Clareon™ CCA0T0 (UDI 00380652397407)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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652397407), received between Jun 6, 2023 and Sep 25, 2026 — classified as 1 injury, 7 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
- Break1
- Crack1
- Defective Device1
- Device Damaged by Another Device1
- Failure to Eject1
- Failure to Prime1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A facility Representative reported that during an intraocular lens (IOL) implantation procedure, trailing haptic folded wrong. There was no patient contact. The procedure was completed on the same day.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 50898913 ↗MalfunctionApr 18, 2025Break; Crack; Device Damaged by Another Device; Break; Crack; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR NOTICES THE LENS WAS CRACKED. THE HAPTICS WAS BROKEN OR TORN OR MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21864779 ↗MalfunctionMar 14, 2025Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DIDN¿T FOLD AS THE SURGEON WANTED. THE LENS WAS NOT USED. THERE WAS NO PATIENT CONTACT OR HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS CONTINUED TO ADVANCE EVEN WHEN SURGEON STOPPED PRE ADVANCING. THE HAPTIC WAS ADVANCED OUT THE INJECTOR AND WAS NOT INSERTED INTO EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604303 ↗MalfunctionJan 3, 2025Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEONS OPINION THE LENS DID NOT FOLD. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 21066950 ↗MalfunctionMar 14, 2024Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE LENS. THE LENS WAS EXPLANTED IN A INITIAL PROCEDURE. LENS WAS REPLACED WITH SAME MODEL COMPANY LENS. THERE WAS NO PATIENT HARM. THE WOUND WAS NOT ENLARGED AND NO SUTURE WAS NECESSARY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18902954 ↗MalfunctionMar 5, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL HAD MALFUNCTIONED . ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18837295 ↗MalfunctionAug 10, 2023Particulates; Particulates
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED POLYCHROMATIC SHEEN ON THE LENS. REPORTER DENIED TO PROVIDE FURTHER INFORMATION. THERE WERE 3 FILES ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Insufficient Information
MAUDE report 17497966 ↗InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE INJECTOR WAS INSERTED INTO THE CORNEA, THE DOCTOR NOTICED THAT THE CARTRIDGE WAS CRACKED IN THE MIDDLE, THE IMPLANTATION WAS CARRIED OUT WITHOUT FURTHER PROBLEMS, BUT THE DOCTOR NOTED THAT THE IMPLANTATION PROCESS WAS MORE DIFFICULT WHEN SCREWING IN AND THE PLUNGER PUSHED THE LENS IN A WAY DIFFERENT AND NOT AS SMOOTH AS IN A NORMAL TRANSPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17072473 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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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