Clareon™ CCA0T0 (UDI 00380652397384)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
Quick summary
This Alcon Clareon intraocular lens is a foldable lens preloaded in an automated injector, used to replace the eye's natural lens during cataract surgery. The 26 reports mostly describe loading and delivery problems during surgery: the lens or its flexible arms arriving bent, twisted or stuck in the injector, so it would not advance or came out misaligned, sometimes forcing the surgeon to open a second lens and lengthen the operation. Three reports describe injuries; no deaths were reported. There are no recalls naming 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
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652397384), received between May 29, 2023 and Sep 30, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare4
- Material Twisted/Bent4
- Failure to Unfold or Unwrap3
- Inaccurate Delivery3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Failure to Eject2
- Particulates2
Patient problems
- Insufficient Information17
- No Clinical Signs, Symptoms or Conditions7
- Visual Disturbances2
- Visual Impairment2
- Blurred Vision1
- Corneal Edema1
- Fibrosis1
- Headache1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the IOL was observed with a chunk missing after it was injected through the injector. The originally scheduled procedure was completed, and the lens was left inside the eye and centered. There was no patient harm.Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945902 ↗MalfunctionJun 5, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC ENDED UP COMING OUT STRAIGHT AND WAS JAMMED BETWEEN THE BLUE PLUNGER AND THE TIP, WITH IT STICKING OUTSIDE OF THE WOUND WHILE ALSO STUCK IN THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25407473 ↗MalfunctionMay 26, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN LOADING LENS GOT STUCK IN CYLINDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25281258 ↗MalfunctionMay 21, 2026Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A TRAJECTORY DEFECT CAUSED BY THE INJECTOR SYSTEM WAS OBSERVED AT THE TIME OF LENS INSERTION. A SECOND IMPLANTATION ATTEMPT WAS PERFORMED USING A COMPANY-PROVIDED LENS OF THE SAME MODEL AND DIOPTER STRENGTH; HOWEVER, THIS ATTEMPT ALSO FAILED DUE TO THE SAME ISSUE. AS A RESULT, THE SURGICAL PROCEDURE TIME WAS PROLONGED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE TRAJECTORY DEFECT WAS ATTRIBUTED TO INCORRECT POSITIONING OF THE IMPLANT IN THE EYE DUE TO THE INJECTOR. THE PROCEDURE WAS PERFORMED ON THE PATIENT¿S RIGHT EYE AND WAS COMPLETED DURING THE SAME SESSION USING THE SAME REFERENCE AND DIOPTER LENS.
Patient problems: Insufficient Information
MAUDE report 25242677 ↗MalfunctionMay 21, 2026Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A TRAJECTORY DEFECT CAUSED BY THE INJECTOR SYSTEM WAS OBSERVED AT THE TIME OF LENS INSERTION. A SECOND IMPLANTATION ATTEMPT WAS PERFORMED USING A COMPANY-PROVIDED LENS OF THE SAME MODEL AND DIOPTER STRENGTH; HOWEVER, THIS ATTEMPT ALSO FAILED DUE TO THE SAME ISSUE. AS A RESULT, THE SURGICAL PROCEDURE TIME WAS PROLONGED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE TRAJECTORY DEFECT WAS ATTRIBUTED TO INCORRECT POSITIONING OF THE IMPLANT IN THE EYE DUE TO THE INJECTOR. THE PROCEDURE WAS PERFORMED ON THE PATIENT¿S RIGHT EYE AND WAS COMPLETED DURING THE SAME SESSION USING THE SAME REFERENCE AND DIOPTER LENS.
