Clareon™ CNA0T0 (REF CNA0T0.130)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652393577), received between Sep 21, 2021 and Feb 18, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Deliver1
- Material Split, Cut or Torn1
- Unintended Ejection1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE ADVANCEMENT OF THE IOL (INTRAOCULAR LENS) IT WAS NOTICED THAT THE PLUNGER WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24376382 ↗MalfunctionFeb 13, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24331174 ↗MalfunctionJun 2, 2025Failure to Deliver; Failure to Deliver
AN ACCOUNT MANAGER ON BEHALF OF THE FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WOULD NOT ADVANCE. THEY COULD NOT USE IT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22126162 ↗MalfunctionJun 19, 2024Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS STUCK IN INCISION, SUBSEQUENTLY REMOVED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567026 ↗MalfunctionMay 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS INSERTED INTO THE PATIENT'S EYE AND NOTICED A TEAR IN THE OPTIC. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237391 ↗InjurySep 21, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IOL IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE BROKEN. THE PATIENT WAS SUTURED AND NO LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED: THE PATIENT COULD NOT DELAY OR REMAIN WITHOUT IMPLANTATION, SO THE SURGERY WAS PERFORMED 4 DAYS LATER WITH A LENS OF THE SAME DIOPTER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12509606 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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