Clareon™ CCA0T0 (UDI 00380652397353)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 CCA0T0 is a sterile foldable posterior-chamber intraocular lens with a preloaded delivery system. The 39 reports mostly describe malfunctions such as a bent or broken haptic, plunger override or failure to advance, and incomplete lens deployment; 4 injuries and no deaths are listed. There are no recalls naming this device identifier. Reports dropped from 20 in the previous 12 months to 11 in the last 12 months.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380652397353), received between Apr 21, 2023 and May 25, 2026 — classified as 4 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (8 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 Prepare8
- Failure to Advance7
- Material Twisted/Bent6
- Failure to Deliver5
- Failure to Unfold or Unwrap4
- Particulates4
- Inaccurate Delivery3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Insufficient Information25
- No Clinical Signs, Symptoms or Conditions13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS IN THE INSERTER AND DID NOT ADVANCE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING UNSPECIFIED NEW LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Insufficient Information
MAUDE report 25270853 ↗MalfunctionMay 19, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT DEPLOY PROPERLY REQUIRING REPLACEMENT WITH SAME TYPE OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25215594 ↗MalfunctionApr 30, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS BENT AND OVERRODE THE LENS. THE PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25044403 ↗MalfunctionMar 16, 2026Device Difficult to Setup or Prepare; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE DEVICE WAS FAULTY AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24603971 ↗MalfunctionMar 11, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS FAULTY AND NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24568714 ↗MalfunctionMar 9, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE WHILE BEING LOADED HAPTIC WAS FOLDED UNDER THE OPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544724 ↗MalfunctionFeb 19, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON USED THIS LENS ON A PATIENT, BUT THE HAPTIC BROKE OFF DURING IMPLANTATION, SO THE HAPTIC WAS LEFT INSIDE THE PATIENT'S EYE AND LENS AND THE SECOND HAPTIC WERE STILL STUCK IN THE INSERTER. THE HAPTIC WAS REMOVED FROM THE PATIENT'S EYE AND A NEW LENS INSERTED. NO ISSUES THE FIRST LENS WAS BEING USED BY THE RESIDENT. THE TRAILING HAPTIC WAS NOT FOLDED INTO THE TACO CONFIGURATION AND WAS TRAILING. NOT USUALLY A PROBLEM, EXCEPT THAT IT SEEMED TO GET WRAPPED AROUND THE BLUE INSERTER AND INSTEAD OF COMING OUT OF THE FRONT WITH THE REST OF THE IOL (IN THE GROOVED PORTION), THE HAPTIC WAS STUCK AROUND THE BACK OF THE BLUE INSERTER BETWEEN THE INSERTER AND THE INNER CLEAR SLEEVE. IT WAS REALLY JAMMED / SQUASHED. SURGEON TRIED TO TEASE IT OUT, BUT THE OUTER BULB WOULD NOT COME OUT, AND IT EVENTUALLY JUST BROKE OFF AND HAD TO CUT THE IOL OUT OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24397815 ↗MalfunctionJan 5, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS NOT IN THE RIGHT ORIENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23957171 ↗MalfunctionDec 19, 2025Inaccurate Delivery; Failure to Advance; Inaccurate Delivery; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER ISSUES HAD BEEN OBSERVED. THE LENS KEPT ADVANCING OUT OF THE PLUNGER.
