Clareon™ CNWTT4 (UDI 00380652469128)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652469128), received between Jun 19, 2023 and Aug 27, 2026 — classified as 2 injuries, 4 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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Malposition of Device1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Insufficient Information3
- Blurred Vision1
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Product Quality Problem
A non-health care professional reported with a description, lens was faulty.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50470616 ↗MalfunctionOct 23, 2025Break; Break
A HEALTHCARE PROFESSIONAL DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE HAPTIC BROKE OFF EASILY DURING INSERTION INTO EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND SURGERY WAS COMPLETED WITH A BACKUP IOL.
Patient problems: Insufficient Information
MAUDE report 23368865 ↗InjuryMay 30, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF IMPLANTATION, THE HAPTIC DID NOT SPRING OUT. THE SURGEON HAD TO MANIPULATE THE HAPTIC OUT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR THE SAME MODEL AND SAME DIOPTER TORIC LENS FROM THE SAME COMPANY 7 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED AS "IOL HAD DISLOCATED FROM INITIAL IMPLANTATION." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE SURGEON'S PROGNOSIS WAS EXCELLENT AND THE PATIENT WAS VERY HAPPY. THE PATIENT'S ISSUE WAS RESOLVED WITH NO HARM.
Patient problems: Blurred Vision
MAUDE report 22112124 ↗MalfunctionFeb 21, 2025Break; Break
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21430653 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 18371055 ↗MalfunctionJun 19, 2023Malposition of Device; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS ROTATED AND CAUSES POOR VISUAL ACUITY IN PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17153137 ↗
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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