Clareon CNW0T4 (UDI 00380652410175)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 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 00380652410175), received between Mar 21, 2023 and May 7, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Defective Component1
- Failure to Deliver1
- Malposition of Device1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC FOUND BROKEN AFTER IMPLANTED TO PATIENT EYE, THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE PATIENT WAS LEFT APHAKIC AND NEW LENS WAS IMPLANTED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25112386 ↗MalfunctionJan 12, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOT IMPLANTED DUE TO MISFIRE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, DOCTOR JUST STARTED LOADING THE LENS HIMSELF AND IF HE FEELS THAT HE DID SOMETHING WRONG AND THERE WAS THE POSSIBILITY OF THE LENS BEING SCRATCHED HE REQUESTS ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 24037554 ↗MalfunctionMay 13, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN IOL BEING INSERTED INTO PATIENT EYE NOTICED HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND INFORMATION WAS NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22008678 ↗MalfunctionJan 15, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH COMPANY ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21157025 ↗InjuryMar 21, 2023Defective Component; Malposition of Device; Defective Component; Malposition of Device
ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON AND STATED THAT, SURGEON REPLIED STATING THEY WENT BACK TO OPERATION ROOM TO ROTATE LENS, BUT WAS NOT SUCCESSFUL DUE TO ONE OF THE HAPTICS WAS VERY ADHERENT TO THE CAPSULAR BAG.
Patient problems: Insufficient Information
MAUDE report 16580613 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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