Clareon CCW0T4 (UDI 00380652432894)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652432894), received between Apr 6, 2023 and Jul 4, 2025 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Scratched Material2
- Failure to Deliver1
Patient problems
- Insufficient Information3
- Eye Pain2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 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 BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 22 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS RESIDUAL REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22402925 ↗MalfunctionJun 20, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS DID NOT FIRE, FAULTY CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22296873 ↗MalfunctionJun 6, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED AS WHEN EXPELLING THE LOADED LENS, THE PLUNGER OF SHOOTER WENT UNDER THE LENS AND SCRATCHED AND CUT THE LENS. LENS DID HAVE PATIENT CONTACT. NEW LENS WAS OBTAINED AND USED WITH NO ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEON¿S OPINION, PLUNGER OF THE SHOOTER CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 22156011 ↗MalfunctionMar 6, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SLIGHT BLEMISH ON RIGHT OPTIC EDGE ONCE IMPLANTED. LENS WAS LEFT IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 5 OF 5.
Patient problems: Insufficient Information
MAUDE report 21534107 ↗InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT SHE WANTED A BLUE LIGHT FILTERING LENS TO BE IMPLANTED IN HER EYE. BUT, A COMPANY REPRESENTATIVE CONVINCED HER DOCTOR THAT A UV ONLY LENS WAS BLUE LIGHT FILTERING LENS AND IT WAS IMPLANTED IN HER EYE. THE CONSUMER STATED SHE HAD TIRED EYE AFTER WORKING ON COMPUTER.
Patient problems: Eye Pain
MAUDE report 17875585 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT SHE WANTED A BLUE LIGHT FILTERING LENS TO BE IMPLANTED IN HER EYE. BUT, A COMPANY REPRESENTATIVE CONVINCED HER DOCTOR THAT A UV ONLY LENS WAS BLUE LIGHT FILTERING LENS AND IT WAS IMPLANTED IN HER EYE. THE CONSUMER STATED SHE HAD TIRED EYE AFTER WORKING ON COMPUTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Pain
MAUDE report 16687807 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page