, 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 WANTS MORE NEAR VISION. CLINICAL REASON BEING MENTIONED AS NEAR NOT ENOUGH FOR HER MILD ASTIGMATISM REMAINS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22075815 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH POSITIVE DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNKNOWN MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POSITIVE DYSPHOTOPSIA AND THERE WAS NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22051790 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT INABILITY TO SEE NEAR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DID NOT ACHIEVE GOAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19069449 ↗
• InjuryJan 9, 2024Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO LENS MAL POSITIONED .THE IOL WAS REPLACED WITH UNSPECIFIED LENS, ONE MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18474351 ↗
• InjuryJun 8, 2023Adverse 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 EXPERIENCED HYPEROPIC SURPRISE, "BLURRY". THE IOL WAS EXCHANGED FOR AN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WERE CUT OF EYE AND REMOVED WITH NEW IOL.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17087337 ↗