Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0 (REF CNAET0.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652406345), received between Jun 18, 2024 and Feb 26, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Failure to Advance

  A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED THERE WAS A PLUNGER ISSUE, PERFORMED THE MANIPULATION OF THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE INJECTOR BROKEN AT THE MOMENT OF IMPLANT INSERTION. THE INJECTOR PLUNGER VEERED TO THE RIGHT FROM THE BEGINNING OF THE MOVEMENT. IT HAD TO BE REALIGNED MANUALLY USING A MICRO-MANIPULATION HOOK.

  Patient problems: Insufficient Information

  MAUDE report 24455603 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS IOL IMPLANTATION PROCEDURE. THE PATIENT VISION REMAINED POOR AFTER SURGERY. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATELY 3 WEEKS, 2 DAYS AFTER INITIAL IMPLANTATION AND AFTER THE REPLACEMENT OF UNSPECIFIED MONOFOCAL LENS, THE PATIENT VISION BECAME GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, FURTHER DETAILS HAVE NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 22306771 ↗
• MalfunctionJun 20, 2025Failure to Deliver; Failure to Deliver

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS NOT EJECTED. AT THE TIME OF IOL IMPLANTATION, LENS DID NOT COME OUT OF THE CARTRIDGE. THE INJECTOR WAS DISASSEMBLED MANUALLY AND THE IOL WAS IMPLANTED WITH AN EXTERNAL CARTRIDGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296044 ↗
• MalfunctionJan 2, 2025Material Discolored; Material Discolored

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON COULD SEE AN OIL LIKE FILM ON THE SURFACE OF IOLS. WHEN SURGEON TOUCHED THE IOL AFTER IMPLANTATION WITH A HOOK OR HYDRO NEEDLE, ONLY THE TOUCHED AREA SEEMS TO BE PEELED OFF. THE SURGEON COMMENTED THAT AS FOR THE IOL SURFACE, IT MAY LOOK LIKE AN INDENTATION MADE AT THE TIME OF IMPLANTATION AND MAY LOOK LIKE THE REFLECTION OF A CEILING LIGHT. THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 5 OF 7.

  Patient problems: Insufficient Information

  MAUDE report 21057382 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT REPORTED THAT THE IOL WAS REPLACED WITH A SINGLE FOCUS LENS DUE TO POOR VISION AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT COMPLAINED THAT THE VISION WAS NOT CLEAR, SO THE LENS WAS REPLACED WITH A MONOFOCAL LENS. AFTER THE REPLACEMENT, THE PATIENT'S VISION WAS CLEAR AND NO PROBLEMS WERE NOTED; THE SUSPECT MODEL LENS, EXTENDED RANGE OF VISION LENS MAY NOT HAVE SUITED THE PATIENT. AGE MAY HAVE BEEN A CONTRIBUTING FACTOR.

  Patient problems: Visual Impairment

  MAUDE report 19561035 ↗