Clareon™ CCA0T0 (UDI 00380652397346)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 Clareon intraocular lens is inserted into the eye using a preloaded delivery system. Its 41 reports mostly describe trouble preparing the system, lenses getting stuck or failing to unfold or eject, and supporting arms bending; 39 reports involve device malfunctions. The reports mention 2 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
- 41
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00380652397346), received between Aug 30, 2022 and Sep 25, 2026 — classified as 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (11 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 Prepare11
- Failure to Advance5
- Failure to Eject5
- Failure to Unfold or Unwrap5
- Failure to Deliver4
- Failure to Fold3
- Material Twisted/Bent3
- Defective Device2
Patient problems
- Insufficient Information23
- No Clinical Signs, Symptoms or Conditions18
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received stating there has been no visual impact to patients.There are multiple medical reports associated with same event. This file is 4 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899134 ↗MalfunctionSep 4, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, haptic was kinked. There was no patient contact. The procedure was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615860 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON ATTEMPTED TO INSERT THE LENS INTO THE PATIENT¿S EYE, BUT THE FRONT HAPTIC CAME OUT BEFORE THE LENS COULD BE INSERTED. THERE WAS PATIENT CONTACT HOWEVER, THE LENS REMAINED HALFWAY IN THE CARTRIDGE AND WAS NEVER FULLY IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982982 ↗MalfunctionApr 22, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS APPEARED TO BE STUCK. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24953142 ↗MalfunctionMar 6, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) PUSHER SLID PAST. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE OCCURRED DURING LOADING WITH TIP OF THE PRE-LOADED DEVICE IN CONTACT WITH THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24528198 ↗MalfunctionFeb 13, 2026Material Twisted/Bent
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS KINKED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333378 ↗MalfunctionFeb 11, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE INJECTOR. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24311964 ↗MalfunctionFeb 9, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTICS DID NOT FOLD DURING LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292120 ↗MalfunctionJan 14, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT THE PLUNGER WOULD NOT GRAB THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068793 ↗MalfunctionJan 12, 2026Device Damaged by Another Device
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 24034789 ↗MalfunctionDec 31, 2025Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23932623 ↗MalfunctionDec 1, 2025Failure to Fold; Device Difficult to Setup or Prepare; Failure to Fold; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC FOLDED WRONG, UNABLE TO USE LENS, SURGEON FELT LENS FOLDED INCORRECTLY IN DEVICE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679367 ↗MalfunctionNov 24, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC STUCK TO SPHERICAL POSTERIOR LENS SURFACE. SURGEON TOOK APPROXIMATELY FIVE MINUTES TO DETACH IT, WITH NO CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631382 ↗MalfunctionOct 22, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC GOT WEDGED BETWEEN PLUNGER AND NOZZLE AND STUCK. IT WAS ALSO STATED THAT SURGEON HAD TO PRY IT OUT WITH KUGLEN TO FREE THE LENS. AND MENTIONED THAT LENS IMPLANTED BUT THERE WAS ONE SMALL SCRATCH ON PERIPHERY ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23356453 ↗MalfunctionOct 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LEADING HAPTIC WAS OUT DURING PRIMING WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23273766 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE IMPLANTING THE LENS, THE SURGEON NOTICED THAT THE CAPSULE HAD TORN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND A NEW LENS WAS INSERTED INTO THE SULCUS. THE SURGERY WAS COMPLETED THE SAME DAY USING THE NON-COMPANY LENS AND THE WOUND WAS ENLARGED AND SUTURE WAS USED TO CLOSE THE WOUND. THE SURGEON DOES NOT FEEL THAT THE CAPSULE RUPTURE WAS PRODUCT RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23095046 ↗MalfunctionSep 10, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016586 ↗MalfunctionSep 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE TAIL END OF THE HAPTIC GOT STUCK IN THE LENS LOADER AND WOULD NOT DETACH. LATER IT CAME OFF BUT THE DOCTOR FELT THAT, THE HAPTIC WAS NOT GOOD TO KEEP IMPLANTED. SO THE LENS WAS EXPLANTED AND BACK UP LENS WAS IMPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001823 ↗InjurySep 5, 2025Failure to Fold; Device Difficult to Setup or Prepare; Material Twisted/Bent; Failure to Fold; Device Difficult to Setup or Prepare; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BACK HAPTIC WAS TRAILING AND STUCK TO THE PLUNGER. THEY ENDED UP HAVING TO CUT IT OUT AND USE ANOTHER COMPANY LENS INSTEAD. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LEADING HAPTIC WAS FOLDED INCORRECTLY, INSTEAD OF FOLDED ON THE OPTIC IT WAS PROTRUDING STRAIGHT OUT FROM THE OPTIC. THE TRAILING HAPTIC THEN GOT STUCK IN THE INJECTOR. WHILE TRYING TO FREE THE TRAILING HAPTIC, THE LEADING HAPTIC CAUSED A POSTERIOR CAPSULE TEAR AND THE CAPSULE COULD NO LONGER SUPPORT THE 1 PIECE IOL. LENS WAS REMOVED AND REPLACED WITH A 3 PIECE COMPANY IOL.
Patient problems: Capsular Bag Tear
MAUDE report 22976775 ↗MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PLUNGING OUT THE LENS WAS INVERTED BEFORE IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22921016 ↗MalfunctionJul 11, 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, IT WAS NOTED THAT THE LEADING HAPTIC STUCK UNDERNEATH THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22480642 ↗MalfunctionJul 10, 2025Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK AND WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGERY CONTINUED WITH SAME MODEL COMPANY LENS BUT THE HAPTIC TORE OFF UPON INSERTION. THE LENS WAS CUT AND REMOVED FROM THE PATIENT'S EYE AND THE SURGERY COMPLETED WITH REPLACEMENT LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 22469882 ↗MalfunctionJun 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC DAMAGED OR JAMMED IN DELIVERY SYSTEM. THE PROCEDURE COMPLETED SAME DAY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE LENS REMAINED IN DELIVERY SYSTEM. THERE WAS NO PATIENT HARM. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306770 ↗MalfunctionJun 6, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK AND WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 22157102 ↗MalfunctionJun 6, 2025Break; Break
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGERY COMPLETED WITH REPLACEMENT LENS OF SAME MODEL AND DIOPTER.
Patient problems: Insufficient Information
MAUDE report 22157096 ↗
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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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