Alcon, TurboSonics, Flared ABS, MicroTip 8065740837Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380657408375), received between May 30, 2022 and Feb 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT PHACOEMULSIFICATION TIP SHAPE WAS BENT BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED BUT IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343217 ↗
• MalfunctionNov 13, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE ULTRASOUND TIP WAS FOUND BENT BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671913 ↗
• MalfunctionJul 22, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT PHACOEMULSIFICATION (PHACO) TIP WAS FOUND BENT WHEN OPENED BEFORE THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792011 ↗
• MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368779 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT PATIENT EXPERIENCED CREAM DUST WAS GENERATED IN A CASE WHERE NUCLEAR HARDNESS WAS NOT THAT HIGH AND BURNS ALSO APPEARED ON THE WOUND DURING CATARACT WITH (IOL IMPLANT) SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: Eye Burn

  MAUDE report 19307975 ↗
• MalfunctionFeb 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PHYSICIAN REPORTED THAT TIP WAS WOBBLY DURING THE 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 18648906 ↗
• MalfunctionDec 22, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP WAS FOUND BENT BEFORE CATARACT SURGERY WITH INTRAOCULAR IMPLANT. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18381565 ↗
• MalfunctionDec 4, 2023Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT METAL PIECE-LIKE FOREIGN MATERIAL WAS FOUND IN THE PATIENT'S EYE DURING US AND FOREIGN MATERIAL REMOVAL PERFORMED WAS NOT COMPLETED AND REMAINS IN THE EYE. THE TIP CLOGGED DURING THE PROCESS AND METALLIC GLITTER MATERIAL ENTERED THE EYE. REMOVED AS MUCH AS POSSIBLE, BUT A SMALL AMOUNT REMAINED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264062 ↗
• MalfunctionSep 26, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP WAS FOUND BENT BEFORE THE CATARACT [WITH INTRAOCULAR (IOL) IMPLANT] SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816990 ↗
• MalfunctionFeb 9, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED TIP WAS FOUND TO BE BENT WHEN OPENED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF THE PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16331748 ↗
• MalfunctionJan 4, 2023Material Twisted/Bent; Material Twisted/Bent

  AS PER INTERNAL REVIEW IT WAS CONFIRMED THAT THE REPORTED EVENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE DEVICE MALFUNCTION AND WOULD NEITHER RESULT IN A RECURRENCE OF A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094925 ↗
• MalfunctionOct 6, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THE NEEDLE INSIDE THE TIP WAS FOUND BENT WHEN THE AIR BYPASS SYSTEM (ABS) TIP WAS OPENED DURING A CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549352 ↗
• MalfunctionJul 28, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED MICRO FLARE TIP WAS FOUND DISTORTED DURING ATTEMPTING TO CONNECT IT TO THE ULTRASOUND HANDPIECE WHEN OPENED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122003 ↗
• MalfunctionMay 30, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION FAILURE OCCURRED DURING THE ULTRASOUND (US) PHASE OF THE CATARACT PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14540245 ↗