Clareon™ CCA0T0 (UDI 00380652397391)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
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652397391), received between Jun 17, 2022 and May 11, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (3 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 Deliver3
- Failure to Unfold or Unwrap3
- Device Difficult to Setup or Prepare2
- Device Damaged by Another Device1
- Failure to Eject1
- Failure to Fold1
- Material Twisted/Bent1
- Particulates1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS DID NOT DEPLOY PROPERLY WASTING AND REPLACING LENS WITH ANOTHER OF THE SAME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25137415 ↗MalfunctionNov 3, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT THE HAPTIC WAS IN WRONG PLACE. THE ISSUE OCCURRED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23450616 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, A COUPLE OF PRE-LOADED LENSES CAME OUT WITH THE LEADING HAPTICS TWISTED BELOW THE OPTIC, ALMOST FLIPPING THE IOL IN CASES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22749694 ↗MalfunctionJul 1, 2025Failure to Fold; Failure to Fold
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF LENS LOADING ERROR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22372181 ↗MalfunctionMay 12, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING SURGERY THE IMPLANT FAILED TO FIRE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22002949 ↗MalfunctionApr 17, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS WOULD NOT ADVANCE FROM THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21857028 ↗MalfunctionApr 1, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE NOTICED THAT THE TRAILING HAPTIC PRESENT POSTERIORLY UPON INJECTION TODAY. HE WAS ABLE TO GET IT TO RELEASE. NO PATIENT IMPACT/HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21737355 ↗MalfunctionMar 19, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS STUCK TO THE POSTERIOR LENS SURFACE AND WAS DIFFICULT TO DISLODGE. IOL MANIPULATION WAS USED TO RELEASE THE HAPTIC. THE LENS REMAINED IMPLANTED. THIS CAUSED DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21642642 ↗MalfunctionMar 14, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS STICK TO LENS AND NOT RELEASE VERY EASILY. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605164 ↗MalfunctionDec 13, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FRONT HAPTIC WAS STUCK UNDERNEATH THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 3 OF 4.
Patient problems: Insufficient Information
MAUDE report 20922908 ↗MalfunctionNov 15, 2024Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRUSHED IN THE INSERTER. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH ANOTHER LENS OF SAME MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20695739 ↗MalfunctionJul 6, 2023Particulates; Particulates
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY INTRAOCULAR LENS HAD SHEEN OR COATING ON THEM THAT WAS DIFFERENT. THERE ARE SIX MEDICAL REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 6 OF 6. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17264997 ↗MalfunctionJan 9, 2023Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS STUCK IN INJECTOR. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THE PROCEDURE WAS COMPLETED DURING THE SAME PROCEDURE WITH A SAME MODEL BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16125707 ↗MalfunctionJun 17, 2022Unintended Ejection; Unintended Ejection
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DELIVERY SYSTEM DID NOT STOP AFTER THE SURGEON INITIALLY INJECTED THE IOL FORWARD. THE PLUNGER KEPT MOVING FORWARD WITH THE PLUNGER TIP HAVING NOT PRESSURE. THE LENS WAS STILL IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14734602 ↗
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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