Clareon CCW0T3 (UDI 00380652431880)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · 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 00380652431880), received between May 4, 2023 and May 8, 2026 — 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
- Defective Device1
- Failure to Deliver1
- Malposition of Device1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS INSERTED AND REMOVED. THE ORIGINALLY SCHEDULED PROCEDURE COMPLETED THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125308 ↗MalfunctionAug 11, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE INJECTOR. THERE WAS PATIENT CONTACT AND SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS INSERTED INSIDE EYE BUT WAS NEVER RELEASED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773108 ↗InjuryNov 21, 2023Malposition of Device; Malposition of Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY. CLINICAL REASON FOR EXPLANTATION IS IOL ROTATED AND UNDER CORRECTION. LENS WAS EXPLANTED DURING SECONDARY PROCEDURE. REPLACED WITH COMPANY LENS.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18184110 ↗MalfunctionAug 8, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT NOTICED SCRATCH ON THE LENS AFTER IMPLANT. THE LENS WAS THEREFORE EXPLANTED FROM THE EYE DURING THE INITIAL PROCEDURE. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS NECESSARY.
Patient problems: Insufficient Information
MAUDE report 17478837 ↗MalfunctionMay 4, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED ABOUT A LENS BEING DAMAGED WHICH NOTICED AFTER LENS INSERTED INTO EYE DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Insufficient Information
MAUDE report 16866925 ↗
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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