Clareon CNWTT0 (UDI 00380652408110)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 Alcon Clareon intraocular lens is an implant placed in the eye to replace the natural lens. The 23 reports describe blurred or poor vision that often led to removal and replacement of the lens, and lenses damaged, scratched or torn during implantation. There were no deaths and 15 injuries mentioned, and 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
- 23
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652408110), received between Aug 19, 2022 and Jul 14, 2026 — classified as 15 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 Problem13
- Break2
- Material Split, Cut or Torn2
- Scratched Material2
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Material Opacification1
Patient problems
- Blurred Vision9
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions4
- Visual Impairment4
- Visual Disturbances2
- Corneal Decompensation1
- Dizziness1
- Keratitis1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DAMAGED BY THE INJECTOR, FOLDING PROCESS, OR CARTRIDGE DURING IMPLANTATION. THE IOL WAS IMPLANTED INTO THE PATIENT'S EYE; HOWEVER, THE DAMAGE WAS IDENTIFIED AND THE LENS WAS SUBSEQUENTLY EXPLANTED DURING THE SAME, PROCEDURE. A BACKUP REPLACEMENT LENS WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO HOSPITALIZATION WAS REQUIRED, NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY BEYOND THE LENS EXCHANGE, AND WITH NO PATIENT HARM. THREE MEDICAL DEVICE REPORTS WERE ASSOCIATED WITH THIS COMPLAINT, AND THIS REPORT WAS 3 OF 3. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821611 ↗InjuryApr 30, 2026Material Opacification; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING THE INITIAL INTRAOCULAR SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. AS A RESULT, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH AN MONOFOCAL LENS 7 MONTHS, 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS HAZY OPTICS ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 25045943 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS EXCHANGE DUE TO PATIENT'S VISION DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24311336 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER NONCOMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL BREAKDOWN. THE PATIENT'S ISSUE RESOLVED, AND THE SURGEON PROGNOSIS WAS GOOD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24068380 ↗InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT'S REFRACTION DID NOT MATCH. THE IMPLANTED LENS WAS EXCHANGED WITH UNSPECIFIED IOL OF DIFFERENT TORIC POWER AND DIOPTER VALUE.
Patient problems: Visual Impairment
MAUDE report 23908490 ↗MalfunctionSep 19, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS TORN OR BROKEN AND NOT PROPERLY ATTACHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23094500 ↗MalfunctionAug 12, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC HAD A CUT UPON INSERTING INSIDE THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO FURTHER MEDICAL INTERVENTION WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780812 ↗InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT RECEIVED VISUAL ACUITY OF 0.2 WITHOUT CORRECTION. WITH A CYLINDER CORRECTION OF 2.0 D, THE PATIENT RECEIVES VISUAL ACUITY OF 0.7. THE SURGEON CLAIMS THAT THE CALCULATIONS WERE MADE CORRECTLY, THE LENS WAS POSITIONED PRECISELY IN THE CAPSULE OF THE POSTERIOR SAC, HAS NO TILT. THEREFORE, IN HIS OPINION, THE OBTAINED RESULT WAS ASSOCIATED WITH THE LENS. ADDITIONAL INFORMATION REQUESTED, RECEIVED AND STATED THE PATIENT CONTINUED TO COMPLAIN OF LOW VISUAL ACUITY. INITIAL UNCORRECTED VISUAL ACUITY WAS 0.2, IMPROVING TO 0.7 WITH CYLINDER CORRECTION OF +2.0 D. ON (B)(6) 2025, THE SAME LENS WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. AROUND THIS TIME, THE PATIENT REPORTED DISSATISFACTION WITH THE VISION IN THE LEFT EYE. EXAMINATION REVEALED A MODERATE, DECOMPENSATED CONDITION OF THE ANTERIOR CORNEAL EPITHELIUM, WHICH WAS TREATED WITH TEAR SUBSTITUTES. FOLLOW-UP ASSESSMENTS ON (B)(6) 2025, SHOWED RESOLUTION OF THE CORNEAL CONDITION AND IMPROVED VISUAL ACUITY (CORRECTED TO 7 LINES). HOWEVER, NON-CORNEAL ASTIGMATISM WAS NOTED.
