Clareon™ CCA0T0 (UDI 00380652397254)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652397254), received between Dec 12, 2023 and Sep 24, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884530 ↗
• MalfunctionFeb 6, 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 24275492 ↗
• InjuryNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, ON (B)(6) 2025, THE PATIENT WAS FOUND TO HAVE A DISLOCATED INTRAOCULAR LENS (IOL) AND A RETINAL DETACHMENT DURING THE ONE-WEEK POST-OPERATIVE VISIT. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST. THE VISUAL ACUITY PROGNOSIS WAS DISCUSSED AS UNCLEAR. THE MACULA-OFF RETINAL DETACHMENT WAS SURGICALLY REPAIRED ON (B)(6) 2025. ON (B)(6) 2025, THE SURGEON NOTED PUPIL CAPTURE AND A DISLOCATED IOL. SURGICAL INTERVENTION WAS PLANNED FOR SYNECHIAE RELEASE AND IOL REPOSITIONING IF THE HAPTICS WERE IN THE BAG OR IF UNABLE TO POSITION COMPLETE LENS IN BAG, AN IOL EXCHANGE WAS SUGGESTED TO BE PERFORMED. THE LENS WAS EXPLANTED AND REPLACED WITH DIFFERENT MODEL AND DIOPTER COMPANY LENS IN A SECONDARY PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Retinal Detachment

  MAUDE report 23451403 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS OPENED HOWEVER DID NOT IMPLANT THE LENS DUE TO BENT HAPTICS. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, BENT HAPTICS MIGHT BE DUE TO USER ERROR. THE SAMPLE HAS BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750872 ↗
• MalfunctionJul 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LEADING HAPTIC HAD STUCK IN THE CARTRIDGE DURING LOADING AND REMAINED IN THE DELIVERY SYSTEM. THE CAUSE OF THE ISSUE IS UNKNOWN. THERE WAS NO PATIENT CONTACT, AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413647 ↗
• MalfunctionMay 27, 2025Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) HAPTIC FOUND TO BE BROKEN. IT WAS ALSO STATED THAT THE TIP WAS FOUND TO BE BROKEN AS TECH PREPARED THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087832 ↗
• MalfunctionMay 15, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LEADING HAPTIC WAS ADHERED TO THE POSTERIOR SIDE OF THE OPTIC. THE SURGEON WAS ABLE TO RELEASE THE HAPTIC FROM THE POSTERIOR ASPECT OF THE OPTIC AFTER USING ADDITIONAL INSTRUMENTS, WHICH ADDED EXTRA TIME TO THE PROCEDURE AND THE RISK OF WORKING ON THE POSTERIOR SIDE OF THE LENS AFTER IMPLANTATION. NO PATIENTS OUTCOMES WAS NEGATIVELY IMPACTED WITH THIS EVENT AND THERE WAS NO DEFECTS ON THE OPTIC THAT WOULD IMPACT ANY POST OPERATIVE VISUAL OUTCOME AND THE LENS REMAIN IMPLANTED IN THE PATIENT'S EYE. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026553 ↗
• MalfunctionDec 31, 2024Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) DISPENSES TWISTED DUE TO PLUNGER OVERRIDING THE LENS. THE PROCEDURE WAS COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047032 ↗
• MalfunctionNov 21, 2024Material Deformation; Failure to Eject; Material Deformation; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTED TIP OF DEVICE WAS BENT. LENS UNABLE TO BE SAFELY PLACED IN EYE WITH DEVICE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742902 ↗
• MalfunctionSep 27, 2024Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS WAS STUCK IN THE INJECTOR AND DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20320089 ↗
• MalfunctionSep 20, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS BEING IMPLANTED, THERE WAS A SCRATCH NOTICED ON THE IOL. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. SURGERY WAS PERFORMED ON LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265875 ↗
• MalfunctionApr 2, 2024Failure to Eject; Failure to Eject

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT COME OUT OF THE INJECTOR. THE PRODUCT WOULD NOT BE RETURNED AS IT WAS CONTAMINATED WITH BODY FLUIDS.

  Patient problems: Insufficient Information

  MAUDE report 19017735 ↗
• MalfunctionFeb 5, 2024Unintended Ejection; Unintended Ejection

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) CAME OUT UPSIDE DOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18638995 ↗
• MalfunctionDec 12, 2023Failure to Advance; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL FAILED TO ADVANCE IN THE CARTRIDGE.

  Patient problems: Insufficient Information

  MAUDE report 18309669 ↗