Clareon™ CNA0T0 (REF CNA0T0.255)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Quick summary
This Alcon Clareon CNA0T0 is a foldable artificial lens implanted in the eye during cataract surgery, delivered through a preloaded injector. The 58 reports mostly describe delivery problems during surgery — the lens sticking in the injector, unfolding before it goes in, the plunger jamming, and packaging parts torn or damaged — so surgeons sometimes had to switch to another lens. Seven injuries were reported, with no deaths. No recalls name this device, and reports in the last 12 months (12) are fewer than the 20 in the prior year.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00380652396448), received between Dec 23, 2021 and Sep 15, 2026 — classified as 7 injuries, 52 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 Eject8
- Device Damaged by Another Device7
- Defective Device6
- Failure to Advance6
- Failure to Deliver6
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Insufficient Information29
- No Clinical Signs, Symptoms or Conditions24
- Capsular Bag Tear3
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Edema1
- Keratitis1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Unfold or Unwrap
A health care professional reported that after the intraocular lens (IOL) implantation surgery, the leading haptic stuck to the posterior side of the optic. The surgeon was very unhappy about having to manipulate the lens so close to the capsule. The surgery was completed on the same day and the lens was left implanted. Additional information was received stating that it was unknown if there was any patient harm.
Patient problems: Insufficient Information
MAUDE report 50775822 ↗MalfunctionAug 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514713 ↗MalfunctionAug 14, 2026Failure to Advance
Patient problems: Insufficient Information
MAUDE report 50253516 ↗MalfunctionAug 10, 2026Device Difficult to Setup or Prepare
A nurse reported that during an intraocular lens (IOL) implant procedure, the IOL unfolded prior to insertion and was not implanted.Additional information was requested and received, stating that when injecting the IOL, the surgeon reported that increased pressure and/or incorrect positioning of the introducer had made it difficult for the lens to be introduced into the eye. As a result, the lens had begun to unfold during insertion, and it was considered safer not to implant the lens. Therefore, the surgeon ruled this to be a user error and not necessarily a fault of the introducer itself.
Patient problems: Insufficient Information
MAUDE report 50191012 ↗MalfunctionJul 30, 2026Inaccurate Delivery
Patient problems: Insufficient Information
MAUDE report 50086132 ↗MalfunctionMay 29, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT IMPLANT FOUND TO BE STUCK IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 25329220 ↗MalfunctionApr 1, 2026Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY IT WAS NOTICED THAT THE LENS WAS FOUND DEFECTIVE, THE HAPTIC ELEMENT IN THE CONTAINER WAS TORN OFF. SURGERY WAS COMPLETED BY USING ANOTHER IOL (INTRAOCULAR LENS) WITHOUT ANY PATIENT HARM. THERE WAS NO PATIENT CONTACT WITH THE SUSPECT DEVICE. CURRENT PATIENT CONDITION IS SATISFACTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751615 ↗MalfunctionMar 7, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PLUNGER WAS OVER-RIDE. THE SURGERY WAS COMPLETED BY USING BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24539869 ↗MalfunctionMar 2, 2026Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24491581 ↗MalfunctionFeb 27, 2026Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION, LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 24468975 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR ERROR.
Patient problems: Insufficient Information
MAUDE report 23850416 ↗MalfunctionNov 27, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER WENT PAST THE LENSES, SO IT WAS NOT ABLE TO GET THE LENS OUT OF THE PATIENT EYE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23665227 ↗MalfunctionNov 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED WITH A DESCRIPTION OF PROCEDURE FAILURE, THE SURGEON HAD DIFFICULTY INSERTING THE IMPLANT INTO THE CAPSULAR BAG OF THE CORNEA. ADDITIONAL INFORMATION WAS RECEIVED STATING RUPTURE OF THE HAPTIC WAS IDENTIFIED DURING THE SURGERY. SULCUS IMPLANT WAS INSERTED CAUSING DIFFICULTY INSERTING THE IMPLANT INTO THE CAPSULAR BAG OF THE CORNEA.
