Clareon™ CNWTT3 (UDI 00380652468251)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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652468251), received between Oct 14, 2022 and Jun 15, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Conjunctivitis1
- Endophthalmitis1
- Eye Pain1
- Fibrosis1
- Hypopyon1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER POSTOPERATIVE DAY 14 OF CATARACT SURGERY WITH OPHTHALMIC HANDPIECE, INTRAOCULAR LENS, PHACO TIP, VISCOELASTIC DEVICE, CONSUMABLE , A 68 YEARS OLD FEMALE PATIENT EXPERIENCED WITH ENDOPHTHALMITIS IN LEFT EYE WITH SYMPTOMS OF EYE PAIN, BLURRY VISION, FLOATER, CONJUNCTIVAL INFLAMMATION WAS <1+, AQUEOUS CELL WAS 3+, AQUEOUS FIBRIN WAS PRESENT WITH HYPOPYON. PATIENT WAS TREATED WITH INTRAVITREAL TAP AND ANTIBIOTICS, CORTICOSTEROIDS MEDICATIONS. CULTURE RESULTS REVEALED NO BACTERIAL GROWTH. CURRENT PATIENT CONDITION WAS UNKNOWN. THIS IS THE REPORT OF PATIENT 3 OF 4.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Conjunctivitis; Endophthalmitis; Eye Pain; Fibrosis; Hypopyon; Red Eye(s); Vitreous Floaters
MAUDE report 17133629 ↗MalfunctionOct 14, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOUND TO BE A SCRATCH ON OPTIC OF THE IOL. THE PHYSICIAN REMOVED THE IOL FROM PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15606065 ↗
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.