Clareon CNWTT0 (UDI 00380652408141)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the Alcon Clareon CNWTT0, a foldable multifocal intraocular lens used in cataract and lens exchange surgery. The 26 reports mostly describe the lens not folding or unfolding properly as it was loaded and inserted, with haptics twisting or detaching, scratches, and the lens sticking or being pulled back out, plus glare, blurred vision and reduced visual sharpness that sometimes led to exchanging the lens. 12 reports describe injuries and 14 malfunctions, with 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
- 26
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652408141), received between Nov 24, 2022 and Aug 27, 2026 — classified as 12 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Scratched Material4
- Material Twisted/Bent3
- Material Deformation2
- Material Split, Cut or Torn2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Crack1
Patient problems
- Insufficient Information12
- Blurred Vision6
- Visual Impairment6
- Visual Disturbances5
- No Clinical Signs, Symptoms or Conditions3
- Eye Injury1
- Halo1
- Posterior Capsule Opacification1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Break; Failure to Unfold or Unwrap; Material Twisted/Bent
A nurse reported that during the presbyopic lens exchange surgery, the lens did not unfold well. No damage was observed on the lens during handling. The haptic was moderately folded in a different position, which was not uncommon. After implantation and unfolding of the IOL, due to the final positioning, the surgeon noted that the anterior haptic to detach from its original location and the haptic adhered to the optic. Hence the lens was explanted during the same procedure and the corneal suture was performed. This caused the surgery to prolong and increased the endothelial stress. The corneal suture led to surgically induced astigmatism. The procedure was completed on the same day.
Patient problems: Eye Injury
MAUDE report 50473473 ↗MalfunctionJul 10, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25776783 ↗MalfunctionJan 12, 2026Failure to Deliver; Inaccurate Delivery
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, 1/8 OF THE LENS GOT STUCK OUTSIDE THE PATIENTS EYE THE SURGEON TRIED PUSHING IT IN USING A NON-COMPANY MANIPULATOR THEN DECIDED TO PULL IT OUT INSTEAD WITH A FORCEPS AND CALL OUT FOR A NEW IOL AS DOES NOT WANT TO TAKE THE RISK OF THE FIRST IOL BEING SCRATCHED ON THE OPTIC. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24037464 ↗MalfunctionNov 25, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS LEG DID NOT FOLD PROPERLY WHILE BEING INSERTED IN THE CARTRIDGE. THE LENS WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23642111 ↗InjuryNov 18, 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 GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 23580101 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC TWISTED WHEN THE LENS WAS BEING PREPARED FOR INSERTION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803791 ↗InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE INSERTED 3 YEARS AGO, THE IOL WAS EXCHANGED FOR UNSPECIFIED NON COMPANY LENS BECAUSE OF MALPOSITION OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT HAD DECREASED VISUAL ACUITY. THE LENS WAS EXCHANGED WITH ANOTHER COMPANY 0.5 DIOPTER LESS POWER LENS AND PATIENT SYMPTOMS WERE RESOLVED POST LENS EXCHANGE.
Patient problems: Blurred Vision
MAUDE report 22737296 ↗MalfunctionJul 22, 2025Material Deformation; Material Deformation
A NON-HEALTH CARE PROFESSIONAL REPORTED A DESCRIPTION, LENS WAS TIGHT DAMAGED ON LOADING. LENS WAS NOT USED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED IN PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22566397 ↗MalfunctionMay 28, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A PLAQUE RESEMBLING PETROL-LIKE STREAKS WAS OBSERVED ON THE SURFACE OF THE IOL. THE SURGEON HAD INITIALLY NOTICED THESE IRIDESCENT STREAKS WHILE LOADING THE LENS INTO THE CARTRIDGE BUT ASSUMED THEY WERE REFLECTIONS CAUSED BY THE UPDATED IOL MATERIAL. UPON SLIT-LAMP EXAMINATION, THE LENS EXHIBITED A BLUE GLOW. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22095785 ↗MalfunctionMar 13, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED A SCRATCH ON IOL OUT OF CENTER, ALIGNED WITH HAPTIC. IOL WAS LEFT IN THE EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY. COMPANY IOL INSERTER AND CARTRIDGE WERE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21597282 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING, AS PER SURGEON THE PATIENT ENQUIRED ABOUT COMPANY LENS PREVIOUSLY AT MULTIPLE CLINICS BEFORE GETTING OPERATED AND DEMANDED TO BE OPERATED WITH THE COMPANY LENS. AFTER IMPLANTATION HE CAME ONLY ONCE FOR FOLLOW-UP AND AS PER SURGEON HIS VISION WAS 6/6 DISTANCE AND N6 NEAR. SURGEON ALSO MENTIONED THAT PATIENT WAS A PHARMA MEDICAL REPRESENTATIVE AND WAS INFORMED ABOUT THE HALOS AND GLARES BEFORE GETTING OPERATED. THE LEFT EYE WAS IMPLANTED WITH 21 DIOPTER COMPANY LENS.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 21592538 ↗MalfunctionMar 3, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION, SCRATCH OBSERVED ON THE IOL. LENS WAS LEFT IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 3 OF 5.
