Clareon CNWTT0 (UDI 00380652408233)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652408233), received between May 31, 2023 and Apr 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Defective Component1
- Material Split, Cut or Torn1
Patient problems
- Corneal Edema1
- 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.
MalfunctionApr 24, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS MOUNTED ACCORDING TO THE STANDARD TECHNIQUE USING THE COMPANY'S CARTRIDGE AND INJECTOR. HOWEVER, RESISTANCE ENCOUNTERED DURING DELIVERY, RESULTING IN APICAL AMPUTATION OF THE LENS. BECAUSE THE LENS HAD ALREADY ENTERED THE EYE, IT WAS NECESSARY TO CUT AND REMOVE IT DURING THE SAME PROCEDURE. BASED ON ADDITIONAL INFORMATION RECEIVED, THE SURGERY PERFORMED WAS CATARACT PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE INVOLVED PATIENT'S RIGHT EYE. THERE WAS NO PATIENT HARM, AND THE CURRENT PATIENT CONDITION WAS REPORTED TO BE VERY WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982245 ↗MalfunctionMay 31, 2023Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THEY HAD TO REMOVE THE LENS BECAUSE IT WAS TORN AND HAD A BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS TORN IN TWO DIFFERENT PLACES AFTER INTRODUCED INTO THE EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. PATIENT HAS CORNEAL EDEMA FOLLOWING SURGERY BOT NO HARM WAS NOTED TO THE PATIENT.
Patient problems: Corneal Edema
MAUDE report 17029070 ↗
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.