Clareon CNW0T3 (UDI 00380652409636)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 00380652409636), received between Nov 5, 2024 and Jul 4, 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
- Break1
- Insufficient Device Problem Information1
- Material Split, Cut or Torn1
- Product Quality Problem1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Capsular Bag Tear1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD AS LENS DIDN'T LOOK RIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25709373 ↗MalfunctionFeb 5, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTING THE LENS, A SCRATCH WAS FOUND ON THE RIGHT EDGE OF IOL OPTICS. THE DOCTOR SAID THAT THERE SEEMED TO BE A BIT MORE RESISTANCE WHEN PUSHING THE IOL AND HE THINKS IT MIGHT BE A BURR OR SOMETHING SIMILAR IN THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24266858 ↗MalfunctionSep 19, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23096051 ↗InjuryMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
HEALTH CARE PROFESSIONAL REPORTED DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THAT THE PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURED AND THE IOL WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Capsular Bag Tear
MAUDE report 21537870 ↗MalfunctionNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK WAS FOUND AT THE OPTIC OF THE IOL AFTER INSERTION. IT WAS NOTICED AFTER IMPLANTATION. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20607669 ↗
Other intraocular lens devices
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- 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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