Clareon CNWTT0 (UDI 00380652408172)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 Clareon multifocal intraocular lens is implanted in the eye. Reports mostly describe broken or scratched lenses, difficulty inserting them, and vision problems; some lenses were removed or replaced. There are 24 reports, 14 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
- 26
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652408172), received between Nov 1, 2022 and Sep 29, 2026 — classified as 16 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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 Problem12
- Break5
- Scratched Material4
- Defective Device2
- Device Dislodged or Dislocated2
- Failure to Eject2
- Crack1
- Device Damaged by Another Device1
Patient problems
- Blurred Vision8
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions6
- Visual Disturbances6
- Visual Impairment6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Dry Eye(s)2
- Halo2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A surgeon reported that following an intraocular lens (IOL) implant procedure, the patient experienced an inflammatory reaction approximately one week after implantation, with inability of the iris to dilate normally, accompanied by photophobia and discomfort when transitioning from light to dark environments and vice versa. The reaction was diagnosed by the treating physician as iritis and was managed with anti-inflammatory treatment. The surgeon suspected a potential issue related to the lens material and requested further investigation.Additional information has been requested and received stating that that anti-inflammatory treatment, including a fluoroquinolone antibiotic plus corticosteroid, a non-steroidal anti-inflammatory drug, and a corticosteroid (glucocorticoid). No explantation procedure was performed. The patient had not returned for a follow-up visit, as the patient chose to continue care with another healthcare professional. No information was available regarding the patient¿s current condition.
Patient problems: Eye Injury; Eye Irritation; Uveitis; Visual Disturbances
MAUDE report 50932707 ↗InjurySep 11, 2026No Apparent Adverse Event
Patient problems: Visual Disturbances
MAUDE report 50737221 ↗MalfunctionMay 6, 2026Break; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED A PLANNED EXPLANT WITH PATIENT REASON AS SUBLUXATION OF LENS, HAPTICS BROKE AND CLINICAL REASON FOR EXPLANT BEING LENS MOVED OFF CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXPLANTED AND REPLACED WITH A NEW LENS IN A SECONDARY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25093914 ↗MalfunctionMar 16, 2026Break
A PHYSICIAN REPORTED THAT DURING A PHAKIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS OPENED ON THE TABLE, FOLDED IN THE CARTRIDGE, AND BEFORE IT WAS PLACED INTO THE EYE, IT WAS OBSERVED THAT THE HAPTIC WAS BROKEN. ANOTHER UNSPECIFIED LENS WAS IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605361 ↗MalfunctionFeb 18, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NOTICED PERSISTENT LINE IN VISION. THE SURGEON OBSERVED A SMALL SCRATCH ON THE OPTIC OF THE LENS AND PLANNING TO EXPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 24376376 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 28 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24310679 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS EXCHANGED WITH ANOTHER COMPANY MONOFOCAL LENS DURING THE SECONDARY PROCEDURE.
Patient problems: Visual Impairment
MAUDE report 23479188 ↗MalfunctionApr 17, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS FILE IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 21855732 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED BLURRED VISION (20/70) AND HAD A YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE. THE PATIENT FELT THAT HER VISION WAS BETTER PRIOR TO HAVING THE COMPANY LENS IMPLANTED AND WAS ADVISED TO SPEAK TO THE SURGEON ABOUT THE ISSUES SHE IS EXPERIENCING OR SEEK A SECOND OPINION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 21855600 ↗MalfunctionFeb 19, 2025Break; Break
A HEALTHCARE PROFESSIONAL HAD REPORTED THAT DURING PHAKIC SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A FRACTURE WAS OBSERVED AT THE CORNER OF THE LENS HAPTIC, AND THE POSITION OF THE HAPTIC WAS NOTED TO BE FOLDED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH UNSPECIFIED REPLACEMENT LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411966 ↗MalfunctionJan 10, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS WAS BROKEN. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS.
