Clareon™ CNWTT3 (UDI 00380652468763)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 00380652468763), received between Apr 6, 2026 and Jul 14, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver1
- Particulates1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2026Particulates
A NON-HEALTHCARE PROFESSIONAL REPORTED AFTER ONE TO TWO WEEKS OF CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SMALL SPOTS AND BLURRED VISION IN BOTH EYES AND WAS HOSPITALIZED. NO INFLAMMATION WAS OBSERVED, AND THE SURGEON SUSPECTED THAT THE CAUSE MAY BE RELATED TO THE LENS OR THE VISCOELASTIC. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED. THE SURGEON REPORTED THAT THE COLD CHAIN WAS PROBABLY NO LONGER IN OPTIMAL CONDITION AND IT WAS NOT POSSIBLE TO DETECT THE PROBLEM BEFORE USING THE PRODUCT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT DELAY. THERE WERE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT, AND THIS REPORT WAS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 25810528 ↗MalfunctionApr 6, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THE PLUNGER WENT OVER THE INTRAOCULAR LENS (IOL) AND DID NOT INJECT IT. THE SURGEON THUS SWITCHED OVER TO A DIFFERENT INJECTOR (COMPANY PROVIDED INJECTOR) AND AN UNSPECIFIED LENS TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791493 ↗
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.