Clareon™ CCA0T0 (UDI 00380652397414)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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652397414), received between Apr 9, 2024 and Jul 3, 2026 — classified as 2 injuries, 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. 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
- Device Difficult to Setup or Prepare2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Defective Device1
- Device Damaged by Another Device1
- Failure to Deliver1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear2
- Insufficient Information2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25704845 ↗MalfunctionMay 28, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE INJECTOR MALFUNCTIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25313386 ↗MalfunctionMar 10, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING PROCEDURE, THE HAPTIC HAD FOLDED UNDER THE OPTIC, AND THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT CONTACT OCCURRED. 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 24558363 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AFTER THE IOL WAS PRESENTED TO THE FIELD, THE SURGEON DECIDED NOT TO PROCEED WITH IMPLANTATION DUE TO A CAPSULAR TEAR. A SULCUS LENS WAS USED INSTEAD.
Patient problems: Capsular Bag Tear
MAUDE report 24144020 ↗MalfunctionMay 30, 2025Defective Component; Failure to Deliver; Defective Component; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DISTAL NOZZLE ON INJECTOR WAS DEFECTIVE. THE LENS REMAINED IN THE DELIVERY SYSTEM. IN THE SURGEON'S OPINION THE EVENT OCCURRED DUE TO NOZZLE OF CARTRIDGE WAS DAMAGED. THERE WAS PATIENT CONTACT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114740 ↗InjuryMay 8, 2024Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A POSTERIOR CAPSULAR TEAR WAS NOTICED DURING PARTIAL INSERTION OF THE LENS. SUBSEQUENTLY, THE LENS WAS EXPLANTED AND REPLACED WITH A LENS FROM ANOTHER COMPANY DURING THE SAME PROCEDURE. THE PATIENT EXPERIENCED FULL RECOVERY WITH NO REPORTED HARM.
Patient problems: Capsular Bag Tear
MAUDE report 19268514 ↗MalfunctionApr 9, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070253 ↗
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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