Patient problems: Insufficient Information
MAUDE report 25242675 ↗MalfunctionMay 21, 2026Device Difficult to Setup or Prepare; Failure to Advance; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTIC/HAPTIC WAS SEVERELY BENT, THE HAPTIC LOOKED AS IF IT WAS NOT LOADED PROPERLY, ONE LOOKED TO BE BEHIND THE LENS AND THE OTHER WAS STRAIGHT UNABLE FOR LENS TO ADVANCE. FOR PATIENT SAFETY, THE SURGEON OPENED ANOTHER LENS AND DISCARD THAT ONE. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242443 ↗MalfunctionJan 9, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CAME OUT WITH HAPTIC OUT TO THE RIGHT WHEN IMPLANTING. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24017631 ↗MalfunctionNov 28, 2025Failure to Fold; Material Twisted/Bent; Failure to Fold; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC BACK WAS BENT INSIDE OF LOADING DEVICE AND MISLOADED, UNUSABLE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS STARTED BUT STOPPED AND REMOVED BEFORE COMPLETE INSERTION IN THE EYE AND WAS REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671393 ↗MalfunctionNov 26, 2025Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE FRONT HAPTIC WAS NOT LOADED CORRECTLY, WAS DAMAGED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656249 ↗MalfunctionNov 5, 2025Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT THE HAPTIC WAS CRACKED. THE ISSUE OCCURRED WHILE PRIMING THE DEVICE. THE SURGERY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477683 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED SHIMMERING/FLICKERING LIGHTS THAT WERE SUBJECTIVELY CAUSING HEADACHE. THE PATIENT HAD DISCUSSED AND SYMPTOMS WERE ATYPICAL IN NATURE AND ADVISED TO WAIT ANOTHER MONTH AND IF NO IMPROVEMENT, SUGGESTED TO PROCEED WITH IOL EXCHANGE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS NEGATIVE DYSPHOTOPSIA. THERE WAS NO IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Headache; Visual Disturbances
MAUDE report 23475597 ↗MalfunctionJul 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STICKY HAPTICS WERE OBSERVED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 4 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22519021 ↗MalfunctionMay 28, 2025Inaccurate Delivery; Material Twisted/Bent; Inaccurate Delivery; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING , THE LEADING HAPTIC WAS BENT THE OPPOSITE WAY AND PHYSICIAN WANTED TO STOP INJECTING TO ALLOW THE HAPTIC TO UNRAVEL. BUT, THE IOL KEPT DELIVERING EVEN THOUGH PHYSICIAN WAS NOT PRESSING ON THE GAS PEDAL. THE LENS WAS DELIVERED INCORRECTLY, GOT CAUGHT ON THE MALYUGIN RING AND DAMAGED THE IRIS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22096200 ↗InjuryApr 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED THAT, A PATIENT 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 RIGHT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT. 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 RIGHT 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 NSAIDS. RECOMMENDED TO CONTINUE DROPS AND SHIELDS. THE PATIENT STATUS POST CATARACT EXTRACTION 1 DAY OD. THE PATIENT REPORTS THAT HER VISION IS A LITTLE BLURRY, BUT BRIGHTER. THE PATIENT REPORTS FOLLOWING TREATM
Patient problems: Blurred Vision; Corneal Edema; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment
MAUDE report 21749992 ↗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 21696688 ↗MalfunctionMar 20, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTICS ARE STICKING TO THE POSTERIOR LENS SURFACE AND ARE DIFFICULT TO DISLODGE. IOL MANIPULATION IS USED TO RELEASE THE HAPTIC. THE LENSES REMAINED IMPLANTED. THIS CAUSED DELAYS IN SURGERIES. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21652863 ↗MalfunctionFeb 24, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED EXPERIENCING SEVERAL ISSUES WITH THE LEADING HAPTIC STUCK UNDER THE LENS WHEN BEING INJECTED WITH COMPANY INJECTOR. STATED NO NEGATIVE IMPACT TO THE PATIENT BUT IT REQUIRED SEVERAL EXTRA MINUTES OF OPERATION ROOM TIME TO UNSTICK THE HAPTIC. ALL PROCESSES WERE FOLLOWED CORRECTLY IN THE LOADING PROCESS AND IT WAS ADVANCED IMMEDIATELY PRIOR TO INJECTION. INJECTORS ARE NOT AVAILABLE TO RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447364 ↗MalfunctionDec 13, 2024Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING SURGERY WHEN PHYSICIAN ATTEMPTED TO IMPLANT, LENS GOT STUCK IN INCISION. HE COULD NOT GET IT TO GO IN, REMOVED DURING INITIAL PROCEDURE AND PLACED BACK UP LENS WITHOUT COMPLICATION. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT SCHEDULED PROCEDURE COMPLETED THE SAME DAY, PATIENT'S ISSUES RESOLVED AND THERE IS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20922909 ↗MalfunctionDec 12, 2024Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS AMPUTATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20911345 ↗MalfunctionSep 26, 2024Defective Component; Defective Component
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20308290 ↗MalfunctionJun 26, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS MISS FIRED, WOULD NOT LOAD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19612860 ↗MalfunctionDec 11, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL FOUND TO HAVE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18300407 ↗MalfunctionNov 15, 2023Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION (IOL) IT WAS REPORTED THAT IOL WAS BROWN/GOLD IN COLORON THE SURFACE. THE SURGEON EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18141303 ↗MalfunctionJul 20, 2023Particulates; Particulates
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE NOTICED THAT THE LENS SURFACE HAD A COATING OR SHEEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17359907 ↗MalfunctionJul 10, 2023Unintended Ejection; Unintended Ejection
A INVENTORY MANAGEMENT SPECIALIST REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS, WHEN LENS WAS DEPLOYED, IT CAME OUT UPSIDE DOWN. AS THE PATIENT'S EYE WAS TOO SMALL TO MANIPULATE THE LENS, IT WAS REMOVED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17287044 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.