Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0 (REF CNAET0.155)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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652406215), received between Apr 29, 2025 and May 26, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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. 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
- Material Discolored3
- Adverse Event Without Identified Device or Use Problem2
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Visual Disturbances2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOS AND GLARE. LENS WAS EXPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS REPLACED WITH A COMPANY LENS DURING A SECONDARY PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Visual Disturbances
MAUDE report 25273650 ↗InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOS AND GLARE. LENS WAS EXPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS REPLACED WITH A COMPANY LENS DURING A SECONDARY PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Visual Disturbances
MAUDE report 25272617 ↗MalfunctionMay 21, 2025Inaccurate Information; Inaccurate Information
A PHYSICIAN REPORTED THAT THE SERIAL NUMBER OF THE LENS WAS FOUND MISWRITTEN AFTER SURGERY. NO PROBLEM OCCURRED WITH THE IOL. THERE'S NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060306 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 87 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927885 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 29 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927040 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 67 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926299 ↗
Other Extended Depth Of Focus Intraocular Lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- 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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