Clareon CNW0T4 (UDI 00380652410250)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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652410250), received between Dec 10, 2024 and Mar 23, 2026 — classified as 2 malfunctions.
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
- Product Quality Problem1
- Scratched Material1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE IMPLANTATION OF THE IOL (INTRAOCULAR LENS), WHILE IMPLANTING, IT WAS OBSERVED THAT THE OPTIC-HAPTIC POSITIONING MARKS WERE DECENTERED. SURGERY WAS COMPLETED ON THE SAME DAY AND THE LENS WAS LEFT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT STATES THAT HAD A MISMATCH BETWEEN THE TORICITY MARKINGS AND THE HAPTICS (THEY ARE ALIGNED BY DESIGN). THEY FOLLOWED UP WITH THE PATIENT POSTOPERATIVELY, AND IT APPEARED THAT THE TORICITY WAS EFFECTIVE. TO CONTINUE THE PROCEDURE WITHOUT REMOVING THE LENS, DESPITE THIS VERY SIGNIFICANT MISMATCH BETWEEN THE IOL (INTRAOCULAR LENS) TORICITY MARKING AND THE HAPTICS AND POSTOPERATIVELY THE PATIENT APPEARED TO HAVE THE CORRECT ASTIGMATIC HELP FROM THE TORIC LENS.
Patient problems: Insufficient Information
MAUDE report 24661178 ↗MalfunctionDec 10, 2024Scratched Material; Scratched Material
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE OUTSIDE OF THE OPTIC OF THE IOL UNDER A MICROSCOPE AFTER INSERTION OF THE IOL, IOL WAS STILL REMAINS IN THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT PRODUCT REPLACEMENT AND ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20890521 ↗
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- 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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