Clareon CCA0T3 (REF CCA0T3.255)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON UVA TORIC ATME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658458638), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT THE LEADING HAPTIC WAS EXPOSED AND OUT OF THE NOZZLE TIP BEFORE INSERTION. THE ISSUE OCCURRED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. THERE WAS PATIENT CONTACT. ACCORDING TO THE NEW INFORMATION RECEIVED, THE ISSUE OCCURRED INTRAOPERATIVELY DURING THE IMPLANTATION ATTEMPT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE SURGEON WAS UNCERTAIN ABOUT THE CAUSE OF THE ISSUE, SUGGESTING IT COULD BE DUE TO A DEVICE DEFECT OR A PRODUCT-RELATED FACTOR. THERE WAS NO HARM TO THE PATIENT, AND THE SURGEON REPORTED A GOOD PROGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450028 ↗
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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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