Clareon™ CCA0T0 (UDI 00380652397292)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
- 17
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652397292), received between Dec 2, 2022 and Sep 22, 2026 — classified as 1 injury, 16 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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
- Material Twisted/Bent4
- Device Difficult to Setup or Prepare3
- Break2
- Defective Device2
- Failure to Advance2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Failure to Deliver1
Patient problems
- Insufficient Information11
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Deformation
A physician reported that subsurface nano glistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested, received and stated there has been no visual impact to patient at all.There are multiple medical reports associated with same event. This file is 27 of 29
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857582 ↗MalfunctionMar 12, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC WAS TWISTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Insufficient Information
MAUDE report 24578993 ↗MalfunctionFeb 13, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE PLUNGER WENT PAST THE LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24332583 ↗MalfunctionFeb 12, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24320691 ↗MalfunctionJan 30, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC CAME OUT STRAIGHT OR BENT. PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 3 FILES.
Patient problems: Insufficient Information
MAUDE report 24219653 ↗MalfunctionJan 27, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PLUNGER WENT PASSED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24186628 ↗MalfunctionJan 7, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE FRONT HAPTIC AND THE LENS POSITIONED IN THE BAG WERE FINE. HOWEVER, THE TRAILING HAPTIC HAD STRAIGHTENED AND BECAME STUCK IN THE CARRIAGE, WHILE THE PLUGGER HAD ALREADY BEEN DEPLOYED INTO THE BAG. ALTHOUGH THE LENS ITSELF WAS INTACT, THE SURGEON FACED DIFFICULTY INSERTING THE SECOND HAPTIC BECAUSE IT KEPT GETTING STUCK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23989194 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT HAD DISSATISFACTION. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA NOTES TEMPORAL BLUR, COULD NOT DESCRIBE AS EITHER BRIGHT OR DARK. THE PATIENT VISUAL FIELD, RETINAL IMAGING (OPTOS), AND OPTICAL PATH DIFFERENCE (OPD) WAS UNREMARKABLE. IT WAS AFFECTING HIS ADLS (ACTIVITIES AFFECTING HIS DAILY LIFE) AND, MAKING IT HARD TO FOCUS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH NON-COMPANY LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 23475498 ↗MalfunctionAug 11, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE (IOL), TIP OF THE PLUNGER PART WAS BROKEN OFF. THE ISSUE WAS NOTICED WHEN THE IOL WENT INTO THE EYE SUCCESSFULLY AND WAS LEFT IMPLANTED. THERE WAS NO IMPACT TO THE PATIENT.THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777912 ↗MalfunctionAug 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN OR TORN AND THE LEADING HAPTIC LOOKED DEFECTIVE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22773109 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BENT OR CRIMPED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738320 ↗MalfunctionJul 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR WAS MALFUNCTIONED. THE LENS WAS IMPLANTED MANUALLY BY FOLDED IT IN A COMPANY CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521090 ↗MalfunctionMar 20, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC FOLDS UNDERNEATH LENS. LENS WAS NOT DELIVERING AS INTENDED. THE IOL WAS IMPLANTED WITH NO ISSUE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651977 ↗MalfunctionJan 28, 2025Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRA OCULAR LENS (IOL) IMPLANTATION PART OF LOADER WAS CRUSHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21251618 ↗MalfunctionMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DID NOT LOAD CORRECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18825172 ↗MalfunctionJul 13, 2023Particulates; Particulates
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A LENS HAVING A SHEEN OR COATING ON IT THAT IS DIFFERENT FROM PREVIOUS LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17317636 ↗MalfunctionDec 2, 2022Defective Device; Defective Device
A NON HEALTH PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS MALFUNCTIONED AND WAS IMPLANTED PARTIALLY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH BACK UP LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WILL BE REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15903848 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
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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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