Clareon CNW0T4 (UDI 00380652410205)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652410205), received between May 31, 2023 and May 8, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Corneal Edema1
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN THE IOL WAS BEING INSERTED, OPTICAL DAMAGE OCCURRED AND THE LENS WAS SCRATCHED WITHIN THE DELIVERY SYSTEM WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25124675 ↗MalfunctionNov 4, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; AFTER IMPLANTING THE LENS, SURGEON LOOKS UNDER THE MICROSCOPE THAT THE LENS IS MARKED ON ITS PERIPHERY CAUSED BY THE INJECTOR. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463882 ↗MalfunctionJul 22, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEFORE PLACING IT IN THE PATIENT'S EYE SURGEON NOTICED THAT ONE OF THE HAPTICS HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING ANOTHER UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22567067 ↗MalfunctionMar 28, 2025Break; Break
A PHYSICIAN REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LOADING TRAILING HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21717854 ↗InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR IMPLANTATION PROCEDURE (IOL),PATIENT HAD POSTOPERATIVE INFLAMMATION, CELLS WERE FOUND AND DESCEMET'S MEMBRANE WRINKLED. CORTICOSTERIODS DROPS WAS INSTILLED FREQUENTLY AND FORTUNATELY THE SYMPTOMS HAVE SUBSIDED. THERE ARE 8 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 8 OF 8.
Patient problems: Corneal Edema; Inflammation
MAUDE report 18407877 ↗MalfunctionMay 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS HAD A TEAR. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029101 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page