Clareon™ CNWTT3 (UDI 00380652468411)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652468411), received between Jul 3, 2022 and Oct 8, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Crack1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 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 WAS UNABLE TO ADAPT TO DAILY LIFE DUE TO REFRACTIVE ERROR, AND A COMPLAINT HAS BEEN REPORTED DUE TO MALADAPTATION. THE IOL WAS EXCHANGED FOR A NON-COMPANY LENS.
Patient problems: Visual Impairment
MAUDE report 20394486 ↗InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE PUBLISHED ABOUT A 71-YEAR-OLD WOMAN WAS REFERRED TO HOSPITAL FOR CATARACT SURGERY ON HER RIGHT EYE. AFTER 5 MONTHS OF SURGERY POSTOPERATIVELY, HER VISUAL ACUITY WAS DECREASED CONTINUOUSLY. THE PATIENT REQUESTED A LENS REPLACEMENT AFTER CONSULTATION AND A NON-COMPANY LENS REPLACEMENT WAS PERFORMED. SINCE ADHESION OF THE CAPSULE WAS OBSERVED DURING THE REPLACEMENT SURGERY, THE NON-COMPANY LENS WAS FIXED IN-OUT AND THE PROCEDURE WAS COMPLETED. AFTER THE LENS REPLACEMENT WITH NON-COMPANY LENS, THE POWER WAS FIXED. ADDITIONAL INFORMATION WAS RECEIVED, A CAPSULE TENSION RING WAS INSERTED AND THE HAPTICS WERE FIXED OUT OF THE CAPSULE (IN - OUT FIXATION). LITERATURE CITATION: ICHIKAWA K ET.AL., REPORT ON A CASE OF LENS REPLACEMENT FROM MULTIFOCAL INTRAOCULAR LENS TO LIGHT ADJUSTABLE LENS, 2920_JSCRS_O2-7.
Patient problems: Blurred Vision
MAUDE report 19794830 ↗MalfunctionJul 3, 2022Crack; Crack
THE PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CRACK IN THE CENTER OF THE OPTICAL PART AFTER IMPLANTING THE IOL. THERE WAS NO RESISTANCE OR DISCOMFORT AT THE TIME OF IMPLANTATION AND IT WAS FOUND TO BE DAMAGED IMMEDIATELY AFTER IMPLANTING. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE LENS REMAINED IMPLANTED IN THE PATIENT'S EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14898865 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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