Alcon, TurboSonics, ABS, MicroTip 8065790020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657900206), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Suction Failure” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2410-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT NO ASPIRATION WAS APPLIED AT ALL DURING ULTRASOUND (US) AND IRRIGATION ASPIRATION (IA) PHASE OF CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE PAK AND TIP WAS REPLACED, BUT DID NOT IMPROVE THE PROBLEM, SO ASPIRATION WAS PERFORMED MANUALLY BY OTHER COMPANY NEEDLE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681999 ↗