Clareon™ CCA0T0 (UDI 00380652397285)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
Quick summary
This Alcon Clareon intraocular lens is an artificial lens implanted in the eye with a preloaded injector. The 24 reports describe problems with the injector during implant surgery, such as the lens coming out flipped, bent or crooked and small support arms breaking, with no deaths or injuries mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652397285), received between Apr 28, 2023 and Sep 26, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (6 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 Deformation6
- Device Difficult to Setup or Prepare4
- Material Twisted/Bent4
- Break2
- Defective Device2
- Failure to Advance2
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information13
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906820 ↗MalfunctionSep 23, 2026Material Deformation
A physician reported that subsurface nanoglistenings (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 6 of 29.
Patient problems: Insufficient Information
MAUDE report 50867613 ↗MalfunctionJul 30, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50080201 ↗MalfunctionJun 5, 2026Device Dislodged or Dislocated
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE FLIPPED WHEN INSERTED.
Patient problems: Insufficient Information
MAUDE report 25409471 ↗MalfunctionJun 4, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER BENT/ SLIDES OVER LENS. THE PROCEDURE COMPLETED THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 25403067 ↗MalfunctionApr 10, 2026Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY LENS WAS MISFIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE HAPTIC BROKE INTO THE INJECTOR. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843836 ↗MalfunctionApr 6, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24790255 ↗MalfunctionMar 18, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEVICE WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24624837 ↗MalfunctionFeb 5, 2026Defective Device
ADDITIONAL INFORMATION RECEIVED AND STATED THAT REPORTER NOTICED, LENS WAS CROOKED UPON PRIMING AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24268513 ↗MalfunctionFeb 2, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED THAT THE TIP OF THE DEVICE WAS CROOKED. THEY WERE UNABLE TO USE THE DEVICE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO PATIENT INJURY. BASED ON THE NEW INFORMATION RECEIVED ON 07-JAN-2026: THREE ADDITIONAL DEVICES OF THE SAME MODEL AND DIOPTER VALUE HAD THE SAME CROOKED-TIP ISSUE AND WERE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232564 ↗MalfunctionFeb 2, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED THAT THE TIP OF THE DEVICE WAS CROOKED. THEY WERE UNABLE TO USE THE DEVICE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO PATIENT INJURY. BASED ON THE NEW INFORMATION RECEIVED ON 07-JAN-2026: THREE ADDITIONAL DEVICES OF THE SAME MODEL AND DIOPTER VALUE HAD THE SAME CROOKED-TIP ISSUE AND WERE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232453 ↗MalfunctionFeb 2, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED THAT THE TIP OF THE DEVICE WAS CROOKED. THEY WERE UNABLE TO USE THE DEVICE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO PATIENT INJURY. BASED ON THE NEW INFORMATION RECEIVED ON 07-JAN-2026: THREE ADDITIONAL DEVICES OF THE SAME MODEL AND DIOPTER VALUE HAD THE SAME CROOKED-TIP ISSUE AND WERE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232419 ↗MalfunctionJan 28, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED THAT THE TIP OF THE DEVICE WAS CROOKED. THEY WERE UNABLE TO USE THE DEVICE. THE SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO PATIENT INJURY. BASED ON THE NEW INFORMATION RECEIVED ON 07-JAN-2026: THREE ADDITIONAL DEVICES OF THE SAME MODEL AND DIOPTER VALUE HAD THE SAME CROOKED-TIP ISSUE AND WERE UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197241 ↗MalfunctionJan 22, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE FRONT HAPTIC WAS TWISTED. IT WAS PARTIALLY IMPLANTED INTO EYE AND REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24148157 ↗MalfunctionDec 16, 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 PRELOADED LENSES DID NOT WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23815952 ↗MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT A LENS WAS UNABLE TO BE USED DUE TO BENT HAPTIC. THE ISSUE OCCURRED DURING LOADING WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580105 ↗MalfunctionOct 15, 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, NOTICED THAT THE THAT LEADING HAPTIC WAS ALREADY OUT. THERE WAS NO PATIENT CONTACT AND THE SURGERY PERFORMED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23276417 ↗MalfunctionSep 2, 2025Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER WENT OVER TOP OF LENS AND DID NOT ADVANCE IT. A NEW LENS WAS PULLED TO COMPLETE THE CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22932504 ↗MalfunctionAug 21, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, UPON ADVANCING THE LEADING HAPTIC FLIPPED IN THE CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT. DURING LOADING, THE LEADING HAPTIC KINKED AND FLIPPED LENS IN THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860958 ↗MalfunctionFeb 24, 2025Failure to Prime; Defective Device; Failure to Prime; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE WHILE ADVANCING THE LENS FOUND THE LENS WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. THE SURGERY COMPLETED WITH REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444274 ↗MalfunctionFeb 12, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED HAPTIC BROKEN OR TORN OR MISSING, AND ALSO STATED THAT THE PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21364753 ↗MalfunctionFeb 10, 2025Inaccurate Delivery; Inaccurate Delivery
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EJECTED BEFORE INTERESTING. THE PRODUCT WAS NOT AVAILABLE FOR SERVICE. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343192 ↗MalfunctionDec 12, 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 1 OF 4.
Patient problems: Insufficient Information
MAUDE report 20912221 ↗MalfunctionNov 14, 2024Material Discolored; Material Discolored
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE DOCTOR USING THE AUTONOME LENS NOTICED 3 INTRAOCULAR LENS (IOL) DISTORTIONS LINES ACROSS THE IOL. THIS LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AN OBSERVATION OF THE SURGEON AS HE WAS SWITCHING OVER TO AUTONOME. HE WAS NOTICING DISTORTION OR REFLECTION ACROSS LENS AS HE WAS IN IRRIGATION AND ASPIRATION. THE SURGEON SAID HE DID NOT NOTICE THIS BEFORE STARTING TO USE AUTONOME. THE LENSES REMAINED IMPLANTED. NO PATIENT IMPACT. NO VISUAL ISSUES. ONLY NOTICED AS LENS WAS BEING PLACED IN EYE. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685303 ↗MalfunctionJul 9, 2024Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE DEVICE WAS BROKEN AND THUS NOT USED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19700150 ↗
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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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