Patient problems: Insufficient Information
MAUDE report 21504548 ↗InjuryJan 22, 2025Adverse 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 EXPERIENCED RIGHT EYE VISION NOT IMPROVING SINCE SURGERY. CLINICAL REASON FOR EXPLANT WAS MECHANICAL BREAKDOWN. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS 1 MONTH 19 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. SURGEON PROGNOSIS WAS GOOD. THE PATIENT ISSUES WERE RESOLVED.
Patient problems: Visual Impairment
MAUDE report 21208457 ↗MalfunctionJan 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN ON INSERTION AND DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21109443 ↗InjuryJan 2, 2025Adverse 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 EXPERIENCED VISION BLURRY AT ALL DISTANCES, TROUBLE SEEING WHILE DRIVING, BOTH NEAR AND FAR VISION NOT AS CRISP. CLINICAL REASON IS PATIENT LEFT -1.0 WITH COMPANY LENS, REFRACTIVE GOAL NOT ACHIEVED. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS 3 MONTHS 20 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21054180 ↗MalfunctionDec 12, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF AFTER IMPLANTING THE INTRAOCULAR LENS IN THE PATIENT EYE THE SURGEON NOTICED A SCRATCH OR MARK ON OPTIC THEN THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20912713 ↗MalfunctionNov 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS OPTIC CHIP. THE SURGEON LEFT LENS IN THE EYE AS CHIP WAS NOT NEAR CENTRAL ZONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20805033 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE PATIENT HAS VISITED THE CLINIC AGAIN WITH EXCELLENT VISION. ADDITIONALLY, IT WAS MENTIONED THAT THE PATIENT STILL GETTING THE FLICKERING TEMPORALLY THOUGH NO ABNORMALITY DETECTED ON MAGNETIC RESONANCE IMAGING (MRI).
Patient problems: Posterior Capsule Opacification; Retinal Degeneration; Visual Disturbances
MAUDE report 20632737 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 19973695 ↗MalfunctionJun 3, 2024Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE EIGHT MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 6 OF 8.
Patient problems: Insufficient Information
MAUDE report 19446915 ↗InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS DECIDED TO EXPLANT FOR PATIENT CARE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT DESPITE OPTIMIZATION POST OP REFRACTIVE ERROR NO PCO PATIENT STRUGGLED WITH DISTANCE VISUAL ACUITY, NEAR VISUAL ACUITY . OPTICAL COHERENCE TOMOGRAPHY IMAGING PERFORMED FOR MACULA AND OPTIC NERVE, CONTACT LENSES OVER REFRACTION DID NOT IMPROVE BEST CORRECTED VISUAL ACUITY PATIENT WAS DISAPPOINTED COULD ALSO NOT TOLERATE GLARE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 19229011 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED WAXY VISION .THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT.. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 19010578 ↗InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED COMPLAINTS OF DIFFICULTY ADAPTING TO DAILY LIFE AND ISSUES WITH LENS ADAPTATION CAUSED BY REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED LENS MODEL WITHIN A MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 18959941 ↗MalfunctionJul 11, 2023Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF LOADING ERROR, INTRAOCULAR LENS (IOL) CRACKED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS PATIENT CONTACT WITH PRODUCT.
Patient problems: Insufficient Information
MAUDE report 17298257 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15967918 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page