Clareon CNW0T5 (UDI 00380652410519)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 00380652410519), received between Jun 22, 2023 and Feb 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- 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.
MalfunctionFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A SURGEON REPORTED THAT FOLLOWING A FEMTOSECOND-LASER-ASSISTED CATARACT SURGERY (FLACS) AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN A HIGH MYOPE PATIENT, NEXT DAY (24 HOURS) SURGEON FOUND THAT THE IOL TO BE ROTATED BY A GOOD 40 DEGREES AND AT ONE WEEK IT REMAINED SIMILAR. THERE WAS NO HISTORY OF ANY EYE RUBBING OR TRAUMA ON THE DAY OF SURGERY. SURGEON ADVISED AN IOL ROTATION TO THE PATIENT. HOWEVER, THE PATIENT WAS NOT KEEN ON A SECOND INTRAOPERATIVE INTERVENTION AND WAS OK TO WEAR WHATEVER THE FINAL REFRACTION WAS, ALTHOUGH PATIENT WAS NOT HAPPY ABOUT IT. ADDITIONAL INFORMATION HAS BEEN WAS RECEIVED AND STATED THAT PATIENT WAS PLANNED FOR 64 DEGREE PLACEMENT BUT AFTER 24 HOURS OF IOL IMPLANTATION HAD 48 DEGREE ROTATION 2.00 DIOPTER CHANGE IN CYLINDRICAL. TH PATIENT WAS WILLING TO ACCEPT THE GLASSES AND WAS NOT KEEN ON IOL ROTATION.
Patient problems: Insufficient Information
MAUDE report 21421784 ↗MalfunctionJun 22, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH OR FOREIGN MATERIAL ON THE SURFACE OF THE INSERTED INTRAOCULAR LENS AFTER SURGERY, THE SAMPLE WAS NOT AVAILABLE AS LENS REMAINED IN THE PATIENT'S EYE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181549 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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