Alcon, Ozil, TurboSonics, Mini-Flared ABS 8065751176Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657511761), received between Apr 2, 2021 and Jun 20, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 28, 2023Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT THE ULTRASOUND DID NOT WORK, EVEN THOUGH THE TESTS WERE PASSING DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAIL WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22301454 ↗
• MalfunctionJun 13, 2025Obstruction of Flow; Obstruction of Flow

  A PHARMACIST REPORTED THAT THE ULTRASOUND STOPPED WORKING DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PHACOEMULSIFICATION TIP WITH NEW ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE PHACOEMULSIFICATION TIP INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201740 ↗
• MalfunctionNov 22, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE TIP OF A PRODUCT WAS FOUND BENT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755694 ↗
• MalfunctionJul 3, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED ASPIRATION FAILURE OF THE PHACO TIP OCCURRED DURING ULTRA SOUND OF SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664087 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE SHAPE WAS DEFECTIVE AND A BEVEL WAS MISSING BEFORE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19603743 ↗
• MalfunctionJul 3, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED TIP WAS FOUND TO BE BENT FROM THE BEGINNING DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247873 ↗
• MalfunctionNov 4, 2022Loose or Intermittent Connection; Suction Failure; Loose or Intermittent Connection; Suction Failure

  A PHYSICIAN REPORTED A US (ULTRASOUND) OSCILLATION FAILURE OCCURRED DUE TO LOOSENING DESPITE TIGHTENING US TIP DURING A SURGERY. THE SURGERY TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727017 ↗
• MalfunctionOct 6, 2022Loose or Intermittent Connection; Suction Failure; Loose or Intermittent Connection; Suction Failure

  A PHYSICIAN REPORTED TIP BECAME LOOSE, AND ULTRASOUND (US) OSCILLATION WAS UNABLE TO BE PERFORMED DURING ULTRASOUND PHASE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551389 ↗
• MalfunctionMay 27, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION WAS POOR DURING ULTRASOUND PHASE OF A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521845 ↗
• MalfunctionMay 7, 2022Particulates; Particulates

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY METALLIC POWDER-LIKE SUBSTANCE WAS LEFT ON THE IRIS DURING SURGERY. SURGEON SUSPECT FOREIGN OBJECT WAS FROM THE PHACOEMULSIFICATION HANDPIECE, PHACO TIP, SLEEVE, OR PACK. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE FOREIGN MATERIAL AND THE PATIENT IS SCHEDULED FOR OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318016 ↗
• MalfunctionApr 16, 2021Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE ULTRASOUND TIP WAS CLOGGED AND ASPIRATION FAILURE OCCURRED. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682177 ↗
• MalfunctionApr 2, 2021Appropriate Device Problem Term/Code Not Available; Suction Failure; Appropriate Device Problem Term/Code Not Available; Suction Failure

  A SURGEON REPORTED WHEN USING THE HANDPIECE DURING THE ULTRASOUND PHASE OF A CATARACT PROCEDURE, THE OSCILLATION AND ASPIRATION STOPPED ACTUATING. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER REPLACING THE ULTRASOUND TIP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609381 ↗