Clareon™ CCA0T0 (UDI 00380652397193)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652397193), received between Aug 26, 2022 and Apr 23, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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.

• MalfunctionApr 23, 2026Device Damaged by Another Device

  A NURSE REPORTED THAT DURING INTRAOCULAR IMPLANTATION SURGERY THE SURGEON NOTICED THE HAPTIC WAS BROKEN PRIOR TO INSERTING THE LENS. SCHEDULED PROCEDURE COMPLETED THE SAME DAY AND THERE WAS NO PATIENT CONTACT. IN THE SURGEON¿S OPINION, DELIVERY SYSTEM CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966470 ↗
• MalfunctionDec 4, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717459 ↗
• MalfunctionSep 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FRONT HAPTIC HAD KINKED OFF WHILE ATTEMPTING TO ADVANCE THE LENS. THE SURGEON HAD REQUESTED A NEW LENS. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S LENS. THERE HAD BEEN NO PATIENT CONTACT AND NO HARM TO THE PATIENT. THE WOUND HAD NOT BEEN ENLARGED, AND NO SUTURE HAD BEEN NEEDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039308 ↗
• MalfunctionAug 22, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER SLID PAST IOL PRIOR TO LENS INSERTION. THE NEW LENS GOT IMPLANTED AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT FAULTY LENS WHILE LOADING DEVICE WITH CONFIRMED NO CONTACT WITH PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874449 ↗
• MalfunctionJun 23, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS A SCRATCH ON LENS THAT WAS NOTICED AFTER IT WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED STATING THAT PROCEDURE WAS COMPLETED ON SAME DAY AND LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305949 ↗
• MalfunctionApr 2, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGED FROM THE AUTONOME AUTOLOADER. THIS LENS HAD NOT NEEDED TO BE EXPLANTED BECAUSE IT WAS NOT DAMAGED THE CENTER OPTIC, HOWEVER LENS NICKED OR DAMAGED ON THE PERIPHERY EDGE OF THE OPTIC. ADDITIONAL INFORMATION RECEIVED STATING THAT COMPANY DEVICE USED AS USUAL AND THE PERIPHERY EDGE OF THE LENS WAS DAMAGED. AS PER THE SURGEON, THE INSERTER DAMAGED THE LENS. THERE WAS NO PATIENT INJURY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755883 ↗
• MalfunctionNov 15, 2024Failure to Advance; Failure to Advance

  A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS GOT STUCK/CAUGHT IN INCISION DURING INSERTION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692579 ↗
• MalfunctionAug 26, 2022Defective Device; Defective Device

  A REPORT RECEIVED FROM THE HEALTH AUTHORITY THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FOUND TO BE DEFECTIVE. THE LENS WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15302820 ↗