Clareon CNW0T5 (UDI 00380652410588)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
- 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 00380652410588), received between Apr 1, 2026 and Apr 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS ROTATED TO 30 OR 40 DEGREE ON POST OPERATIVE DAY 1. THE LENSES WAS IMPLANTED ON HIGH MYOPE PATIENTS WITH VERTICAL LENS PLACEMENT. IN 2 OF 3 CASES A CAPSULAR TENSION RING WAS USED DURING THE SURGERY TO REDUCE THE ROTATION OF THE LENS IN THESE PATIENTS HOWEVER, THE LENS WAS ROTATED IN ONE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24839413 ↗MalfunctionApr 1, 2026Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS ROTATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 24751672 ↗
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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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