Alcon, TurboSonics, Flared ABS 8065740806Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380657408061), received between Jun 30, 2023 and Oct 17, 2025 — classified as 6 malfunctions.

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

• MalfunctionOct 17, 2025Break; Break

  A HA SYSTEM REPORTED THAT SLEEVE OF THE PHACOEMULSIFICATION TIP RUPTURED DURING CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321308 ↗
• MalfunctionApr 21, 2025Break; Break

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PHACOEMULSIFICATION TIP HAD BROKEN DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT (IOL)). THE SURGERY WAS SCHEDULED FOR RIGHT EYE OF THE PATIENT. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF TIP WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875030 ↗
• MalfunctionMay 2, 2024Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP WAS SUDDENLY BROKEN AND THE SURGERY COULD NOT BE CONTINUED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (IOL). AFTER REPLACING THE HANDPIECE AND PHACO TIP, THE SURGERY COMPLETED SMOOTHLY, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234154 ↗
• MalfunctionApr 5, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT PHACO TIP WAS BENT AND WAS BROKEN DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051626 ↗
• MalfunctionJul 24, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT ASPIRATION WAS ABLE TO PERFORM NORMALLY AT UNKNOWN TIMING OF CATARACT SURGERY. SURGERY COMPLETED WITH THE REPLACEMENT OF THE TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377344 ↗
• MalfunctionJun 30, 2023Break; Break

  A CUSTOMER REPORTED THAT BROKEN NIPPLE FOUND DURING THE CATARACT SURGERY. ANOTHER SET OF NIPPLE HANDLES REPLACED, AND THE SURGERY WAS COMPLETED NORMALLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235650 ↗