Clareon CNW0T5 (UDI 00380652410656)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 00380652410656), received between Mar 7, 2023 and Apr 16, 2026 — classified as 1 injury, 3 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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Advance1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Scratched Material
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS SCRATCHED AFTER IMPLANTING IT. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24895837 ↗InjuryAug 8, 2025Adverse 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) IMPLANTATION PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE RESULT. THE IOL WAS REPLACED WITH A NON-COMPANY MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON PROVIDED WAS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 22748562 ↗MalfunctionJun 4, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME STUCK IN THE DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22143452 ↗MalfunctionMar 7, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND DAMAGED IN THE PATIENT'S EYE AFTER IMPLANTED THE LENS. THERE WAS A CROSS-SHAPED SCRATCH IN THE LOWER PART OF THE OPTIC AROUND THE HAPTIC. AFTER THE LENS WAS EXPLANTED USING THE IOL CUTTER IN THE EYE, A BACK-UP LENS OF THE SAME POWER WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO IMPACT ON PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16493921 ↗
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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
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- 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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