Clareon CNW0T4 (UDI 00380652410168)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652410168), received between Sep 28, 2021 and Aug 10, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
- Material Split, Cut or Torn1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Blurred Vision1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
A healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced decreased visual acuity. Hence the lens was explanted and replaced with a non-company lens in a secondary procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision
MAUDE report 50193912 ↗MalfunctionJun 5, 2026Break
A NON HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS HAD DETACHED FROM THE LENS, NECESSITATING THAT IT BE CUT AND REMOVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410007 ↗MalfunctionDec 12, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, AN ATTEMPT WAS MADE TO IMPLANT THE LENS, BUT IT WAS DEFECTIVE / TORN. THERE WAS NO HARM TO THE PATIENT, AND A BACKUP UNIT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790729 ↗MalfunctionNov 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRACKED AFTER INSERTION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH COMPANY ANOTHER LENS. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809231 ↗MalfunctionSep 28, 2021Crack; Crack
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL OPTIC GOT CRACKED FROM THE HAPTIC ROOT TO THE CENTER. THE SURGERY WAS COMPLETED AND THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12538740 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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