Clareon™ CNA0T0 (REF CNA0T0.290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652396516), received between Jan 31, 2024 and Apr 3, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Inaccurate Delivery

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS CAUGHT IN THE INCISION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE SURGEON DID NOT REMEMBER THIS SIZE HAS A LARGER NOZZLE AND NEEDS A WIDER INCISIONS.

  Patient problems: Insufficient Information

  MAUDE report 24774738 ↗
• MalfunctionOct 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC FLIPPED AND WOULDN'T LET THE SURGEON STOP INJECTING. LENS WAS INJECTED HALFWAY BY THE SURGEON BEFORE REMOVAL. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23332085 ↗
• MalfunctionJul 14, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ADDITIONAL INFORMATION RECEIVED STATING TRAILING HAPTIC STUCK TO OPTIC. LENS WAS LEFT IMPLANTED. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22496130 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MISSED TARGET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT NINE DIOPTERS LESS POWER. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 20622798 ↗
• InjuryOct 30, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IMPLANTATION FAILURE OCCURRED THOUGH INCISION ENLARGEMENT HAS BEEN DONE. THE LENS WAS SUBSEQUENTLY LOADED IN NON-PRELOADED CARTRIDGE. WHEN THE IMPLANT WAS DEPLOYED IN THE EYE, HALF OF THE UPPER HAPTIC WAS BROKEN AND REMOVED. THE IMPLANT WAS POSITIONED NORMALLY, BUT IT WAS DECIDED TO LEAVE IT IN PLACE SO AS NOT TO BE DELETERIOUS IF THE IMPLANT WAS REMOVED AS THE LENS DIOPTER WAS HIGH. ADDITIONAL INFORMATION WAS RECEIVED STATING AS PER THE PATIENT'S DIOPTER AND EYE TYPE (SMALL WITH CORNEAL DEGENERATION), SURGEON DECIDED TO LEAVE IT IN, AS LENS WAS STABLE. ON POST-OP DAY 7, THE IMPLANT WAS CENTERED.

  Patient problems: Eye Injury

  MAUDE report 20570641 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS EXPLANATION AND REPLACEMENT SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. THE SURGEON REPORTED THAT, THE POST OPERATIVE SWELLING CONTRIBUTED TO THE BLURRY VISION AND THE BLURRY VISION WILL SUBSIDE OR RESOLVE ONCE THE SWELLING IS HEALED.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 18612061 ↗