Clareon™ CCA0T0 (UDI 00380652397148)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652397148), received between Apr 5, 2023 and Sep 15, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Failure to Deliver1
- Failure to Eject1
- Material Deformation1
- Material Opacification1
- Scratched Material1
Patient problems
- Insufficient Information4
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Deliver
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, the lens failed to launch from the cartridge.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50770259 ↗InjuryDec 31, 2024Material Deformation; Scratched Material; Appropriate Device Problem Term/Code Not Available; Material Deformation; Scratched Material; Appropriate Device Problem Term/Code Not Available
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS AN ISSUE WITH THE IMPLANTED LENS. THE SURGEON HAS PLANNED TO EXPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE DAY AFTER THE SURGERY IT WAS NOTED THAT THE LENS HAD 15-20 GLISTENING/"SCUFF" MARKS THAT APPEARED TO BE ON THE FRONT SURFACE OF THE LENS DISTRIBUTED DIFFUSELY OVER THE SURFACE. THESE WERE NOT NOTED ON THE DAY OF SURGERY AND SEEMED TO APPEAR OVER NIGHT AND HAVE NOT RESOLVED. THE SURGEON WAS USING NON COMPANY VISCOELASTIC AS A TRIAL. THE SURGEON ALSO STATED THAT THE PATIENT HAD VISION COMPLAINTS THAT MAY OR MAY NOT BE AS A RESULT OF THE LENS. THE SURGEON SAID THE PATIENT PROGNOSIS WILL BE GOOD AND HE WAS UNCLEAR IF AN EXPLANT WAS NECESSARY AT THIS MOMENT.
Patient problems: Insufficient Information; Visual Impairment
MAUDE report 21047304 ↗MalfunctionNov 19, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION LENS WOULD NOT ADVANCE THROUGH WOUND. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 20723041 ↗MalfunctionApr 5, 2023Material Opacification; Material Opacification
A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE LENSES WITH OPACITY CREEPING ANTERIORLY BEYOND RHEXIS.
Patient problems: Insufficient Information
MAUDE report 16683823 ↗
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- 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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