Clareon CCW0T4 (UDI 00380652432917)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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652432917), received between Aug 11, 2023 and May 28, 2026 — classified as 2 injuries, 2 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
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material2
- Break1
Patient problems
- Insufficient Information2
- Blurred Vision1
- Fibrosis1
- Posterior Capsule Opacification1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Break; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AT THE TIME OF DELIVERY, MULTIPLE PERIPHERAL SCRATCHES AND SEVERED TRAILING HAPTIC. THE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH COMPANY LENS DURING INITIAL IMPLANTATION PROCEDURE AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25314854 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EARLY POSTERIOR CAPSULE OPACIFICATION (PCO). PATIENT WAS 3 WEEKS POST-OP WITH ANTERIOR AND POSTERIOR CAPSULE OPAQUE WITH PIN HOLE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT WAS 3 WEEKS POST-OP WITH ANTERIOR AND POSTERIOR CAPSULE CONTRACTED AND OPAQUE WITH PIN HOLE VISION. PATIENT ISSUES WERE NOT RESOLVED, SCHEDULED FOR YAG CAPSULOTOMY ANTERIOR AND POSTERIOR.
Patient problems: Fibrosis; Posterior Capsule Opacification; Visual Impairment
MAUDE report 22158794 ↗InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER SURGEON OPINION IOL CAUSED THE PATIENT HARM POOR QUALITY OF VISION. THE IOL WAS EXCHANGED FROM TORIC 22.0 DIOPTER COMPANY LENS TO TORIC SAME MODEL 18.0 DIOPTER COMPANY LENS 2 MONTHS 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. PATIENT ISSUES WERE RESOLVED, AND THE SURGEON PROGNOSIS WAS EXCELLENT.
Patient problems: Blurred Vision
MAUDE report 21191325 ↗MalfunctionAug 11, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A SCRATCH ON THE LENS AFTER IMPLANTATION, THE LENS WAS THEREFORE EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17511070 ↗
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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