Clareon™ CNA0T0 (REF CNA0T0.135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652393584), received between May 16, 2024 and Apr 28, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Device Difficult to Setup or Prepare; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT IN THE SURGEON¿S OPINION, THE INJECTOR CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013386 ↗
• MalfunctionApr 13, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON OPERATED ACCORDING TO STANDARD PRACTICE. AFTER PRESSING THE PLUNGER, THE GAS ACTIVATED NORMALLY. WHEN THE LENS ADVANCED TO THE GUARD, THE SURGEON CHECKED THE LENS PRIOR TO INJECTION AND OBSERVED THAT THE LENS WAS NOT IN COMPLETE CONDITION. WHEN PRESSING THE LENS ACCORDING TO THE PROCESS, THE OPTIC PORTION OF THE LENS WAS FOUND TO BE INCOMPLETE. THE PHYSICIAN IMPLANTED THE LENS INTO THE PATIENT¿S EYE, BUT THE HAPTIC APPEARED WAVY AND BENT. AFTER WAITING FOR THE LENS TO FULLY UNFOLD, THE HAPTIC DID NOT RETURN TO ITS NORMAL SHAPE. THE PHYSICIAN WAS CONCERNED THAT THIS MIGHT AFFECT THE CAPSULAR BAG, SO THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNIT AVAILABLE IN THE CLINIC¿S STOCK.

  Patient problems: Insufficient Information

  MAUDE report 24861117 ↗
• MalfunctionFeb 27, 2026Device Difficult to Setup or Prepare

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE HAPTIC DID NOT ADVANCE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469474 ↗
• MalfunctionSep 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED, HAPTIC GOT STUCK AND DID NOT COME OUT AS EXPECTED. SO, THE SURGEON ASKED TO OPEN A SECOND LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051791 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, THE PATIENT UNDERWENT SURGERY TO REPLACE THE LENS IN BOTH EYES. IMMEDIATELY AFTER THE OPERATION, THE PATIENT EXPERIENCED AN UNEXPECTED EFFECT APPEARED ON ONE EYE ALL KINDS OF GLARE. THESE ARE DIAGONAL GLARE FROM LAMPS, FROM REFLECTED LIGHT IN A MIRROR, FROM THE REFLECTION OF SUNLIGHT FROM SHINY SURFACES. THIS WAS USUALLY A COLOR SPECTRUM. SOMETIMES IT'S JUST WHITE LIGHT FROM THE LAMPS. AT NIGHT, ON THE STREET, WHERE THERE WAS LITTLE LIGHTING, JUST SAW DIAGONALS OF LIGHT AND IT WAS STRIPED, APPARENTLY, IT DEPENDS ON THE TILT OF THE HEADLIGHTS. EVEN SUNLIGHT CAN BE REFLECTED. WHEN IT WAS MORE ILLUMINATED, THE PATIENT SAW EVERYTHING, BUT WITH MULTIPLE RAYS OF LIGHT. PATIENT WENT TO THE CLINIC ON THE THIRD DAY AFTER THE OPERATION AND THEN A MONTH LATER, BUT THE SURGEON SAID IT WAS THE PATIENT INDIVIDUAL PERCEPTION. HOWEVER, ANOTHER DOCTOR AT THE POLYCLINIC, EVEN BEFORE THE PATIENT HAD TIME TO TELL SOMETHING, WAS SURPRISED AT THE EXAMINATION ABOUT SPARKLE OF LENS ESPECIALLY THE LEFT EYE. THE SECOND EYE ALSO SOMETIMES GAVE THIS EFFECT, BUT LESS OFTEN AND MORE SMOOTHED OUT AND THERE WAS NO DIAGONAL STRIPES. THERE WAS NO LIFE OR HEALTH THREAT, D

  Patient problems: Visual Disturbances

  MAUDE report 22665333 ↗
• MalfunctionJul 7, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TRAILING HAPTIC WAS FOLDED WRONG AND INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED DUE TO BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE EVENT OCCURRED DURING INJECTION, THE SURGERY WAS COMPLETED WITH ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 22413490 ↗
• MalfunctionMay 2, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PHYSICIAN NOTED THAT THE LENS WAS SCRATCHED WITH A LINE ALL THE WAY ACROSS. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949290 ↗
• MalfunctionSep 25, 2024Failure to Eject; Failure to Eject

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299328 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTED THAT THERE WAS A TEAR IN THE POSTERIOR CAPSULAR BAG AFTER INSERTING THE LENS. THEN LENS WAS CUT AND REMOVED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL COMPANY LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2.

  Patient problems: Capsular Bag Tear

  MAUDE report 20134572 ↗
• MalfunctionJun 26, 2024Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT IMPLANTED THERE WAS ISSUES WITH INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19614823 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED REFRACTIVE -7.00 D OUTCOME. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REFRACTIVE SURPRISE WAS -6.50 NOW MORE THAN 1 WEEK POST OP. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19329920 ↗