Clareon™ CCA0T0 (UDI 00380652397322)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 implant used to replace the eye's natural lens during cataract surgery, delivered through an automated preloaded system. The 28 reports mostly describe delivery problems in the operating room: the lens sticking or slipping past the plunger, haptics bending or twisting, and lenses cracking or scratching as they come out of the device, sometimes requiring a backup lens. Reports mention 4 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
- 28
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00380652397322), received between Jan 6, 2023 and Sep 25, 2026 — classified as 4 injuries, 24 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
- Defective Device4
- Failure to Eject3
- Material Twisted/Bent3
- Break2
- Inaccurate Delivery2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information10
- Eye Injury2
- Blurred Vision1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 28 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 and stated that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 14 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895497 ↗MalfunctionJul 10, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25776778 ↗InjuryMay 22, 2026Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS THAT CRACKED AS IT CAME OUT OF DEVICE. THE LENS WAS CRACKED DOWN THE CENTER OF THE OPTIC. SURGEON REMOVED THE LENS AFTER WIDENING THE INCISION BUT DID NOT BELIEVE ANY REAL PATIENT HARM OUTSIDE OF WIDER INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Eye Injury
MAUDE report 25260014 ↗MalfunctionFeb 27, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BACK HAPTIC DID NOT WORK, IT WAS STUCK ON THE PLUNGER WHILE PRIMING WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472282 ↗MalfunctionFeb 12, 2026Device Difficult to Setup or Prepare
ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A BACKUP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322231 ↗MalfunctionDec 26, 2025Inaccurate Delivery; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS KEPT COMING OUT BY ITSELF. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894554 ↗MalfunctionDec 23, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER SLID OVER THE LENS. NO HARM OCCURRED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876228 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED VISION AND HE CANNOT DRIVE AT NIGHT DUE TO HALOS AND POOR VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 23862923 ↗MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT THE SURGEON HAD AN INTRAOCULAR LENS (IOL) WITH A STRAIGHT TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23801579 ↗MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT THE SURGEON HAD AN INTRAOCULAR LENS (IOL) WITH A STRAIGHT TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23592530 ↗MalfunctionSep 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE LEADING HAPTIC FOLD POSTERIOR TO THE OPTIC AFTER IMPLANTING THE LENS. IN THE SURGEON'S OPINION STATES THAT THE POSTERIOR FOLDED HAPTICS WITH DEVICE HAS BEEN A REOCCURRING ISSUE AND THE LENS REMAINS IMPLANTED. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961431 ↗MalfunctionAug 14, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LOADING ERROR WAS OBSERVED AND PLUNGER WAS SCRATCHED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22808912 ↗MalfunctionAug 11, 2025Failure to Fold; Failure to Fold
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22773248 ↗MalfunctionJul 25, 2025Break; Break
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS PRIMED WITH ROOM-TEMPERATURE COMPANY VISCOELASTIC, THE SURGEON ADVANCED THE LENS, BUT ONLY A HAPTIC CAME OUT AND SHEARED OFF INSIDE OF THE EYE. THE SURGERY WAS COMPLETED THE SAME DAY WITH COMPANY SAME MODEL AND DIOPTER LENS. THERE WAS PATIENT CONTACT. NO HARM CAME TO THE PATIENT. THE WOUND WAS NOT ENLARGED AND NO SUTURE WAS NEEDED. ROOM TEMPERATURE COMPANY VISCOELASTIC WAS USED. THE LENS WAS IN THE VISCOELASTIC LESS THAT THREE MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22619301 ↗MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC WOULD NOT STRAIGHTEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574268 ↗MalfunctionMay 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE AFTER OPENING THE PRODUCT BUT BEFORE ATTEMPTING TO INSERT IT WAS NOTED THAT THE TRAILING HAPTIC WAS NOT FOLDED CORRECTLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992368 ↗MalfunctionApr 18, 2025Failure to Deliver; Failure to Deliver
NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT ADVANCE FROM THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21863969 ↗MalfunctionDec 31, 2024Break; Inaccurate Delivery; Break; Inaccurate Delivery
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DEPLOYED INCORRECTLY. ADDITIONAL INFORMATION HAS RECEIVED IN THE SURGEON¿S OPINION BROKEN HAPTIC WAS CAUSE OF THE EVENT. THERE IS NO IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046442 ↗MalfunctionDec 31, 2024Defective Component; Defective Component
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC BENT. IN THE SURGEON¿S OPINION FAULTY DELIVERY SYSTEM CAUSED THE EVENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046332 ↗MalfunctionDec 10, 2024Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING SURGERY PLUNGER OVERRODE THE LENS WHEN PHYSICIAN TRIED TO IMPLANT WAS NOTICED AND THERE WAS A PATIENT CONTACT. BACKUP LENS WAS PLACED WITHOUT DIFFICULTY. 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 20890664 ↗MalfunctionNov 22, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, VIA REPLY CARD AS MALFUNCTIONED AND NOT IMPLANTED THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20756475 ↗MalfunctionSep 26, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DAMAGED LENS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20309448 ↗MalfunctionMay 24, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENSES DID NOT ADVANCE, INSERTERS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM. THE ORIGINAL PROCEDURE COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391140 ↗MalfunctionApr 25, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, JAMMED INTO INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19179937 ↗MalfunctionNov 7, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18083075 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.