Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0 (REF CNAET0.205)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON VIVITY AUTONOME · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652406314), received between May 9, 2024 and Feb 23, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Unfold or Unwrap1
- Inaccurate Information1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
ACCORDING TO ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24415172 ↗MalfunctionOct 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC COULD NOT BE FOLDED PROPERLY AND THE IOL IMPLANTATION FAILED. AN INJECTOR WAS ALSO DEFECTIVE. THE IOL WAS IMPLANTED IN THE PATIENT'S EYE AS IT WAS AND REMAINS IN PLACE. THE SURGERY WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 23358358 ↗MalfunctionFeb 10, 2025Inaccurate Information; Inaccurate Information
A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOUND THE SERIAL NUMBER WAS MISLABELED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE ERROR WAS, THE FRONT PART OF THE GS1 CODE WAS PRINTED INSTEAD OF THE SERIAL NUMBER.
Patient problems: Insufficient Information
MAUDE report 21347081 ↗InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD A REFRACTIVE DEVIATION OF 1.5 D. THE IOL WAS REPLACED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 19276990 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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