Alcon, TurboSonics, MicroTip 30KTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657403042), received between Nov 7, 2021 and Nov 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 7, 2021Break; Suction Failure; Break; Suction Failure

  A PHYSICIAN REPORTED THE CATARACT MATERIALS WERE NOT EMULSIFYING AND THE FRAGMENTS WERE NOT GETTING ASPIRATED DURING A CATARACT PROCEDURE. WHEN THE SURGEON CHECKED IT, HE FOUND THE PHACOEMULSIFICATION (PHACO) TIP HAD AN UNEVEN SHAPE AND IT WAS CRACKED AT THE BENT AREA. ANOTHER PHACO TIP WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763853 ↗