Clareon CNW0T5 (UDI 00380652410724)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
- 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 00380652410724), received between Jul 1, 2022 and Aug 22, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Device Contamination with Chemical or Other Material1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER ON COMPANY CARTRIDGE WENT OVER LENS AND SCRATCHED IT. THERE WAS NO PATIENT CONTACT TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEON'S OPINION, ISSUE OR DEFECT WITH CARTRIDGE CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877219 ↗MalfunctionApr 5, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), A CRACK WAS OBSERVED AT THE OPTICAL PART OF THE IOL AFTER INSERTION OF THE IOL, SO THE INSERTION WAS STOPPED AND THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM. THE PHYSICIAN RECOGNIZED THAT THERE WAS NO PROBLEM WITH THE REPLACEMENT AND NO HEALTH HAZARD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16685629 ↗MalfunctionJul 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED AFTER AN IOL WAS IMPLANTED, TWO LINE-LIKE FOREIGN MATERIALS WERE FOUND ON THE BACK OF THE IOL. WHEN ASPIRATED THEM BY IRRIGATION AND ASPIRATION (IA), ONE WAS REMOVED, BUT THE OTHER WAS NOT. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE PATIENT AFTER SURGERY HAD NO PROBLEMS, INCLUDING THE VA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THE TWO LINE COULD ALSO BE REFERRED TO SCRATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14885131 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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