Clareon CNW0T4 (UDI 00380652410106)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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652410106), received between May 10, 2024 and Apr 24, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Product Quality Problem” (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
- Adverse Event Without Identified Device or Use Problem3
- Product Quality Problem1
Patient problems
- Visual Impairment2
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. CLINICAL REASON BEING MENTIONED AS RESIDUAL REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24981848 ↗InjuryMay 2, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE WRONG INTRAOCULAR LENS WAS IMPLANTED. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE AND REPLACED WITH COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21950859 ↗InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NO IMPROVEMENT IN VISION. CLINICAL REASON EXPLANT IS OVERCORRECTION OF ASTIGMATISM. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 2 MONTHS 3 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.
Patient problems: Visual Impairment
MAUDE report 19286443 ↗
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- 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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