Clareon™ CCA0T0 (UDI 00380652397377)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, delivered through a pre-loaded injector. The 29 reports mostly describe loading and delivery problems with the injector — the lens failing to load or advance, the injector or tip bending, and the lens or its haptic breaking, sometimes forcing the surgery team to open a second lens. Reports mention 2 injuries. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380652397377), received between Jul 5, 2023 and Sep 4, 2026 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare6
- Failure to Advance6
- Device Damaged by Another Device4
- Failure to Deliver3
- Adverse Event Without Identified Device or Use Problem2
- Failure to Eject2
- Failure to Fold2
- Failure to Unfold or Unwrap2
Patient problems
- Insufficient Information18
- No Clinical Signs, Symptoms or Conditions10
- Blurred Vision1
- Headache1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Device Damaged by Another Device
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, Haptic issue was observed. Additional information has been received and stated, while loading, noticed haptic was advanced and did not use. In the surgeon¿s opinion, the loader contributed to or caused the event. The procedure was completed on the same day without any impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50606576 ↗MalfunctionApr 28, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE DELIVERY SYSTEM FAILED, DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25017148 ↗MalfunctionApr 6, 2026Failure to Deliver
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE LENS WAS REPLACED WITH THE SAME COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 24791503 ↗MalfunctionApr 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THEY OBSERVED THAT THE DEVICE WAS DEFECTIVE. IT WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24768029 ↗MalfunctionMar 26, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device
ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED STATED THAT THE HAPTIC WAS BROKEN INTO THE INJECTOR. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT OCCURRED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24696718 ↗MalfunctionFeb 9, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE BLUE INJECTOR WAS FOUND TO BE BENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24292122 ↗MalfunctionJan 23, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PLUNGER WENT PASSED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24161812 ↗MalfunctionJan 5, 2026Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION PROCEDURE THE TIP WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23960911 ↗MalfunctionDec 1, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED INTO THE EYE, THE INJECTOR PISTON BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS A PATIENT CONTACT. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23679548 ↗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 RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Headache; Visual Disturbances
MAUDE report 23475596 ↗MalfunctionSep 18, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WOULDN¿T COME OUT THEN IT RIPPED IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23082438 ↗MalfunctionSep 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, A REAR HAPTIC WAS FOLDED IMPROPERLY WAS NOTICED ON THE LENS DURING LOADING, WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026162 ↗MalfunctionAug 28, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A FINE FILM ON THE ANTERIOR SURFACE OF THE IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22911479 ↗MalfunctionAug 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22717155 ↗MalfunctionAug 1, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC WAS CAUGHT ON THE PLUNGER SO A SECOND INSTRUMENT WAS NEEDED TO DISENGAGE THE HAPTIC, LENS WAS FOLDED BUT GOT CAUGHT. THERE WAS NO PATIENT ISSUE AND SURGERY WAS COMPLETED AS PLANNED. LENS WAS LOADED ONE MINUTE BEFORE IMPLANTATION WITH A COMPANY VISCOELASTIC AT ROOM TEMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685515 ↗MalfunctionJul 15, 2025Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON TRIED ADVANCING THE LENS INTO THE EYE, THE FRONT HAPTIC BROKE IN TWO. THE PROCEDURE COMPLETED THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507647 ↗MalfunctionMay 24, 2025Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE PLUNGER ROD WENT OVER THE IOL NOT ADVANCING THE IOL DOWN THE BARREL. THIS IOL WAS DISCARDED AND NOT USED, ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22081939 ↗MalfunctionApr 4, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED ABOUT A LENS DID NOT ADVANCE AS EXPECTED DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE. THERE WAS PATIENT CONTACT AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774114 ↗MalfunctionMar 26, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LEADING HAPTIC WAS STICKING TO THE POSTERIOR SIDE OF THE OPTIC NOT TRAILING HAPTIC.
Patient problems: Insufficient Information
MAUDE report 21696690 ↗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 3 OF 3.
Patient problems: Insufficient Information
MAUDE report 21445673 ↗MalfunctionSep 3, 2024Unintended Ejection; Failure to Fold; Unintended Ejection; Failure to Fold
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOLDED LIKE A TACO AND OPENED UPSIDE DOWN AND HE HAD TO FLIP IT. THE LENS WAS FINE, PATIENT WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20129400 ↗MalfunctionSep 3, 2024Unintended Ejection; Failure to Fold; Unintended Ejection; Failure to Fold
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOLDED LIKE A TACO AND OPENED UPSIDE DOWN AND HE HAD TO FLIP IT. THE LENS WAS FINE, PATIENT WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127347 ↗MalfunctionJul 16, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE , LENS WAS OVERFILLED AND WOULD NOT STOP ADVANCING. ADDITIONAL INFORMATION RECEIVED THAT IT HAPPENED AS THE VISCOELASTIC WAS USED TO FILL THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 19751174 ↗MalfunctionJun 3, 2024Defective Component; Failure to Eject; Defective Component; 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 WAS RECEIVED AND IT WAS THE LEADING HAPTIC THAT WAS STUCK TO THE POSTERIOR SIDE OF IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19448354 ↗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 18893159 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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