Clareon™ CCA0T0 (UDI 00380652397421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652397421), received between Jun 28, 2023 and Sep 24, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Product Quality Problem

  A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed defective. The lens was explanted during initial procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50882139 ↗
• MalfunctionMay 27, 2026Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DAMAGED, AND THE SURGEON SUBSEQUENTLY REMOVED AND EXCHANGED THE IOL FOR AN UNKNOWN REPLACEMENT LENS DURING THE INITIAL IMPLANTATION PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. IN THE SURGEON¿S OPINION, THE DAMAGED LENS CONTRIBUTED TO OR CAUSED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300549 ↗
• MalfunctionApr 17, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS ADVANCED TOO FAR AND EXITED TIP OF INJECTOR IN THIS OCCURRENCE THE IOL WENT TOO FAR FOR SOME REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24911093 ↗
• MalfunctionFeb 13, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC COMING OUT STRAIGHT WHEN THE IOL WAS BEING INSERTED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS PATIENT CONTACT WITH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24333247 ↗
• MalfunctionFeb 12, 2026Inaccurate Delivery

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CAME OUT BEFORE NEEDED. THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 24322338 ↗
• MalfunctionFeb 4, 2026Device Difficult to Setup or Prepare

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24258595 ↗
• MalfunctionDec 31, 2025Inaccurate Delivery; Inaccurate Delivery

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME OUT OF INCISION WAS NOT LARGE ENOUGH. NO INJURY TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932673 ↗
• MalfunctionOct 30, 2025Device Difficult to Setup or Prepare; Activation Failure; Device Difficult to Setup or Prepare; Activation Failure

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD DIFFICULTY ADVANCING DUE TO A FAULTY CO2 MECHANISM. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED, THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY, HOWEVER SHE NOTICED THAT THE COMPANY PRE-LOADED DELIVERY SYSTEM SEEMED TO RUN OUT OF CO2 TOWARDS THE END OF THE IMPLANTATION AND THE LENS WAS NOT PROPELLED FORWARD AS IT NORMALLY WAS.

  Patient problems: Insufficient Information

  MAUDE report 23424905 ↗
• MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE LEADING HAPTIC FOLD POSTERIOR TO THE OPTIC AFTER IMPLANTING THE LENS. IN THE SURGEON'S OPINION STATES THAT THE POSTERIOR FOLDED HAPTICS WITH DEVICE HAS BEEN A REOCCURRING ISSUE AND THE LENS REMAINS IMPLANTED. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961638 ↗
• MalfunctionJul 16, 2025Failure to Deliver; Failure to Deliver

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE IMPLANT WAS STUCK IN THE INJECTOR. UNSPECIFIED BACK-UP LENS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22519022 ↗
• MalfunctionJul 12, 2025Inaccurate Delivery; Activation Failure; Activation Problem; Inaccurate Delivery; Activation Failure; Activation Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TECH STOPPED PRESSING THE LEVER AND FOR UNKNOWN REASON AND THE LENS CONTINUED MOVE FORWARD, AND CO2 CONTINUED FLOW. ADDITIONAL INFORMATION REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22488701 ↗
• MalfunctionJul 4, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT ADVANCE/LOAD/INJECT AS EXPECTED. SURGEON STATED THAT THEY HAD USED THIS TYPE OF LENS MULTIPLE TIMES. PROCEDURE COMPLETED THE SAME DAY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22403627 ↗
• MalfunctionMar 24, 2025Failure to Fold; Failure to Deliver; Failure to Fold; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DUE TO IRREGULAR FOLDS MAKING THE IOL HARD TO DELIVER. THE PROCEDURE IS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT, IN THE SURGEON¿S OPINION IRREGULAR FOLDS MADE IT HARD TO DELIVER. LENS REMAINED IN THE DELIVERY SYSTEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682713 ↗
• MalfunctionMar 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD DEFECTIVE LENS. THE LENS WAS WASTED DUE TO LEAD HAPTIC FAULTY AND NOT IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21547104 ↗
• MalfunctionMar 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAD DEFECTIVE LENS. THE LENS WAS WASTED DUE TO LEAD HAPTIC FAULTY AND NOT IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21546860 ↗
• MalfunctionJan 3, 2025Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21069071 ↗
• MalfunctionOct 8, 2024Material Deformation; Failure to Eject; Material Deformation; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEND WAS NOTICED IN THE INSERTION TIP. THE LENS DID NOT DEPLOY AND WAS NOT INSERTED INTO THE PATIENT. A REPLACEMENT LENS WAS USED, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS OPENED, PLACED UNDER MICROSCOPE, AND READIED FOR INSERTION THEN NOTICED A BEND IN THE INSERTION TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394406 ↗
• MalfunctionApr 24, 2024Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, FAILED TO INJECT INTO EYE AS PER SURGEON WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED NO PATIENT HARM AND SURGEON'S PROGNOSIS WAS NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174878 ↗
• MalfunctionJul 5, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER WAS PINCHING THE OPTIC/TRAILING HAPTIC, THE MATERIAL WAS PINCHED. HENCE THE SURGERY WAS NOT COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17255303 ↗
• MalfunctionJun 28, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER WAS PINCHING THE OPTIC/TRAILING HAPTIC, THE MATERIAL WAS PINCHED. HENCE THE SURGERY WAS NOT COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17215904 ↗