Clareon™ CCA0T0 (UDI 00380652397360)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon intraocular lens is an artificial lens implanted in the eye, sold preloaded in an automated injector. Reports mostly describe the lens failing to load, advance or unfold properly during surgery, sometimes requiring a replacement lens, with some mentioning blurred vision afterward. There are 24 reports naming its identifier, including 6 injuries and no deaths. No recalls name this device, with reports down from 12 to 5 in the last 12 months.
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
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652397360), received between Jan 6, 2023 and Sep 15, 2026 — classified as 6 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare9
- Adverse Event Without Identified Device or Use Problem3
- Device Damaged by Another Device2
- Failure to Eject2
- Failure to Unfold or Unwrap2
- Material Discolored2
- Break1
- Defective Component1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions10
- Blurred Vision6
- Visual Impairment3
- Corneal Edema1
- Eye Pain1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that, during cataract surgery with an intraocular lens implant procedure, front haptic issue was found. There was no patient contact and the procedure was completed the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775539 ↗MalfunctionApr 15, 2026Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DIDN'T UNFOLD EASILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS LEFT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24891989 ↗MalfunctionFeb 27, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PRELOADED DEVICE MALFUNCTIONED. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24469980 ↗MalfunctionJan 9, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE AND INNER DEVICE WAS BENT OR CURVED TO PREVENT LENS FROM BEING IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24021441 ↗MalfunctionDec 15, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS LOADED WAS CROOKED AND NOTICED WHEN THE SCRUB TOOK IT OUT OF THE BOX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23803651 ↗MalfunctionNov 19, 2025Failure to Prime; Product Quality Problem; Failure to Prime; Product Quality Problem
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT LOAD PROPERLY. LENS HAD COME OUT STRAIGHT AND NOT CURVED. LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED STATING EVENT HAS HAPPENED DURING LOADING THE LENS. THERE WAS NO PATIENT CONTACT WITH THE TIP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594524 ↗MalfunctionOct 17, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS BEING PREPARED TO BE INSERTED, THE SURGEON NOTICED AN ABNORMALITY WITH DELIVERY SYSTEM THE WAY IT WAS CURVED AND WOULD NOT BE INSERTED CORRECTLY. BACKUP LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23322246 ↗MalfunctionAug 14, 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 FOLD WAS INCORRECT AND THEY HAD A BAD HAPTIC. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803535 ↗MalfunctionAug 13, 2025Failure to Fold; Device Difficult to Setup or Prepare; Failure to Fold; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE FOLD WAS INCORRECT AND HAD A BAD HAPTIC. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795896 ↗MalfunctionAug 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THERE WAS A PROBLEM WITH THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 22773463 ↗MalfunctionAug 8, 2025Break; Scratched Material; Break; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC TORN OR BROKEN, AND PLUNGER SCRATCHED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22750099 ↗MalfunctionJul 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED THAT THE LENS DID NOT FIRE CORRECTLY BUT THEY WERE ABLE TO GET IT TO WORK AND USED THE LENS. IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22517857 ↗MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC WAS STRAIGHT (NOTICED PRIOR TO INSERTION). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864778 ↗InjuryApr 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED THAT, PATIENT WITH A STATUS POST LASIK WHO UNDERWENT CATARACT SURGERY WITH THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHO TARGETED FOR PLANO, ENDED UP WITH A MYOPIC SURPRISE ABOUT -3.75 WITH SOME MINOR CYLINDER IN THE LEFT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT BEING SEEN FOR FOLLOW-UP POSTOP SURGERY STATUS POST CATARACT EXTRACTION WITH IOL AND MLRIS (WITH MONOFOCAL DISTANCE) OF THE LEFT LENS. THE SURGERY WAS PERFORMED ON 1 DAY OD, 1 WEEK OS. SINCE THE SURGERY, THE PATIENT HAS NOTICED THAT COLORS APPEAR MORE VIVID AND OBJECTS APPEAR BRIGHTER IN THE AFFECTED EYE. THE PATIENT HAS SLEPT WITH AN EYE SHIELD AND TAKEN EYE MEDICATIONS AS PRESCRIBED. THE PATIENT IS TAKING THE FOLLOWING MEDICATIONS IN THEIR RIGHT EYE: CORTICOSTEROID, ANTIBIOTIC AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). RECOMMENDED TO CONTINUE DROPS AND SHIELDS. THE PATIENT STATUS POST CATARACT EXTRACTION 1 DAY OS. THE PATIENT REPORTS THAT SHE HAS MINOR PAIN BUT FELT THIS AS
Patient problems: Blurred Vision; Corneal Edema; Eye Pain; Visual Disturbances; Visual Impairment
MAUDE report 21749946 ↗MalfunctionJan 13, 2025Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT LENS WAS MISFIRED ON THE SURGICAL FIELD. THE SURGEON SAID LENS WAS TWISTED IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21135860 ↗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 4 OF 4.
Patient problems: Insufficient Information
MAUDE report 20912691 ↗MalfunctionDec 7, 2024Defective Component; Defective Component
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS MISSING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20873469 ↗MalfunctionNov 21, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS SCRATCHED WHEN IT WAS UNFOLDED IN THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20742418 ↗MalfunctionSep 13, 2024Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS STUCK IN INJECTOR, WOULD NOT DEPLOY. NEW LENSES OBTAINED AND USED FOR CASE, CASE COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20213085 ↗InjuryApr 2, 2024Material Discolored; Material Discolored
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD CLEAR VISION INITIALLY DAY 1 (20/30) BUT THEN A DECLINE IN ACUITY TO 20/50 BY WEEK 2. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS NORMAL AND NO IMPROVEMENT WITH REFRACTION. WHEN THEY DILATED HER AT WEEK 2 THERE WAS A HAZY CRYSTALLINE SHEEN WITHIN THE CENTRAL LENS MATERIAL INFERIORLY AND EXTENDING INTO THE CENTRAL AXIS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 19018640 ↗InjuryMar 13, 2024Adverse 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 WAS EXPERIENCING DIFFICULT TO SEE AND DIFFICULT TO READ, THINGS APPEARED TO BE DARK. PATIENT WAS PUT ON AREDS2 VITAMINS AND USING GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18893160 ↗InjuryJan 22, 2024Material Discolored; Material Discolored
A NURSE REPORTED THAT FOLLOWING AN INTRA-OCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD CLEAR VISION INITIALLY DAY 1 (20/30) BUT THEN A DECLINE IN ACUITY TO 20/50 BY WEEK 2. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS NORMAL AND NO IMPROVEMENT WITH REFRACTION. WHEN THEY DILATED HER AT WEEK 2 THERE WAS A HAZY CRYSTALLINE SHEEN WITHIN THE CENTRAL LENS MATERIAL INFERIORLY AND EXTENDING INTO THE CENTRAL AXIS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 18551062 ↗MalfunctionJul 5, 2023Particulates; Particulates
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY INTRAOCULAR LENS HAD SHEEN OR COATING ON THEM THAT WAS DIFFERENT. THERE ARE SIX MEDICAL REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 6. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17255097 ↗InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF BLIND SPOT IN CENTER OF VISION BEGINNING ONE WEEK POST OPERATION FOR EACH EYE. THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16128712 ↗InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF BLIND SPOT IN CENTER OF VISION BEGINNING ONE WEEK POST OPERATION FOR EACH EYE. THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16113926 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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