Clareon CNW0T5 (UDI 00380652410571)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652410571), received between Mar 14, 2024 and Aug 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Defective Device1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FIRST COMPANY LENS WAS INSERTED AN THE HAPTIC WAS TORN. IT WAS THEN REMOVED FROM THE EYE. A BACKUP LENS OF SAME DIOPTER AND MODEL WAS INSERTED, AGAIN THE HAPTIC WAS TORN AN THE BACKUP LENS WAS REMOVED FROM THE EYE. ANOTHER COMPANY LENS WAS USED AND COMPLETED THE PROCEDURE. IT WAS ALL WITHIN THE SAME PROCEDURE, ASTIGMATISM COULD NOT BE CORRECTED WITH THE INSERTED LENS OTHERWISE THERE WOULD BE NO IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22922523 ↗MalfunctionAug 29, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FIRST COMPANY LENS WAS INSERTED AN THE HAPTIC WAS TORN. IT WAS THEN REMOVED FROM THE EYE. A BACKUP LENS OF SAME DIOPTER AND MODEL WAS INSERTED, AGAIN THE HAPTIC WAS TORN AN THE BACKUP LENS WAS REMOVED FROM THE EYE. ANOTHER COMPANY LENS WAS USED AND COMPLETED THE PROCEDURE. IT WAS ALL WITHIN THE SAME PROCEDURE; ASTIGMATISM COULD NOT BE CORRECTED WITH THE INSERTED LENS OTHERWISE THERE WOULD BE NO IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22922520 ↗MalfunctionMar 14, 2024Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18904228 ↗
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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