Alcon, Kelman, TurboSonics, ABS 8065752065Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657520657), received between Jan 17, 2023 and Jul 9, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 25758887 ↗
• MalfunctionDec 25, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE CENTRAL PORTION OF THE TIP WAS CURVED AND CAN BE SEEN EVEN IF IT WAS NOT OPEN BEFORE SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23892327 ↗
• MalfunctionDec 5, 2025Obstruction of Flow; Incomplete or Inadequate Connection; Obstruction of Flow; Incomplete or Inadequate Connection

  A PHYSICIAN REPORTED THAT THERE WAS NO ULTRASOUND DURING ULTRASOUND MODE OF CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP.

  Patient problems: Insufficient Information

  MAUDE report 23725346 ↗
• MalfunctionJun 16, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ASPIRATION STOPPED WORKING IN THE MIDDLE OF THE PROCESS DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. 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 22212933 ↗
• MalfunctionJun 6, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PHACOEMULSIFICATION (PHACO) TIP WAS BENT DURING THE CALIBRATION STEP OF SURGERY. THE SURGERY AND PATIENT DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY WAS COMPLETED BY REPLACING THE NEW PACK FOR THE BALANCED TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157613 ↗
• MalfunctionNov 2, 2023Material Twisted/Bent; Material Twisted/Bent

  THE PHYSICIAN REPORTED THAT SHAFT WAS FOUND BENT BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054500 ↗
• MalfunctionJun 21, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE SYSTEM MESSAGE THAT GAS PRESSURE WAS HIGH WAS DISPLAYED AND THE ULTRASOUND TIP WAS BENT DURING CALIBRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169425 ↗
• MalfunctionMar 16, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE ULTRASOUND TIP WAS FOUND DEFORMED FROM THE ROOT WHEN OPENED. THE PROCEDURE TYPE AND PATIENT HARM DETAILS WAS NOT REPORTED. THE PROCEDURE WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559703 ↗
• MalfunctionJan 17, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A PHYSICIAN REPORTED THIS REPORT OF TIP CAME LOOSE AND COULD NOT BE USED WHILE USING THE ULTRASONIC HANDPIECE. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN, WITH NO REPORT OF A PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16181143 ↗