Clareon™ CNA0T0 (REF CNA0T0.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652393645), received between Oct 26, 2021 and Sep 25, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Deformation

  A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received and stated that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 16 of 29.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894672 ↗
• MalfunctionMay 29, 2026Failure to Advance

  A NON HEALTHCARE PROFESSIONAL REPORTED AN ISSUE WITH THE PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PLUNGER ADVANCED OVER LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. SURGERY WAS COMPLETED WITH A SPARE LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333403 ↗
• MalfunctionMar 30, 2026Failure to Deliver

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

  Patient problems: Insufficient Information

  MAUDE report 24713007 ↗
• MalfunctionFeb 3, 2026Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS FOUND TO BE DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 24248431 ↗
• MalfunctionJan 9, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A PRODUCT THAT FAILED DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS CONTACT BETWEEN THE EYE AND THE DEVICE DURING CATARACT SURGERY. IT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED THE SAME DAY. THERE WAS NO DAMAGE AND THE PATIENT WAS REPORTED IMPROVING POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017366 ↗
• 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 22407005 ↗
• MalfunctionMay 30, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE AFTER IMPLANTATION THE SURGEON NOTICED A CUT IN THE CENTRAL REGION OF THE LENS AND LENS WAS BROKEN IN HALF. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114555 ↗
• MalfunctionJan 10, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AS THE LENS WAS OPENED AND UNUSED DUE TO PLUNGER CRUNCHED THE LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124877 ↗
• MalfunctionAug 2, 2024Failure to Advance; Failure to Advance

  A FACILITY REPRESENTATIVE REPORTED WHEN INJECTING THE CARTRIDGE WORKED NORMALLY, BUT THE LENS WAS STUCK, WITHOUT BEING INSIDE THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19891140 ↗
• MalfunctionJun 26, 2024Break; Break

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A BLUE PIECE OF THE INJECTOR BROKE OFF IN THE INJECTION CARTRIDGE. THE PIECE WAS REMOVED AND THE IMPLANT WAS INSERTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612984 ↗
• MalfunctionMar 26, 2024Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS APPEAR TO HAVE SMALL POT HOLES. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND A NEW UNSPECIFIED LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE SURGEON OBSERVED A PATCH ON THE LENS THAT HAD SMALL INDENTIONS. THE IOL WAS EXCHANGED FOR SAME MODEL COMPANY LENS DURING INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977368 ↗
• MalfunctionMar 5, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR WAS MALFUNCTIONED OR NOT INJECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18834690 ↗
• InjuryNov 24, 2023Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS POSITIONED LIKE A (SUPERMAN) STRAIGHT FORWARD LEADING HAPTIC, CAUSING THE CAPSULAR BAG TO RUPTURE. THE LENS WAS NOT EXPLANTED BUT THE PATIENT WILL SEE THE RETINOLOGIST FOR ADVICE AND FOLLOW-UP. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT EXPERIENCED MODERATE HYPERTONIA. THE ANTERIOR VITRECTOMY WAS DONE ON THE SAME DAY OF IMPLANT PROCEDURE AND POSTERIOR VITRECTOMY WAS DONE 8 DAYS LATER BECAUSE OF TRACTION ON TRACTION ON RETINA. THE VISUAL ACUITY WAS 2/10 AND EYE HAD INFLAMMATION. IN SURGEON OPINION IMMEDIATE TEARING OF THE SAC GIVEN THE FRAGILITY OF THE TISSUES AND THE HAPTIC CAME OUT TWISTED CAUSED THE CAPSULAR BAG RAPTURE.

  Patient problems: Blurred Vision; Capsular Bag Tear; Inflammation; Intraocular Pressure Increased; Retinal Detachment

  MAUDE report 18204262 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A 2-DEGREE REDUCTION IN CATARACT RECEPTOR. THE CLINICAL REASON FOR THIS CHANGE WAS THAT THE UNCORRECTED VISUAL ACUITY (UVA) MEASUREMENTS OF 20/100 WERE DEEMED INADEQUATE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AS SECONDARY TO DENSENESS OF THE CATARACT THAT WAS PRESENT BEFORE THE PATIENT'S CATARACT SURGERY. THE PATIENT'S UNCORRECTED VISUAL ACUITY (UVA) PRIOR TO THE SURGERY WAS MEASURED AT 20/100. HOWEVER, IT WAS NOTED THAT THE MEASUREMENTS TAKEN DURING THIS TIME WERE NOT ACCURATE.

  Patient problems: Cataract; Visual Impairment

  MAUDE report 17824831 ↗
• MalfunctionJun 29, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SATED THAT, THE ADVANCEMENT OF THE IOL STOPS AS SOON AS SURGEON RELEASE THE SPEED REGULATOR. THIS WAS NOT THE CASE. ALTHOUGH THE ADVANCEMENT WAS STOPPED, THE IOL CONTINUED TO BE TRANSPORTED IN THE INJECTOR AND THUS ARRIVED (UNCONTROLLED) IN THE EYE. THE SURGEON IS VERY EXPERIENCED AND RECOGNISED THE DANGER IN TIME,SO THERE WERE NO COMPLICATIONS. THE ADVANCE OF THE IOL COULD NOT BE CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225161 ↗
• MalfunctionJun 29, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SATED THAT, THE ADVANCEMENT OF THE IOL STOPS AS SOON AS SURGEON RELEASE THE SPEED REGULATOR. THIS WAS NOT THE CASE. ALTHOUGH THE ADVANCEMENT WAS STOPPED, THE IOL CONTINUED TO BE TRANSPORTED IN THE INJECTOR AND THUS ARRIVED (UNCONTROLLED) IN THE EYE. THE SURGEON IS VERY EXPERIENCED AND RECOGNIZED THE DANGER IN TIME, SO THERE WERE NO COMPLICATIONS. THE ADVANCE OF THE IOL COULD NOT BE CONTROLLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225158 ↗
• MalfunctionOct 29, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND BROKE IN INJECTOR. THE LENS WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12722248 ↗
• MalfunctionOct 26, 2021Failure to Eject; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK IN THE SYSTEM BY PLUNGER DURING IMPLANTATION. THERE WAS NO PATIENT HARM. THE REPORTER WAS UNWILLING TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697921 ↗