Clareon CNW0T3 (UDI 00380652409605)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652409605), received between May 10, 2023 and Nov 25, 2025 — classified as 1 injury, 4 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
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Scratched Material; Scratched Material
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THERE WAS A SCRATCH OR MARK ON THE OPTIC. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 23641568 ↗MalfunctionNov 18, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED AND FOUND TO BE SCRATCHED. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23579902 ↗MalfunctionNov 11, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR LOOP WAS TORN AFTER IMPLANTATION. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH THE SAME PRODUCT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23521611 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TARGET WAS SIGNIFICANTLY DEVIATED HENCE THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 22187329 ↗MalfunctionMay 10, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT SEATED CORRECTLY IN THE WAGON WHEEL AT THE TIME OF OPENING. THE LENS APPEARED TO BE CRACKED. THE LENS WAS IMPLANTED, INTERNAL CRACK WAS THEN DISCOVERED, AND THE LENS WAS REMOVED FROM THE PATIENT DURING INITIAL PROCEDURE. SURGICAL TECHNICIAN ALSO STATES THAT THE LENS DID NOT REMAIN IN THE LOADED CARTRIDGE LONGER THAN 3 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16901533 ↗
Other intraocular lens devices
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- 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.
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