Clareon CNWTT0 (UDI 00380652408226)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652408226), received between Oct 23, 2024 and Aug 27, 2026 — classified as 2 injuries, 6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break
A physician reported that before a phakic intraocular lens (IOL) implantation procedure, it was determined that one of the lens haptics had detached from the optic. As a result, the lens could not be implanted. There was no patient harm.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474364 ↗MalfunctionOct 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT LENSES WERE SCRATCHED BY THE INJECTOR. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SCRATCH WAS IDENTIFIED BY THE SURGEON UNDER THE MICROSCOPE DURING LENS INSERTION. THE LENS WAS NOT IMPLANTED BUT REMOVED BEFORE FULL INSERTION. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348788 ↗MalfunctionJul 28, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS WAS IDENTIFIED WITH A FRACTURED HAPTIC IN THE RIGHT EYE. THE DEFECTIVE LENS WAS EXPLANTED AND REPLACED WITH COMPANY LENS DURING THE INITIAL PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NOFURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22628762 ↗InjuryMay 13, 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 BLURRED VISION AND SEVERE DYSPHOTOPSIA. CLINICAL REASON FOR EXPLANT WAS SEVERE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS 04 MONTHS 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22014683 ↗MalfunctionDec 10, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING INTRAOCULAR LENS (IOL) INTO THE INJECTOR, ONE HAPTIC BROKE. A DIFFERENT IOL WAS IMPLANTED TO COMPLETE HE PROCEDURE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20890527 ↗InjuryNov 28, 2024Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE IMPLANTATION OF THE LENS WITH THE STANDARD COMPANY CARTRIDGE INJECTOR RECOMMENDED BY THE MANUFACTURER, THE INTEGRITY OF THE IOL (INTRAOCULAR LENS) WAS COMPROMISED IN THE FORM OF A DETACHMENT OF THE SUPPORTING HAPTIC ELEMENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE DURING IMPLANTATION, WHEN THE I/O LENS EXITED THE CARTRIDGE, A MISSING POSTERIOR HAPTIC WAS DISCOVERED HAPTIC ELEMENT WAS TORN OFF. IOL WAS EXPLANTED AND EXCHANGED FOR A SIMILAR MODEL OF THE SAME DIOPTER LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. THERE IS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805110 ↗MalfunctionNov 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS CAME OUT OF THE CARTRIDGE, THE END PART OF THE IOL OPTICS WAS CRACKED. THE DEFECTIVE IOL WAS NOT IMPLANTED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20739414 ↗MalfunctionOct 23, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, INTRAOCULAR LENS BROKEN WHEN INJECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20515755 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.