Clareon™ CCA0T0 (UDI 00380652397438)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens with the AutonoMe™ Automated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652397438), received between Apr 16, 2024 and Jul 30, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Failure to Fold” (4 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
- Failure to Fold4
- Device Difficult to Setup or Prepare3
- Failure to Deliver3
- Failure to Eject3
- Defective Component1
- Defective Device1
- Device Damaged by Another Device1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information8
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Failure to Advance
Patient problems: Insufficient Information
MAUDE report 50086134 ↗MalfunctionApr 21, 2026Failure to Fold; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LOADING ISSUE. THE TIP OF THE PRELOAD DEVICE CAME INTO CONTACT WITH THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942859 ↗MalfunctionMar 30, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24729356 ↗MalfunctionMar 30, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24729274 ↗MalfunctionJan 19, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE AND WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24109003 ↗MalfunctionJan 5, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEVICE WOULD NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23956654 ↗MalfunctionDec 15, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE OR DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23801962 ↗MalfunctionAug 19, 2025Failure to Fold; Failure to Fold
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LOADING ERROR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22846719 ↗MalfunctionJul 25, 2025Inaccurate Delivery; Inaccurate Delivery
A NON HEALTHCARE PROFESSIONAL REPORTED STATING THAT THE LENS WAS EJECTED TOO EARLY. LENS WAS OPENED AND NOT USED, THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608947 ↗MalfunctionMar 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS EJECTED SOON. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573394 ↗MalfunctionJan 6, 2025Failure to Prime; Material Twisted/Bent; Failure to Prime; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC BENT AND DIFFICULTIES IN LENS LOADING. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078025 ↗MalfunctionSep 20, 2024Unintended Ejection; Unintended Ejection
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS STUCK IN THE INCISION. IT DID ENTER THE EYE PARTIALLY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266112 ↗MalfunctionAug 21, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS MISSHAPED, BUT THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015010 ↗MalfunctionJul 17, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF PRELOADED DEVICE NOT WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS DID NOT DEPLOY PROPERLY.
Patient problems: Insufficient Information
MAUDE report 19766653 ↗MalfunctionMay 6, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IMPLANT PROCEDURE, PRELOADED LENS WOULD NOT EJECT THE LENS AND HAPTIC WAS STUCK. THE PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SAME DAY WITH THE DIFFERENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19246703 ↗MalfunctionMay 2, 2024Failure to Fold; Failure to Eject; Failure to Fold; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FAILED EJECTION. LENS DID NOT FOLDED PROPERLY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19229604 ↗MalfunctionApr 16, 2024Failure to Fold; Defective Component; Failure to Fold; Defective Component
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT FOLDED PROPERLY AND FAILED TO EJECT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114549 ↗
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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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