Clareon CNW0T5 (UDI 00380652402385)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652402385), received between Jul 22, 2022 and May 26, 2025 — classified as 1 injury, 3 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. 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
- Break1
- Defective Device1
- Failure to Eject1
- Malposition of Device1
- Scratched Material1
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE CENTER PART OF THE LENS WAS FOUND DURING INSERTION; IT IS UNKNOWN WHEN THE DEFECT OCCURRED DURING OR AFTER INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22084599 ↗MalfunctionNov 17, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK TO THE TOP OF THE CARTRIDGE AND IT WAS IMPOSSIBLE TO REPLACE IN CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 18160999 ↗InjuryNov 9, 2022Break; Malposition of Device; Break; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO HAVE MISALIGNMENT OF THE AXIS. IOL WAS EXCHANGED DUE TO MISALIGNMENT OF THE AXIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE, HAPTIC IN THE POSTERIOR WAS BROKEN AND WAS INSERTED. CENTERING WAS NOT BAD, SO THE SURGERY WAS COMPLETED AS IS. A FEW DAYS LATER, THE IOL WAS RE-OPERATED FOR DEVIATION AND THE IOL WAS CUT AND REMOVED. POSTOPERATIVE RESULTS WERE NOT FAVORABLE, BUT WERE DEEMED ACCEPTABLE.
Patient problems: Insufficient Information
MAUDE report 15765775 ↗MalfunctionJul 22, 2022Defective Device; Defective Device
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE EDGE OF IOL WAS FOUND TO BE DEFORMED AFTER IMPLANTING. ALTHOUGH HE/SHE THOUGHT THAT IT WAS DAMAGED BY THE IMPLANTING PROCESS, IT TURNED OUT THAT IT WAS ALREADY DEFORMED WHEN TAKING IT OUT OF THE CASE WHEN CHECKED THROUGH SURGICAL VIDEO AFTER THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE PRODUCT WAS NOT REPLACED SINCE IT WAS A SLIGHT DEFORMATION AND IT WAS CONSIDERED THAT THERE WOULD BE NO DAMAGE TO THE PATIENT'S HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15081519 ↗
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.
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