Clareon™ CNA0T0 (REF CNA0T0.155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652393621), received between May 16, 2025 and Sep 22, 2026 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Deformation

  A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested and received by stating there was no visual impact to the patient.There are multiple medical reports associated with same event. This file is 23 of 29.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854382 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced blurry vision and bad at night driving. Clinical reason being mentioned as myopic result. The IOL was explanted.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50232439 ↗
• MalfunctionApr 3, 2026Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LOWER HAPTIC DID NOT ENGAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24774737 ↗
• MalfunctionApr 2, 2026Failure to Advance

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS NOT CAUGHT BY THE ADVANCING PLUNGER TO PROPEL IT FORWARD AND INSTEAD WAS GETTING CAUGHT UNDERNEATH. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 24764007 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH RESULTS. CLINICAL REASON FOR EXPLANT WAS NOT SEEING CLEARLY. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS 1 MONTH 12 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 24471679 ↗
• MalfunctionFeb 2, 2026Failure to Deliver

  A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS JAMMED IN THE AUTOMATED INJECTOR, SO THE DOCTOR REMOVED AND INSTALLED A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS PATIENT CONTACT AND NO PATIENT HARM. SYMPTOMS WERE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235006 ↗
• MalfunctionDec 10, 2025Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, LENS DID NOT FORWARD CORRECTLY FROM THE MECHANISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 23769982 ↗
• MalfunctionNov 28, 2025Failure to Advance; Failure to Advance

  THE PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE INJECTOR MOVED OUTSIDE THE LENS AND REMAINED IN THE CARTRIDGES WITHOUT FOLDING. IT GOT STUCK TO THE WALL OF THE APPLICATOR. THE SURGERY WAS COMPLETED USING THE ANOTHER LENS. THERE NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671736 ↗
• MalfunctionAug 8, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER FAILED TO ENGAGE THE LENS, THE CARTRIDGE WAS OPENED TO LOAD THE LENS, THE PROXIMAL LOOP WAS FOUND BROKEN. SURGERY WAS COMPLETED USING ANOTHER LENS OF THE SAME POWER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22749137 ↗
• MalfunctionMay 16, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF IMPLANTATION OF THE INTRAOCULAR LENS, A RESISTANCE IN THE EXIT OF THE SAME WAS FOUND WITH CONSEQUENT BREAKAGE OF THE LOOP, THEREFORE IT WAS DECIDED NOT TO IMPLANT IT. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL.

  Patient problems: Insufficient Information

  MAUDE report 22037556 ↗