Clareon™ CNA0T0 (REF CNA0T0.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652393614), received between Oct 25, 2021 and Jun 3, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Break; Failure to Fold

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC-OPTIC CONNECTION BROKE DUE TO IMPROPER FOLDING WITHIN THE DEVICE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM AND NO INTERVENTION REQUIRED. THE CURRENT PATIENT CONDITION WAS SYMPTOMS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374646 ↗
• MalfunctionApr 4, 2026Device Difficult to Setup or Prepare; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC AND IOL WAS STUCK, IOL WAS NOT MOVED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE SURGERY WAS COMPLETED WITH BACK UP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24785108 ↗
• MalfunctionMar 24, 2026Failure to Advance

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, LENS INTRODUCER FAILED ENGAGEMENT TO PATIENT¿S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24680167 ↗
• MalfunctionFeb 6, 2026Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED VIA MEDWATCH FORM STATING THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING THE LENS, THE LEG OF THE LENS WAS STUCK IN THE INJECTOR PEN. THE SURGEON HAD TO USE AN UNSPECIFIED INSTRUMENT TO PULL THE LENS ARM OUT OF THE PEN WHILE THE LENS WAS ALREADY IN THE PATIENT'S EYE. THE SURGEON HAD ALREADY PLACED THE LENS AND WAS ABLE TO REMOVE THE LEG FROM THE INJECTOR WITHOUT HARMING THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275428 ↗
• MalfunctionSep 18, 2025Failure to Fold; Failure to Fold

  A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT FOLD CORRECTLY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085968 ↗
• MalfunctionAug 6, 2025Defective Component; Inaccurate Delivery; Device Damaged by Another Device; Defective Component; Inaccurate Delivery; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LEVER WAS PRESSED DOWN ON THE PRELOADED DELIVERY SYSTEM, THE LENS KEPT ADVANCING FORWARD DESPITE FINGERS BEING LIFTED OFF. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22726232 ↗
• MalfunctionJun 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE DELIVERY SYSTEM FAULTY/FAILED/DID NOT ADVANCE/LOAD/INJECT AS EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22292854 ↗
• MalfunctionMay 8, 2025Failure to Advance; Failure to Advance

  AN ACCOUNT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE, PLUNGER OVERRIDE THE LENS AND WOULD NOT STOP EVEN AFTER COMING OFF THE LEVER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21983174 ↗
• InjuryMar 11, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN RIGHT EYE, THE CARTRIDGE WAS BENT/DEFORMED, AND THE INJECTOR HAD DAMAGED THE LENS. ISSUE WITH COMPLAINT PRODUCT WAS NOTICED UP ON INSERTION. THE LENS WAS EXPLANTED BY ENLARGEMENT OF INCISION AND WAS CLOSED WITH SUTURES DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT, DURING POST OPERATIVE CARE NO PATIENT INJURY WAS REPORTED. THE PATIENT ISSUES WERE RESOLVED AND AS PER THE SURGEON PROGNOSIS WAS FULL RECOVERY. IN SURGEON OPINION PRODUCT QUALITY ISSUE WAS A MALFUNCTION AND THAT CAUSED OR CONTRIBUTED TO EVENT AND MALFUNCTION WAS NOT A PATIENT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 21572072 ↗
• MalfunctionFeb 18, 2025Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE/LOAD/INJECT AS EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21392333 ↗
• MalfunctionJul 30, 2024Defective Device; Defective Device

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19858835 ↗
• MalfunctionMar 11, 2024Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PRODUCT WAS FOUND TO BE DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 18874625 ↗
• MalfunctionOct 25, 2021Failure to Eject; Failure to Eject

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS GOT STUCK IN THE NOSE OF INJECTOR. THERE WAS A CONTACT OF THE IMPLANTATION SYSTEM WITH THE PATIENT. THE LENS WAS REPLACED DURING THE INITIAL IMPLANT PROCEDURE AND THERE WAS A DELAY OF SURGERY FOR 5 MINUTES. HOWEVER, THE PATIENT DID NOT HAVE ANY COMPLICATIONS DURING THE CONTINUATION OF THE OPERATION AND THE POSTOPERATIVE PERIOD. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE REPORTER IS UNWILLING TO FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692489 ↗