Clareon™ CCA0T0 (UDI 00380652397445)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652397445), received between May 2, 2024 and Jan 27, 2026 — classified as 6 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
- Device Difficult to Setup or Prepare1
- Failure to Eject1
- Failure to Fold1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- Insufficient Information6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC CAME OUT STRAIGHT OR BENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 4.
Patient problems: Insufficient Information
MAUDE report 24189731 ↗MalfunctionJan 9, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CAME OUT WITH HAPTIC OUT TO THE RIGHT WHEN IMPLANTING. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24017720 ↗MalfunctionMay 15, 2025Material Deformation; Material Deformation
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS DID NOT LOAD IN THE PATIENT'S EYE PROPERLY. THE TIP OF THE PRELOAD DEVICE WAS IN CONTACT WITH THE PATIENT, AND THE LENS DID NOT REMAIN IN THE DELIVERY SYSTEM. THE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AND REPLACED WITH THE SAME MODEL, SAME DIOPTER, AND SAME COMPANY LENS DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT ISSUE WAS RESOLVED WITHOUT ANY HARM TO THE PATIENT. IN THE SURGEON'S OPINION, IT IS NOT CLEAR WHAT CAUSED OR CONTRIBUTED TO THE LENS NOT LOADING IN THE EYE PROPERLY.
Patient problems: Insufficient Information
MAUDE report 22026034 ↗MalfunctionNov 15, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BLOCKED IN INJECTOR AND NOT IMPLANTED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20696120 ↗MalfunctionSep 6, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WOULD NOT COME OUT OF THE INSERTER. THERE WAS PATIENT CONTACT. THE SURGERY WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20157432 ↗MalfunctionMay 2, 2024Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FAILED EJECTION. LENS DID NOT FOLDED PROPERLY.
Patient problems: Insufficient Information
MAUDE report 19230421 ↗
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- 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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