Clareon™ CCA0T0 (UDI 00380652397339)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 CCA0T0 is a foldable artificial lens implanted in the eye during cataract surgery, supplied with an automated pre-loaded delivery system. The 38 reports mostly describe problems with the delivery cartridge during surgery: the lens failing to unfold or eject, jamming against the cornea and having to be cut out and replaced, and being damaged in the box. Four reports involve injuries. There are no recalls naming this device, and the report count is steady at 12 in the past 12 months versus 13 before that.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380652397339), received between Jan 10, 2023 and Sep 26, 2026 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (5 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 Prepare5
- Failure to Deliver5
- Failure to Unfold or Unwrap5
- Particulates3
- Adverse Event Without Identified Device or Use Problem2
- Device Damaged by Another Device2
- Failure to Advance2
- Failure to Eject2
Patient problems
- Insufficient Information23
- No Clinical Signs, Symptoms or Conditions14
- Blurred Vision3
- Eye Injury1
- Photophobia1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 25 most recent of 39 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 50906821 ↗MalfunctionSep 15, 2026Product Quality Problem
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, optic was bent. There was no patient contact, and the procedure was completed on the same day.Additional information has been requested but no information is available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774805 ↗MalfunctionSep 15, 2026Failure to Fold
A health care professional reported that during an intraocular lens (IOL) implant procedure, there was loading error with the pre-loaded device.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50771216 ↗MalfunctionJul 9, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, ERROR WAS OBSERVED IN THE HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25764317 ↗MalfunctionApr 30, 2026Failure to Deliver
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS WASTED BECAUSE IT FAILED TO EJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25045930 ↗MalfunctionApr 24, 2026Device Damaged by Another Device
ADDITIONAL INFORMATION RECEIVED STATING THAT THE BOX WAS OPENED AND WHEN THE DOCTOR WENT TO USE IT NOTICED THE LENS WAS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 24987147 ↗MalfunctionApr 24, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS WASTED - IT DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24982080 ↗MalfunctionJan 22, 2026Material Deformation
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION AND EYE OPTIC HAD A SPLOTCHY ANTERIOR SURFACE HAZE LOOKED LIKE SUBSURFACE NANO GLISTENING, IT IS THROUGHOUT MOST OF THE ANTERIOR SURFACE OF THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24145056 ↗MalfunctionJan 9, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CAME OUT STRAIGHT OR OUT TO THE RIGHT WITH DELIVERY. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24017360 ↗MalfunctionJan 5, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LEVER WAS PRESSED THAT THE LENS DID NOT ADVANCE BUT CONVERSELY, WRAPPED ITSELF AROUND THE BLUE PLASTIC PUSHER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23956508 ↗InjuryDec 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, HAPTIC WAS BROKEN OFF AFTER IMPLANTATION INTO THE PATIENT EYE. THE LENS WAS REMOVED WITH DUET SCISSORS AND A NEW LENS WAS IMPLANTED SUCCESSFULLY IN THE SAME PROCEDURE ALSO A STITCH WAS PLACED AFTER NEW LENS INSERTION. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, DUE TO THE INCISION ENLARGEMENT THE STITCH WAS PLACED. THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 23803657 ↗MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT USED DUE TO A DEFORMATION, IDENTIFIED AS A BENT HAPTIC. THE ISSUE OCCURRED DURING PRIMING THE DEVICE, PRIOR TO IMPLANTATION. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477675 ↗MalfunctionNov 4, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED TO DEPLOY CORRECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23463879 ↗InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 23060863 ↗MalfunctionAug 4, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INCONSISTENT FOLDING, LEADING HAPTIC STUCK TO THE POSTERIOR SIDE OF THE IOL. ALSO STATED THE HAPTIC WAS REMOVED FROM THE OPTIC USING A SECOND INSTRUMENT. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. PROCEDURE WAS COMPLETED AS INTENDED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22700563 ↗MalfunctionJul 31, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INCONSISTENT FOLDING, LEADING HAPTIC STUCK TO THE POSTERIOR SIDE OF THE IOL. ALSO STATED THE HAPTIC WAS REMOVED FROM THE OPTIC USING A SECOND INSTRUMENT. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. PROCEDURE WAS COMPLETED AS INTENDED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22676804 ↗MalfunctionJul 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BOTH LENSES HAD HAPTICS STICKING STRAIGHT OUT AND THE SURGEON DID NOT FEEL COMFORTABLE MOVING ON, SO USED BACKUPS. THE LENSES WERE NOT IMPLANTED, AND THERE WAS NO PATIENT CONTACT OR HARM. ADDITIONAL INFORMATION WAS REQUESTED. THERE WERE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT; THIS REPORT WAS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676197 ↗MalfunctionJul 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BOTH LENSES HAD HAPTICS STICKING STRAIGHT OUT AND THE SURGEON DID NOT FEEL COMFORTABLE MOVING ON, SO USED BACKUPS. THE LENSES WERE NOT IMPLANTED, AND THERE WAS NO PATIENT CONTACT OR HARM. ADDITIONAL INFORMATION WAS REQUESTED. THERE WERE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT; THIS REPORT WAS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676193 ↗MalfunctionJul 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE WHEN THE SURGEON ADVANCED PLUNGER, THE LENS JUST SHOT OUT OF CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22643792 ↗MalfunctionJul 18, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS BECAME STUCK IN THE CARTRIDGE AND FAILED TO ADVANCE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22539765 ↗MalfunctionJul 8, 2025Inaccurate Delivery; Malposition of Device; Inaccurate Delivery; Malposition of Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS KEPT IN THE LOADER INCORRECTLY SO WHEN THE LENS WAS INJECTED IT WENT INTO THE PATIENTS EYE UPSIDE DOWN. THE SURGEON CUT THE LENS INTO HALF TO REMOVE IT. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER COMPANY LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434487 ↗MalfunctionJun 20, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE FRONT HAPTIC OF THE LENS CAME OUT POINTING TO THE RIGHT. SURGEON WAS NOT COMFORTABLE IMPLANTING WITH THE ORIENTATION OF LEADING HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PROCEDURE WAS COMPLETE ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298966 ↗MalfunctionMay 26, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT LEADING HAPTIC ADHERED TO POSTERIOR SURFACE OF OPTIC. THE SURGEONS WERE ABLE TO RELEASE THE HAPTIC. NO PATIENT OUTCOME WAS NEGATIVELY IMPACTED WITH THIS EVENT AND THERE WERE NO DEFECT ON THE OPTIC THAT WOULD IMPACT ANY POST OPERATIVE VISUAL OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084802 ↗MalfunctionMay 26, 2025Malposition of Device; Material Twisted/Bent; Malposition of Device; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS TWISTED AND LENS WAS UPSIDE DOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22084801 ↗MalfunctionMar 19, 2025Activation Problem; Activation Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CONTINUED ADVANCING AFTER STOPPED HOLDING DOWN. IT WAS WASTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21644452 ↗
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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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