Clareon™ CNA0T0 (REF CNA0T0.145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652393607), received between Jan 3, 2022 and Mar 23, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 23, 2026Break; Failure to Prime

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY SUCCESSFULLY WITHOUT ANY HARM TO THE PATIENT AND IT WAS NOTICED DURING LOADING. IN THE SURGEON'S OPINION, THE HAPTIC HAD A LACERATION DUE TO NOT LOADING CORRECTLY. ACCORDING TO SURGEON THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664230 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC WAS CURLED UNDER THE LENS UPON INSERTION. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23803471 ↗
• InjurySep 16, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED THAT THE LEADING HAPTIC STUCK TO OPTIC. WHEN THE HAPTIC WAS DRAGGED ACROSS THE CAPSULE AND CREATED A TEAR IN THE CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NO FURTHER INFORMATION RECEIVED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS ABOUT THE STATEMENT HAPTIC STUCK TO OPTIC AND CREATED A TEAR IN THE CAPSULE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23061771 ↗
• MalfunctionAug 26, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A SURGEON REPORTED THAT DURING A CATARACT REMOVAL AND INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE POSTERIOR HAPTIC ELEMENT OF THE LENS WAS FOUND TO BE CUT DURING IMPLANTATION. THE LENS WAS EXPLANTED AND REPLACED WITH AN IDENTICAL LENS DURING THE INITIAL PROCEDURE, AND THE IMPLANTATION WAS UNEVENTFUL. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895794 ↗
• MalfunctionAug 11, 2025Inaccurate Delivery; Inaccurate Delivery

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS PARTIALLY STUCK IN INCISION, HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. IN THE SURGEONS OPINION PRODUCT WAS NOT CONTRIBUTED TO EVENT, CAUSE OF THE EVENT WAS LENS STUCK IN INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773462 ↗
• MalfunctionFeb 26, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NURSE REPORTED THAT DURING SURGERY, HAPTIC STICKING TO LENS. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE IN THE SURGEON OPINION, THE LENS LOADER CAUSED OR CONTRIBUTED TO THE EVENT AND THERE WAS A PATIENT CONTACT. SCHEDULED PROCEDURE COMPLETED THE SAME DAY AND THE LENS REMAINS IMPLANTED IN THE PATIENT EYE. NO PATIENT IMPACT WAS REPORTED. NO COMPLAINTS REPORTED FROM THE PATIENT AT 2- AND 6-DAYS POST OPERATION AT FOLLOWUP AND NEXT LEFT EYE (OS) INTRAOCULAR LENS (IOL) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468371 ↗
• MalfunctionDec 27, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR WENT BEYOND THE LENS, SUBSEQUENTLY LENS DID NOT EJECT FROM THE CARTRIDGE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025654 ↗
• MalfunctionJun 21, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS INJECTOR DID NOT WORK. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583189 ↗
• MalfunctionJun 3, 2024Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER WENT BELOW THE TRAILING HAPTICS, CAUSING IT TO BE STUCK WITH THE PLUNGER. ALTHOUGH LENS NOT ABLE TO BE DELIVERED SMOOTHLY, SURGEON MANAGED TO PUSH THE LENS IN WITH THE AID OF AN SECONDARY INSTRUMENT , PATIENT NOT AFFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448155 ↗
• MalfunctionDec 11, 2023Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS JAMMED IN THE PRELOADER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18302665 ↗
• InjuryMar 8, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE HAPTIC TORN OFF DURING IMPLANTATION AND RUPTURED THE POSTERIOR CAPSULE. THE LENS WAS EXCHANGED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. THE PATIENT WAS TESTED VISUAL ACUITY OF THE ORDER OF 0.7, THERE IS A SLIGHT SWELLING IN THE CORNEAL ZONE, IN THE PROJECTION OF THE MAIN ACCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rupture; Swelling/ Edema

  MAUDE report 13693292 ↗
• MalfunctionJan 3, 2022Scratched Material; Scratched Material

  A THEATRE MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO SCRATCHES ON THE LENS. THE ISSUE MUST HAVE OCCURRED WHEN THE LENS WAS FOLDING AND BEING IMPLANTED. SCRATCH MARKS WERE NOTICED THE WHEN THE LENS UNFOLDED IN THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13141207 ↗