Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0 (REF CNAET0.200)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652406307), received between Jan 8, 2025 and Jun 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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
- Material Discolored2
- Device Difficult to Setup or Prepare1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS HAPTIC WAS OBSERVED TO BE DEFORMED AND ASYMMETRIC. THE HAPTIC APPEARED ABNORMAL AND WEAK, AND THE SURGEON NOTED THAT IT DID NOT PROPERLY OCCUPY THE CAPSULAR BAG AS EXPECTED. SINCE IT WAS STUCK FOR A LONG TIME AND WAS NOT LOOKING NORMAL, THE LENS WAS CONSEQUENTLY REMOVED AND REPLACED WITH A THREE-PIECE LENS IN AN INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25429961 ↗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 39 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926230 ↗MalfunctionJan 8, 2025Material Discolored; Material Discolored
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT WAS EXPERIENCING POOR VISION, ALSO REPORTED THERE MIGHT BE POSSIBLE PATIENT HARM.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 21100841 ↗
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- 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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