Patient problems: Insufficient Information
MAUDE report 23854331 ↗MalfunctionNov 7, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498576 ↗InjuryOct 31, 2025Failure to Deliver; Inaccurate Delivery; Failure to Deliver; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS WEDGED IN PRIMARY INCISION AND HAD TO BE CUT OUT, INCISION MADE BIGGER AND THEN REPLACEMENT LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23438733 ↗InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS SUBLUXED. THE LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23299497 ↗MalfunctionOct 15, 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, AFTER PREPARING THE IOL THE SURGEON WENT TO INSERT THE LENS NOTICED THAT LEADING HAPTIC WAS ALREADY COMING OUT OPTED NOT TO IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279947 ↗MalfunctionSep 12, 2025Particulates; Device Difficult to Setup or Prepare; Particulates; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS A PLASTIC RING THAT CAME OUT WHEN THE LENS WAS GETTING READY TO BE INJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035456 ↗MalfunctionSep 2, 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 WAS CRUMPLED UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE OCCURRED DURING LOADING. IN SURGEON OPINION THE WAY THE LENS SAT IN THE CARTRIDGE AS IT IS PRELOADED CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936333 ↗MalfunctionAug 19, 2025Break; Crack; Break; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS OPTIC BROKEN/CRACKED/SPLIT/TORN. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22846490 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, A COUPLE OF PRE-LOADED LENSES CAME OUT WITH THE LEADING HAPTICS TWISTED BELOW THE OPTIC, ALMOST FLIPPING THE IOL IN CASES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22749691 ↗MalfunctionAug 1, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE INJECTOR OVERRODE LENS. THERE WAS NO MORE INFORMATION ABOUT THE PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE
Patient problems: Insufficient Information
MAUDE report 22687415 ↗MalfunctionJun 20, 2025Particulates; Failure to Deliver; Particulates; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN IOL (INTRAOCULAR LENS) IMPLANTATION SURGERY, A SMALL PLASTIC RING WAS LOOPED AROUND THE TRAILING HAPTIC CAUSING THE IOL TO GET HUNG UP AT INSERTION. THE IOL WAS PULLED AND THE RING WAS REMOVED FROM TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS WAS IMPLANTED WITH NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 22298837 ↗MalfunctionJun 18, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT ONE OF THE PRELOADED WAS MISSING THE IMPLANT, ONE HAPTIC WAS MESSED UP. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE HAPTIC CAME OUT STRAIGHT OR TWISTED. IT WAS ALSO STATED THAT THERE WAS NO PATIENT CONTACT TO THE DEVICE. THERE ARE 3 FILES ASSOCIATED WITH THIS COMPLAINT. THIS FILE BELONGS TO 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 22285954 ↗MalfunctionJun 18, 2025Device Difficult to Setup or Prepare; Inaccurate Delivery; Device Difficult to Setup or Prepare; Inaccurate Delivery
A NURSE REPORTED THAT DURING SURGERY, INJECTOR MISFIRED NOTED WHILE LENS BEING INSERTED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284524 ↗MalfunctionJun 2, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS STUCK TO POSTERIOR SURFACE OF OPTIC. THE SURGEON TRIED TO MANIPULATE WITH FORCEPS AND ALSO WITH IA (IRRIGATION AND ASPIRATION) NOTHING WORKED IN BAG. THE LENS WAS VAULTED IN ANTERIOR CHAMBER AND HAD TO PEEL WITH FORCEPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22125003 ↗MalfunctionMay 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22069211 ↗MalfunctionMay 15, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LEADING HAPTIC WAS ADHERED TO THE POSTERIOR SIDE OF THE OPTIC. THE SURGEON WAS ABLE TO RELEASE THE HAPTIC FROM THE POSTERIOR ASPECT OF THE OPTIC AFTER USING ADDITIONAL INSTRUMENTS, WHICH ADDED EXTRA TIME TO THE PROCEDURE AND THE RISK OF WORKING ON THE POSTERIOR SIDE OF THE LENS AFTER IMPLANTATION. NO PATIENTS OUTCOMES WAS NEGATIVELY IMPACTED WITH THIS EVENT AND THERE WAS NO DEFECTS ON THE OPTIC THAT WOULD IMPACT ANY POST OPERATIVE VISUAL OUTCOME AND THE LENS REMAIN IMPLANTED IN THE PATIENT'S EYE. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026294 ↗MalfunctionApr 22, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT DEPLOY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21881554 ↗
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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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