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Alcon 8065750123Recalls & reported problems

Alcon Laboratories, Inc. · Biometry Probe 10MHZ · Class 2

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 00380657501236), received between Oct 10, 2022 and Oct 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Data Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Data Problem1

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.

  • MalfunctionOct 10, 2022Appropriate Device Problem Term/Code Not Available; Data Problem; Appropriate Device Problem Term/Code Not Available; Data Problem

    A CUSTOMER REPORTED THAT A BIOMETRIC PROBE MARKED INAPPROPRIATE RESULTS. THE PROBE HAS A RED BULB IN THE CENTRAL PART THAT DID NOT TURN ON. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SENSOR HAD PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15569130 ↗

Other System, imaging, pulsed echo, ultrasonic devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.