Clareon™ CCA0T0 (UDI 00380652397247)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652397247), received between Mar 20, 2025 and Jun 26, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT USED BECAUSE IT WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25632843 ↗
• MalfunctionJan 30, 2026Material Twisted/Bent

  A FACILITY REPRESENTATIVE THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC CAME OUT STRAIGHT OR BENT. PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 24219623 ↗
• MalfunctionOct 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC OF THE LENS BECAME JAMMED IN THE PRELOADED INJECTOR. THE LENS MADE CONTACT WITH THE PATIENT, BUT NO SURGICAL INTERVENTION WAS REQUIRED OTHER THAN CUTTING THE LENS OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23400415 ↗
• MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TERMINAL BULB OF THE TRAILING HAPTIC BECAME EMBEDDED BETWEEN TWO LAYERS OF THE PLUNGER. THE INDIVIDUAL HAD TO USE TOOTHED FORCEPS AND APPLY SIGNIFICANT FORCE TO EXTRACT IT. INITIALLY, THEY CONSIDERED AMPUTATING THE END OF THE HAPTIC, AS THE REST OF THE IOL HAD ALREADY BEEN IMPLANTED. HOWEVER, AFTER FOUR STRONG ATTEMPTS, THE HAPTIC WAS SUCCESSFULLY RELEASED. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962537 ↗
• MalfunctionJul 25, 2025Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE FRONT HAPTIC FOLDED BACKWARD. THE LENS WAS OPENED BUT NOT USED, AND THERE WAS NO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607120 ↗
• MalfunctionJul 22, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC TORE AND BECAME STUCK IN THE CHAMBER OF THE INSERTER WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22562480 ↗
• MalfunctionJul 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PRODUCT FOUND TO BE DEFECTIVE. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22547697 ↗
• MalfunctionJul 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STICKY HAPTICS WERE OBSERVED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 3 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22519153 ↗
• MalfunctionJul 5, 2025Activation Problem; Activation Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS EJECTED FROM THE CARTRIDGE TOO QUICKLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22406999 ↗
• MalfunctionJun 13, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING INTRA OCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LEADING HAPTIC PRESENTED POSTERIOR TO OPTIC AFTER IMPLANTING INTO THE EYE. THEY WERE FREED WITH A UNSPECIFIED INSTRUMENT. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22203211 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT 80 YEARS PATIENT WITH VISUALLY SIGNIFICANT CATARACT WAS IMPLANTED WITH COMPANY LENS FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT ENDED UP WITH A MYOPIC SURPRISE ABOUT -2.25. THE PATIENT WAS ALLERGIC TO ANTIBIOTICS. ON (B)(6) 2025 THE SURGEON SUGGESTED ANTIBIOTIC, NSAIDS AND STEROID DROPS TO PATIENT AS TREATMENT. THE PATIENT USED THE DROPS DAILY THESE MADE HER EYES BURN. THE SURGEON TOLD TO STOP THE DROPS. SHE WAS SEEING MANY FLASHES IN HER VISION. THE VISION WAS BLURRY. IN SLIT LAMP EXAMINATION OBSERVED SOME SCARRING. SHE HAD VITREOUS DETACHMENT. THE PATIENT NOTICES COLORS WERE MORE VIBRANT. THE DISTANCES VA WAS NOT IMPROVED BUT CLOSE WAS BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Corneal Scar; Visual Disturbances; Visual Impairment; Vitreous Detachment

  MAUDE report 21753797 ↗
• MalfunctionMar 20, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS STUCK TO THE POSTERIOR LENS SURFACE AND WAS DIFFICULT TO DISLODGE. IOL MANIPULATION WAS USED TO RELEASE THE HAPTIC. THE LENS REMAINED IMPLANTED. THIS CAUSED DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21652862 ↗