Clareon™ CCA0T0 (UDI 00380652397308)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 implanted in the eye during cataract surgery. The 25 reports mostly describe the lens or its delivery system getting stuck, failing to advance or unfold, or ejecting before correct placement; some mention blurred or impaired vision. The reports include 3 injuries and no deaths. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652397308), received between May 31, 2022 and Sep 29, 2026 — classified as 3 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance6
- Failure to Deliver5
- Failure to Unfold or Unwrap5
- Adverse Event Without Identified Device or Use Problem3
- Material Twisted/Bent3
- Device Difficult to Setup or Prepare2
- Failure to Eject2
- Particulates2
Patient problems
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions8
- Blurred Vision2
- Capsular Bag Tear1
- Eye Injury1
- Visual Impairment1
- Zonular Dehiscence1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Deliver
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the lens was stuck in the injector. It was unknown if the originally scheduled surgery was completed. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933049 ↗MalfunctionJun 12, 2026Failure to Advance
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTION SYSTEM DOES NOT ADVANCE ALONG THE AXIS BUT SLIGHTLY DIAGONALLY. WHICH PREVENTS CORRECT POSITIONING OF THE IMPLANT. ONCE THE TRAJECTORY WAS SET, IT WAS NOT POSSIBLE TO CORRECT THE INJECTION AXIS. A SECOND IMPLANT WAS USED AND COMPLETED THE PROCEDURE ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25485481 ↗MalfunctionApr 9, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OVERRODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24831879 ↗MalfunctionApr 3, 2026Inaccurate Delivery
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, AT THE MOMENT THE IMPLANT IS INJECTED, IT EXITS THE CARTRIDGE BUT REMAINS AT THE WOUND EDGE, DESPITE A DIOPTER POWER OF LESS THAN 24 D.
Patient problems: Insufficient Information
MAUDE report 24776434 ↗MalfunctionMar 2, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT WORK AND MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, WHEN THE PHYSICIAN WAS TRYING TO INJECT THE LENS INTO THE EYE, THE LENS PREMATURELY EJECTED FROM THE PLUNGER BEFORE IT WAS PLACED IN THE EYE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24485104 ↗MalfunctionJan 8, 2026Failure to Unfold or Unwrap; Failure to Deliver; Failure to Advance; Material Twisted/Bent
BASED ON NEW INFORMATION RECEIVED ON 06-JAN-2026: THE ISSUE OCCURRED DURING IOL IMPLANTATION PROCEDURE. THERE WAS PATIENT CONTACT. THE REPORTER WAS UNSURE ABOUT THE SPECIFIC EVENT. IT WAS REPORTED THAT WHEN THE LENS WAS INJECTED, IT EITHER CAME OUT WITH A STRAIGHT HAPTIC OR THE HAPTIC WAS STUCK TO THE BACK OF THE LENS. THE LENS REMAINS IMPLANTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24003579 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CANNOT SEE WELL ENOUGH AND READ ANYTHING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23605238 ↗MalfunctionSep 19, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN DELIVERY SYSTEM/CARTRIDGE / LENS WOULD NOT ADVANCE/DEPLOY/EJECT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23100882 ↗MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE LEADING HAPTIC FOLD POSTERIOR TO THE OPTIC AFTER IMPLANTING THE LENS. IN THE SURGEON'S OPINION STATES THAT THE POSTERIOR FOLDED HAPTICS WITH DEVICE HAS BEEN A REOCCURRING ISSUE AND THE LENS REMAINS IMPLANTED. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961433 ↗MalfunctionAug 14, 2025Failure to Unfold or Unwrap; Failure to Deliver; Failure to Unfold or Unwrap; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS STUCK AND WOULD NOT UNFOLD. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803532 ↗MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589499 ↗MalfunctionMay 2, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS UNABLE TO FULLY OPEN. CLINICIAN HAD TO REMOVE IT AND USE A NEW ONE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21949516 ↗MalfunctionApr 17, 2025Material Twisted/Bent; Material Twisted/Bent
NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH A DESCRIPTION OF BENT HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21860238 ↗MalfunctionMar 26, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC ADHERED TO THE POSTERIOR SIDE OF THE OPTIC. THE SURGEON WAS ABLE TO RELEASE THE HAPTIC. THERE WAS NO DEFECTS ON THE OPTIC THAT WOULD IMPACT ANY POST OPERATIVE VISUAL OUTCOMES.
Patient problems: Insufficient Information
MAUDE report 21696693 ↗MalfunctionMar 14, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INSERT/PUSHER WENT TO SIDE OF LENS AND ONLY PARTIALLY EJECTED LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, DEVICE WAS IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT IMPACT REPORTED. ISSUE WAS RESOLVED AFTER USING THE ANOTHER LENS. THE SURGEON PROGNOSIS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606483 ↗MalfunctionAug 22, 2024Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) NOT ADVANCING PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20026369 ↗MalfunctionJun 7, 2024Failure to Unfold or Unwrap; Failure to Eject; Failure to Unfold or Unwrap; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC STUCK TO THE POSTERIOR SIDE OF THE IOL. THE LENS WAS IMPLANTED AND LEFT BUT DID NOT DELIVER IN THE PROPER WAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19482012 ↗MalfunctionMay 27, 2024Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF PLUNGER WENT OVER INTRAOCULAR LENS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19400415 ↗MalfunctionFeb 20, 2024Unintended Ejection; Unintended Ejection
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EJECTED PREMATURELY. HENCE IT WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18738323 ↗MalfunctionJul 28, 2023Particulates; Particulates
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE COATING/SHEEN ON LENS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17412430 ↗MalfunctionJul 10, 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 17287045 ↗InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS TEMPORAL ZONULAR DEHISCENCE DUE TO THE IOL MOVING POSTERIORLY AND COMPRESSING THE TEMPORAL ANTERIOR CAPSULAR FLAP PRIOR TO LENS REACHING THE CENTRAL ANTERIOR CAPSULAR OPENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED STATING THE THERE WAS A TEAR IN CAPSULE DUE TO THE EVENT. THE IMPLANTED IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND THE SURGERY WAS COMPLETED WITH A BACK UP LENS.
Patient problems: Capsular Bag Tear; Eye Injury; Zonular Dehiscence
MAUDE report 15313478 ↗InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT TOLERATING BEING SET FOR NEAR VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS GIVEN AS NEED TO TARGET FOR DISTANCE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14927283 ↗MalfunctionJun 30, 2022Failure to Eject; Failure to Eject
A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS DID NOT EXPEL FROM THE CARTRIDGE CORRECTLY AND WAS REMOVED FROM THE PATIENT'S EYE AND A NEW LENS WAS USED TO COMPLETE THE PROCEDURE. NO HARM DONE TO PATIENT, JUST A DELAY IN CASE TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14874834 ↗MalfunctionMay 31, 2022Defective Device; Defective Device
AN ADMINISTRATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WAS DAMAGED AND HAD TO BE CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14546429 ↗
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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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