Clareon™ CCA0T0 (UDI 00380652397230)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652397230), received between Oct 11, 2023 and Apr 10, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Failure to Fold2
- Defective Device1
- Device Damaged by Another Device1
- Device Difficult to Setup or Prepare1
- Device Dislodged or Dislocated1
- Failure to Deliver1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF PLUNGER OVERRODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24839641 ↗MalfunctionFeb 14, 2026Failure to Fold
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND REPORTED THAT THE LENS DIDN'T FOLD CORRECTLY DURING LOADING/PRIMING. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24340722 ↗MalfunctionFeb 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS OPENED BUT NOT USED, AS THE LEADING HAPTIC WAS IN A BAD ORIENTATION, WITH NO PATIENT CONTACT OR HARM. THE SURGEON DECIDED TO USE THE BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320685 ↗MalfunctionNov 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED/BROKEN IN THE DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23617429 ↗MalfunctionOct 24, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PLUNGER WENT OVER THE LENS AND DID NOT ADVANCE. THE LENS WAS NOT IMPLANTED DURING THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23383242 ↗MalfunctionJul 1, 2025Failure to Fold; Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS AN ISSUE WITH LENS LOADING.
Patient problems: Insufficient Information
MAUDE report 22374050 ↗MalfunctionSep 27, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES DID NOT UNFOLD CORRECTLY. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 4 FILES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20322970 ↗MalfunctionMay 10, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF DEFECTIVE AND REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19286626 ↗MalfunctionOct 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BURRED VISION AT ALL DISTANCES. ON POST OPERATIVE FOLLOW UP, THE PHYSICIAN SAID, THE PATIENT STILL HAS SOME CATARACT LEFT OVER IN HIS EYE. THE PATIENT ALSO WAS TOLD THAT THE LENS HAS SHIFTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 17912650 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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