Clareon™ CCA0T0 (UDI 00380652397278)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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652397278), received between Nov 20, 2023 and Apr 10, 2026 — classified as 10 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
- Failure to Advance2
- Break1
- Defective Device1
- Failure to Deliver1
- Failure to Eject1
- Failure to Fold1
- Material Twisted/Bent1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF PLUNGER OVERRODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24845318 ↗MalfunctionFeb 19, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT RELEASE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24388069 ↗MalfunctionFeb 19, 2026Failure to Fold
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE LENS DID NOT FOLD CORRECTLY, AND THE ISSUE OCCURRED DURING LOADING/PRIMING AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24387304 ↗MalfunctionDec 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT THE SURGEON DID NOT LIKE ORIENTATION OF LEADING HAPTIC. USED BACK UP LENS. THERE WAS NO PATIENT CONTACT OR HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903326 ↗MalfunctionDec 1, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23681048 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22749351 ↗MalfunctionJul 25, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS MISSING. LENS WAS OPENED AND NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609994 ↗MalfunctionFeb 18, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN TECHNICIAN WAS PREPARING THE LENS NOTICED HAPTIC WAS COMING OUT FIRST, IOL WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21399210 ↗MalfunctionDec 13, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18317083 ↗MalfunctionNov 20, 2023Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE LENS EJECTED FROM BACK OF LOADER LENS GOT STUCK IN INJECTOR. THERE WAS PATIENT CONTACT. THE PROCEDURE COMPLETED DURING THE INITIAL PROCEDURE WITH THE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18168512 ↗
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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