Patient problems: Insufficient Information
MAUDE report 23628526 ↗MalfunctionAug 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE ON IMPLANT CARD VIA REPLY CARD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22738305 ↗MalfunctionJul 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE POTENTIAL PLUNGER ISSUES. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629512 ↗InjuryJul 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 VISUAL DISTURBANCES, POOR CONTRAST SENSITIVITY AND INABILITY TO PERCEIVE SHARP CONTOURS. IMMEDIATELY POST-SURGERY AND ON THE FIRST POSTOPERATIVE DAY, THE PATIENT REPORTED A MARKEDLY WHITISH VISUAL FIELD AND AN INABILITY TO RECOGNIZE ANY OBJECTS. PATIENT REPORTED DISTANCE VISION WAS WHITISH AND PATIENT THOUGHT IT WAS DUE TO CORNEAL SWELLING. THE VISUAL ACUITY OR THE ABILITY TO RECOGNIZE SOMETHING TO SOME EXTENT WAS 30-35 CM. IN THE MEANTIME, THAT WAS INCREASED TO 50-60 CM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING PATIENT UNDERWENT REFRACTIVE CONSULTATION AND THE SYMPTOMS WERE STILL CONTINUING PATIENT WAS PRESCRIBED WITH CORTICOSTEROID MEDICATION AND POST SURGERY TREATMENT. SURGEON STATED SYMPTOMS IMPROVED UPTO 60 PERCENT. ALSO ADVICED TO TAKE READING GLASSES. PATIENT WAS REFRAINED TO DRIVE AT NIGHT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING SYMPTOMS WERE CONTINUING THE OPTOMETRIST MEASURED HIS EYE VALUES AGAIN. THE PRESSURE ON THE OPERATED EYE WAS 16, VISUAL ACUITY SUPPOSEDLY IMPROVED FROM 60% TO 80%. IT IS STILL POSSIBLE TO REA
Patient problems: Blurred Vision; Corneal Edema; Visual Impairment
MAUDE report 22565678 ↗MalfunctionJul 4, 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 LENS EJECTOR MALFUNCTION WAS OBSERVED. THERE WAS NOT ENOUGH VISCOELASTIC IN EJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22403854 ↗MalfunctionJul 4, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE LENS BACKED OUT (STUCK TO THE INJECTOR) OF THE EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22403397 ↗MalfunctionJun 22, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING A PHACOEMULSIFICATION SURGERY THE IOL PLUNGER MISPOSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE, WHICH LED TO ENTRAPMENT, DEFORMATION, AND TEARING OF THE HAPTICS AND OPTICAL PART OF THE IOL AS IT EXITED THE DEVICE. THE COMPANY OVD WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22304596 ↗MalfunctionJun 10, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC CRACKED WHEN THE LENS WAS PUSHED OUT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE FRONT HAPTIC DID NOT FOLD NICELY WHEN THE LENS WAS PUSHED OUT AND THE LENS WAS LEFT IN THE EYE, ONLY THE SMALL PIECE OF HAPTICS WAS REMOVED AND DISCARDED. THE DIAGNOSIS OF THE PATIENT WAS GOOD, THE LENS WAS CENTERED WELL, ALTHOUGH A SMALL PIECE OF THE HAPTIC WAS MISSING. THEE PROGNOSIS WAS VERY GOOD. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22174733 ↗MalfunctionJun 4, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE INTRAOCULAR LENS STUCK IN THE INCISION. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE EDGE WAS TOO NARROW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22141817 ↗MalfunctionMay 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE PROFESSIONAL REPORTED THAT THE LENSES WERE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 21977878 ↗MalfunctionApr 18, 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, THE LENS PLACEMENT WAS FAILED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGERY COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21864041 ↗MalfunctionMar 24, 2025Device Difficult to Setup or Prepare; Activation Problem; Device Difficult to Setup or Prepare; Activation Problem
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE IMPLANT WAS HANDED OFF TO THE SURGEON. THE SURGEON STRUGGLED TO GET THE IMPLANT THROUGH THE INCISION, AND UPON LAYING IT BACK DOWN, THE LENS POPPED OUT OF THE CONTAINER. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. THE LENS HAD PATIENT CONTACT. THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675975 ↗MalfunctionMar 21, 2025Failure to Fold; Inaccurate Delivery; Material Twisted/Bent; Failure to Fold; Inaccurate Delivery; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC ADVANCED STRAIGHT IN THE CARTRIDGE AND EXITED STRAIGHT DOWN AND TO THE RIGHT AND WAS TWISTED. THE SURGEON WOULD EXIT THE WOUND BEFORE THE IOL COULD DELIVER AND REMOVED THE IOL FROM THE CARTRIDGE AND MANUALLY LOADED THE IOL INTO INSERTER. NO PATIENT IMPACT OR HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS FOLDED IN THE INSERTER. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662380 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.