Clareon™ CCA0T0 (UDI 00380652397315)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 plastic lens used to replace the eye's natural lens during cataract surgery, supplied in an automated pre-loaded cartridge. The 27 reports mostly describe delivery problems during implantation: the cartridge plunger pushing past or skipping over the folded lens so it would not advance or deploy, the lens sticking or coming out the wrong way, a haptic arm breaking or protruding, and particles or scratches. One report involved an injury. 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00380652397315), received between Jul 14, 2022 and Sep 15, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance5
- Failure to Deliver5
- Device Damaged by Another Device3
- Failure to Eject3
- Particulates3
- Failure to Unfold or Unwrap2
- Scratched Material2
- Activation Problem1
Patient problems
- Insufficient Information17
- No Clinical Signs, Symptoms or Conditions10
- 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 15, 2026Failure to Deliver
A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the IOL did not deploy correctly during insertion with patient contact.Additional information was requested but was not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50774468 ↗MalfunctionMay 25, 2026Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PLUNGER WENT PAST LENS WHEN LOADING THE LENS AND LENS GOT FOLDED AND THE PROCEDURE WAS SCRUBBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25271086 ↗MalfunctionApr 17, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24910746 ↗MalfunctionApr 7, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER TIP PUSHED THE LENS AND BYPASSED THE IOL. LENS DID NOT MOVE FORWARD. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802458 ↗MalfunctionFeb 18, 2026Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NURSE REPORTED THAT THE HAPTIC BROKE OFF WHILE IT WAS IN THE AUTOMATIC CARTRIDGE. HOWEVER, THE NURSE WAS ABLE TO DISLODGE IT AND RE-LOAD IT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24376377 ↗MalfunctionFeb 16, 2026Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, LENS STUCK IN LOADER. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24344555 ↗MalfunctionJan 29, 2026Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OVER ROAD THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24208627 ↗MalfunctionJan 8, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME OUT STRAIGHT OR WENT OUT TO THE RIGHT DURING DELIVERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24004452 ↗MalfunctionNov 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS STICKING OUT SO THOUGHT IT TO BE TORN. THE LENS WAS NOT USED AND THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED THAT THE LENS WAS STICKING OUT WHEN THE PACKAGE WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630769 ↗MalfunctionNov 3, 2025Particulates; Scratched Material; Particulates; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS INSERTED AND APPEARED TO HAVE A SCRATCH ACROSS THE OPTIC SURFACE. THE SURGEON PROCEEDED TO CUT THE LENS IN HALF FOR REMOVAL. DURING THIS PROCESS, A BAND OF MATERIAL WAS RELEASED FROM THE LENS, WHICH SPANNED THE ENTIRE WIDTH OF THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 23451826 ↗MalfunctionOct 16, 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, SURGEON WAS ADVANCING THE LENS, HE NOTICED THE LENS WAS IN AN AWKWARD POSITION AS HE ADVANCED IT. HE DECIDED NOT TO IMPLANT IT BECAUSE OF ODD POSITION IN THE INJECTOR. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311797 ↗MalfunctionJul 31, 2025Activation Problem; Activation Problem
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN IOL WAS ADVANCING AT USUAL CONTROLLED STEADY PACE, THE PLUNGER SHOT OUT SUDDENLY MUCH FURTHER THAN USUAL CAUSED THE LENS TO ADVANCE EVEN FURTHER SUDDENLY. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676444 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PUSHER WAS ABOVE THE LENS AND THE LENS DID NOT COME OUT OF THE DELIVERY SYSTEM. THERE WAS A PATIENT CONTACT, AND THE LENS DID NOT DEPLOY IN THE INCISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PLUNGER WENT ABOVE THE LENS AND THE LENS DID NOT COME OUT OF THE DELIVERY SYSTEM.
Patient problems: Insufficient Information
MAUDE report 22668868 ↗MalfunctionJul 14, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK AND WOULD NOT ADVANCE OR PASS PLUNGER. THE LENS WAS INSERTED AND REMOVED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495351 ↗MalfunctionMay 27, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC ADHERED TO POSTERIOR SURFACE OF OPTIC. THE SURGEONS WERE ABLE TO RELEASE THE HAPTIC. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088391 ↗MalfunctionDec 12, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED, HOLE IN CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20916364 ↗MalfunctionDec 12, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FRONT HAPTIC WAS STUCK UNDERNEATH THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 4.
Patient problems: Insufficient Information
MAUDE report 20915954 ↗MalfunctionNov 21, 2024Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT THE INTRAOCULAR LENS (IOL) SCRATCHED IN THE CENTER. NO PATIENT IMPACT WAS REPORTED. FOLLOW-UP INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748194 ↗InjuryApr 26, 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 HAD NO DISTANCE VISION, RESIDUAL REFRACTIVE ERROR WITH HARD TIME DRIVING BOTH DAY AND NIGHT. ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PATIENT TRIED A CONTACT LENSES WITH THE RIGHT CORRECTION AS A TEST AND THE FIRST TRY WAS TERRIBLE AND VERY BLURRY.
Patient problems: Visual Impairment
MAUDE report 19192295 ↗MalfunctionApr 25, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER OVER RIDE THE HAPTIC AND LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19181147 ↗MalfunctionMar 26, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF PLUNGER WENT PAST THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PLUNGER WENT PAST THE LENS. THE IOL WAS NOT IMPLANTED. THERE WAS NO PATIENT HARM. THE PROCEDURE COMPLETED THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18977686 ↗MalfunctionFeb 29, 2024Particulates; Particulates
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER INJECTION OF THE LENS INTO THE LENS CAPSULE, THE PHYSICIAN NOTICED A BLUE COLORED FILAMENT OR STRAND ADHERING TO THE LENS. THE PHYSICIAN STATED THAT BLUE COLOR IS SIMILAR TO THE LOCK OUT ASSEMBLY AND PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18811831 ↗MalfunctionDec 6, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, LARGE SCRATCH/ARTIFACT WAS NOTED AFTER THE LENS UNFOLDED, HAD TO CUT THE LENS IN HALF AND REMOVE AND REPLACE IT WITH A NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18278957 ↗MalfunctionNov 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REFRACTIVE SURPRISE POST OPERATIVELY, LENS COULD HAVE BEEN LABELED WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED FROM PHYSICIAN STATING THE PATIENT WAS DOING WELL WITH A SIX CORRECTION LOGIC (SCL) CORRECTION. HE HAD MOST EXPERIENCED CORNEA/REFRACTIVE REVIEW THE CASE AND HE WAS CONFIDENT FUTURE PTK LEFT EYE (OS) UPON THE PATIENT'S RETURN LATE SPRING WILL RESULT IN A SATISFACTORY OUTCOME. THE CHANCES OF A MISLABELED IOL IN MANUFACTURING PROCESS WAS EXTREMELY LOW. MOST LIKELY THE ISSUE WAS THE VERY DIFFERENT K TOPOS BETWEEN HER OD (EXCELLENT EXPECTED RESULT) AND OS (REFRACTIVE SURPRISE). THE TOPO OS CERTAINLY HAS A PELLUCID MARGINAL DEGENERATION APPEARANCE WHICH WE ALL KNOW CAN HAVE WILDLY UNPREDICTABLE REFRACTIVE RESULTS GIVEN THE HIGH RATE OF K SLOPING CLOSE TO THE VISUAL AXIS.
Patient problems: Visual Disturbances
MAUDE report 18204705 ↗MalfunctionNov 20, 2023Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) JAMMED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18168609 ↗
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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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