Patient problems: Insufficient Information
MAUDE report 21122545 ↗MalfunctionNov 13, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL INDENTATION/MARK ON IOL. THEY DISCUSSED POTENTIALLY LOADING TECHNIQUE ISSUES AND INJECTORS NOT BEING USED CORRECTLY AND CAREFULLY BY NURSING STAFF. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT WAS UNAFFECTED AND LENS WAS STILL IN THE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675171 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS EXPLANTED AND IMPLANTED WITH NON-COMPANY LENS. THERE WAS NO COMPLICATIONS AND SYMPTOMS WERE RESOLVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Diplopia/Double Vision; Dry Eye(s); Halo; Nausea; Photophobia; Red Eye(s); Visual Disturbances; Visual Impairment
MAUDE report 20638306 ↗InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING AS PER SURGEON'S OPINION NOT PRODUCT RELATED PROBLEM, THE PATIENT WAS NOT HAPPY ABOUT HAVING HALOS AROUND LIGHTS. THE IOL WAS EXCHANGED FOR NON COMPANY LENS 21.5 DIOPTER MODEL 1 MONTHS 25 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE WITH NO PATIENT HARM.
Patient problems: Blurred Vision; Dry Eye(s); Halo; Visual Disturbances; Visual Impairment
MAUDE report 20310689 ↗MalfunctionAug 21, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT UNFOLDED IN THE EYE WITH ¿VERY SIGNIFICANT¿ MARKS ON THE OPTICS. ¿LENS REMAINS IMPLANTED IN THE PATIENTS EYE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20010961 ↗InjuryJul 17, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED DAMAGED INTRAOCULAR LENS. THE PROCEDURE WAS COMPLETED AFTER 4 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19760704 ↗InjuryMay 15, 2024Break; Optical Decentration; Device Damaged by Another Device; Scratched Material; Material Split, Cut or Torn; Break; Optical Decentration; Device Damaged by Another Device; Scratched Material; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS DAMAGED (BY THE RETRACTABLE TIP OF THE INJECTOR) AND THE OPTICAL ZONE WAS SCRATCHED AND THE HAPTICS WERE TORN OFF. PATIENT EXPERIENCED DETERIORATION IN VISION AND HAD INCORRECT OPTICAL ZONE. ACCORDING TO CURRENT INFORMATION THE PATIENT IS FINE. AN EXPLANT HAS BEEN PLANNED. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT'S LENS WAS CUT INTO 3 PIECES USING SCISSORS UNDER LOCAL ANESTHESIA, FOLLOWED BY EXPLANTATION OF THE LENS THROUGH THE ORIGINAL WOUND. THAN A COMPANY REPLACEMENT LENS WAS IMPLANTED. POSTOPERATIVELY THERE WAS A SLIGHT ELEVATION OF INTRAOCULAR PRESSURE (IOP) AND EDEMA AT THE SITE OF THE SURGICAL WOUND. THE HOSPITAL IS CURRENTLY FOLLOWING UP WITH THE PATIENT.
Patient problems: Corneal Edema; Intraocular Pressure Increased; Visual Impairment
MAUDE report 19320500 ↗MalfunctionMar 18, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT EJECT FROM CARTRIDGE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921567 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PATIENT NOT HAPPY WITH VISION. THE CLINICAL REASON WAS REPORTED TO BE REFRACTIVE SURPRISE. THE IOL WAS REPLACED WITH UNSPECIFIED LENS WITHIN IN A MONTH FROM INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18569259 ↗MalfunctionJul 3, 2023Crack; Failure to Eject; Crack; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WERE CRACKED WITH PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17246034 ↗InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS RETROACTIVE SURPRISE DUE TO PREVISION LASIK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16992243 ↗InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE AND POOR VISION. THE PATIENT WAS NOT ABLE TO TOLERATE THE GLARE AND POOR VISION HENCE THE LENS WAS EXPLANTED IN A SECONDARY SURGERY. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances
MAUDE report 16863075 ↗InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PERSISTING IRRITATION AND DISCOMFORT FOR TWO MONTHS. THE LENS WAS REPLACED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE LENS WAS REPLACED WITH ANOTHER COMPANY'S LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.
Patient problems: Discomfort
MAUDE report 16542895 ↗InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PROBLEM TO PATIENT AFTER INTRAOCULAR LENS (IOL) REPLACEMENT.
Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions
MAUDE report 16535391 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ONE AFTER 3 WEEKS DUE TO POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT PATIENT WAS COMPLAINING OF WAXY VISION, SO THE IOL WAS REPLACED WITH A MONOFOCAL NON COMPANY IOL. AFTER THE REPLACEMENT, THERE WAS NO COMPLAINT OF WAXY VISION.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16050837 ↗
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.
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