Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0 (REF CNAET0.210)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652406321), received between Jul 9, 2024 and Sep 14, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Failure to Unfold or Unwrap1
- Inaccurate Delivery1
Patient problems
- Blurred Vision1
- Insufficient Information1
- 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.
MalfunctionSep 14, 2026Failure to Unfold or Unwrap
A non-healthcare professional reported that, during intraocular lens implantation surgery, the trailing haptic was stuck posteriorly under the IOL. This occurred after the lens was injected into the eye. The same lens was used, as the surgeon managed to pry the haptic away. The patient was not harmed. The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754908 ↗MalfunctionAug 28, 2026Inaccurate Delivery
Patient problems: Insufficient Information
MAUDE report 50497673 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL ONE DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY AND IT WAS AN ERROR IN EXPECTED REFRACTIVE VALUE. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Visual Impairment
MAUDE report 20266120 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT PATIENT'S CONDITION HAS BEEN GOOD AFTER THE REPLACEMENT.
Patient problems: Blurred Vision
MAUDE report 19698919 ↗
Other Extended Depth Of Focus Intraocular Lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- 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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