Patient problems: Corneal Decompensation; Keratitis; Visual Impairment
MAUDE report 22052500 ↗MalfunctionApr 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS OPTIC WAS BROKEN AND THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 21917516 ↗InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IT WAS DIFFICULT TO CONFIRM ABOUT THE REPLACEMENT LENS. THE DIRECTOR MENTIONED THE PATIENT'S SENSITIVITY AND MALADAPTATION RATHER THAN DIRECTLY MENTIONING THE LENS REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 21273648 ↗InjuryJan 6, 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 LENS WAS EXPLANTED WITH REASON UNKNOWN ISSUE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 04 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21078322 ↗MalfunctionOct 24, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT, SCRATCH ON IOL WAS NOT VISUALLY SIGNIFICANT. IT WAS LOCATED IN THE CENTER. NO ADVERSE DEVICE EFFECTS NOTATED AT THIS TIME. SCRATCH WAS SEEN AT VISIT 1A AND 2A BUT WAS TOO SOON TO DETERMINE FOR CERTAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT ISSUE WAS NOTICED ON POD#1I.E., (B)(6) 2024. THE ISSUE WITH THE LENS WAS NOT NOTICED UNTIL THE ONE-DAY POST-OP VISIT - THIS WAS NOT NOTATED OR NOTICED IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 20521480 ↗MalfunctionOct 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK OCCURRED AFTER INSERTION OF THE IOL. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20426657 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT WAS UNABLE TO READ AND DRIVE. THE LENS EXCHANGE WITH COMPANY LENS OF DIFFERENT MODEL. THE SYMPTOMS WERE RESOLVED AFTER LENS EXCHANGE AND THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 20267170 ↗InjurySep 10, 2024Optical Decentration; Optical Decentration
ADDITIONAL INFORMATION RECEIVED STATING THAT, THE IOL WAS IMPLANTED IN THE EYE.
Patient problems: Blurred Vision
MAUDE report 20178527 ↗InjuryFeb 16, 2024Adverse 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 HAZY VISION AT NEAR/INTERMEDIATE DISTANCE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT UNSATISFIED WITH HAZY VISION AT NEAR AND INTERMEDIATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18720926 ↗InjuryNov 28, 2023Adverse 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 HAD POOR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PSEUDOPHAKIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18216826 ↗MalfunctionJul 17, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH ON LENS, LENS HAD TO BE CUT TO REMOVE FROM PATIENT WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333285 ↗InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FELT VERY UNCOMFORTABLE WITH STRONG LIGHT REFLECTION AND BLURRED VISION. NUMEROUS STREAKS OF LIGHT FROM STREET LAMPS AT NIGHT COVERED THE ENTIRE FIELD OF VISION OF THE LEFT EYE, AND ONLY THE STREAKS OF LIGHT ARE VISIBLE IN THE LEFT EYE. THE IOL WAS SWITCHED WITH UNSPECIFIED LENS. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 17214270 ↗InjuryJun 22, 2023Adverse 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 BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATELY FOUR MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS BLURRED VISION 20/70 DISTANCE J16 NEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17182667 ↗InjuryMay 25, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THREE MONTHS AFTER SURGERY, UNCORRECTED VISUAL ACUITY HAD DECREASED TO FROM 0.6 TO 0.3. THE PHYSICIAN NOTED A LENS DEFECT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17001690 ↗MalfunctionOct 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, DEEMED NOT IMPLANTABLE DUE TO SURGEON NOTICED A BLACK SMUDGE ON THE LENS AFTER IMPLANTATION. THE ISSUE WAS NOTED AFTER THE LENS WAS IMPLANTED. THE LENS WAS CUT OUT AND A NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15603111 ↗InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT COMPLAINED ABOUT SEEING TWO IMAGES OF A SINGLE OBJECT SO THAT FELT DIZZY. THE LENS WAS REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Dizziness; Visual Disturbances
MAUDE report 15257083 ↗
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