Clareon™ CNA0T0 (REF CNA0T0.285)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652396509), received between Sep 16, 2025 and Sep 17, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare2
- Device Damaged by Another Device1
- Failure to Fold1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Device Difficult to Setup or Prepare
A non health professional reported that during an intraocular lens (IOL) implantation procedure the leading haptic was folded behind optic and the procedure completed on the same day. Additional information has been received stating that the tip of the preloaded device was not in contact with the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802428 ↗MalfunctionMar 12, 2026Device Difficult to Setup or Prepare
A PHARMACIST REPORTED WITH A DESCRIPTION OF UNRETRIEVABLE, PLACEMENT FAILURE SCRUB NURSE EXPLAINED INJECTOR HAS CAUSED THE ISSUE AND THERE WAS NO IMPACT TO THE PATIENT. 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 24581881 ↗MalfunctionFeb 3, 2026Failure to Fold
A NURSE REPORTED THAT THE LENS WAS FAULTY AND IT WAS NOT USED BECAUSE LENS WOULD NOT FOLD PROPERLY.
Patient problems: Insufficient Information
MAUDE report 24244667 ↗MalfunctionSep 17, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS (IOL) IMPLANTED INTO THE CAPSULAR BAG WAS FOUND TO BE MISSING THE POSTERIOR HAPTIC AND ITS ELEMENT WAS LYING SEPARATELY. SUBSEQUENTLY THE DAMAGED LENS WAS REMOVED AND REPLACED WITH ANOTHER IDENTICAL LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY COMPLICATIONS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23074790 ↗MalfunctionSep 16, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC STUCK BEHIND LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23061297 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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