Clareon CCW0T3 (UDI 00380652431897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652431897), received between Sep 14, 2023 and Apr 9, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IMPLANTED IOL KEPT MOVING AND WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A COMPANY LENS OF DIFFERENT MODEL AND HALF DIOPTER LESS POWER IN A SECONDARY PROCEDURE. THERE HAD BEEN A HAPTIC ISSUE, IT WAS TOO BENDY AND WOULD NOT HOLD ITS POSITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24832961 ↗
• MalfunctionFeb 2, 2026Failure to Deliver

  A REGISTERED NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS JAMMED IN THE CARTRIDGE. ONLY THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT. BASED ON NEW INFORMATION PROVIDED, THE LENS WAS JAMMED IN THE CARTRIDGE, IT DID NOT ADVANCE PROPERLY THROUGH THE CARTRIDGE/INJECTOR. THE ISSUE WAS NOTICED DURING INSERTION. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PROCEDURE WAS PERFORMED ON THE PATIENT¿S LEFT EYE, AND NO PATIENT HARM OCCURRED. THE SURGEON STATED THAT IT IS UNCLEAR WHICH PRODUCT CONTRIBUTED TO THE EVENT, AND THE CAUSE OF THE INCIDENT REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232787 ↗
• InjuryOct 24, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE EXPLANTED IOL WITH PATIENT REASON AND CLINICAL REASON IOL MALFUNCTION. THE IOL WAS EXCHANGED WITH COMPANY SAME MODEL LENS ONE DIOPTER LESS 2 MONTHS, 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23380766 ↗
• MalfunctionJul 1, 2025Scratched Material; Scratched Material

  A NON- HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22372955 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT SHE HAD UNCOMPLICATED INTRAOCULAR LENS (IOL) SURGERY IN (B)(6) 2023. SHE HAS SINCE HAD ISSUES WITH DYSPHOTOPSIA AND NOTHING HAD RESOLVED IT. HER DOCTOR HAD TRIED GLASSES, AND SHE HAS HAD TWO SECOND OPINIONS, AND NO ONE COULD RESOLVE HER DYSPHOTOPSIA WHICH SHE DESCRIBED AS GLARE. SHE DESCRIBED IT AS A DEBILITATING GLARE. SINCE SURGERY SHE WAS NOT ABLE TO OBTAIN CONSISTENT REFRACTION. SHE HAD BLINDING AND SOMETIMES PAINFUL GLARE BOTH DAY AND NIGHT. SHE HAD HALOS BOTH INSIDE AND OUTSIDE. SHE HAD VISITED CORNEAL SPECIALISTS AND RETINA SPECIALIST WITH NO FINDINGS ON EXAM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20426122 ↗
• MalfunctionSep 19, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON INJECTED IOL AND NOTICED A SCRATCH ON OPTIC SO QUICKLY REMOVED IOL BEFORE IT FINISHED UNFOLDING. THE PROCEDURE WAS COMPLETED ON SAME DAY. THE PATIENT HARM WAS NOT INDICATED. SURGEON INDICATED THAT THE ISSUE MIGHT HAVE BEEN USER-RELATED (SCRUB TECHNICIAN NOT LOADING IOL CORRECTLY). SURGEON WAS UNSURE, HOW LONG WAS THE LENS WAS IN THE CARTRIDGE BEFORE IMPLANTING. TECHNICIAN SAID TO THE SURGEON THAT THE SCRUB LOADS THE LENSES ONCE THE DOCTOR SWITCHES TO CORTICAL CLEANUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20256100 ↗
• MalfunctionJun 20, 2024Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19573405 ↗
• InjurySep 14, 2023Failure to Align; Failure to Align

  A MATERIALS MANAGER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD DISTORTED AND BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DECENTERED IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17743933 ↗