Alcon 8065752193Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380657521937), received between Oct 7, 2022 and May 30, 2025 — classified as 1 injury, 13 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. 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-2407-2023 · 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.

• MalfunctionMay 30, 2025Incomplete or Inadequate Connection; Suction Failure; Incomplete or Inadequate Connection; Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT A WEIRD NOISE AND DID NOT VACUUM OR ALLOW LIQUID OUT AND MACHINE STATED THAT THE TIP WAS LOOSE BEFORE CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER BATCH PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112609 ↗
• MalfunctionMay 27, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ADDITIONAL INFORMATION REPORTED THAT THE PROCEDURE TYPE WAS CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THIS REPORT PERTAIN TO THE PHACOEMULSIFICATION TIP INVOLVED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090095 ↗
• MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE PHACOEMULSIFICATION TIP WAS BENT BEFORE CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PHACOEMULSIFICATION TIP WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564476 ↗
• MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE PHACOEMULSIFICATION TIP WAS BENT DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE PROCEDURE WAS COMPLETED BY REPLACING THE PHACOEMULSIFICATION TIP WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564474 ↗
• MalfunctionJan 18, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS NO PERFORATION WAS NOTICED IN THE SLEEVE DURING CATARACT INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE AND PATIENT HARM DETAILS WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18533278 ↗
• MalfunctionOct 18, 2023Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED SKEW PHACOEMULSIFICATION TIP BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING ANOTHER TIP. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956502 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY PATIENT EXPERIENCED BURN ON THE MAIN INCISION AND SURGICAL STITCHES WERE NEEDED TO CLOSE THE INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Burn

  MAUDE report 17304328 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT TIP WOULD NOT TIGHTEN. THE TIP WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806296 ↗
• MalfunctionFeb 28, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED NO ASPIRATION FLOWED DURING SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH NEW CASSETTE AND THEN ASPIRATION FLOW FULLY RESTORED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451395 ↗
• MalfunctionFeb 22, 2023Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED A PIECE OF METAL FROM THE PHACOEMULSIFICATION (PHACO) TIP CAME OFF DURING THE PHACO PHASE OF A PROCEDURE AND WAS REMOVED FROM THE EYE WITHOUT ANY DAMAGE OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE CONFIRMING THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A PHACOEMULSIFICATION (PHACO) NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419086 ↗
• MalfunctionNov 22, 2022Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED A PIECE OF METAL FROM THE PHACOEMULSIFICATION (PHACO) TIP CAME OFF DURING THE PHACO PHASE OF A PROCEDURE AND WAS REMOVED FROM THE EYE WITHOUT ANY DAMAGE OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE CONFIRMING THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A PHACOEMULSIFICATION (PHACO) NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842937 ↗
• MalfunctionNov 4, 2022Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  A PHYSICIAN REPORTED THERE WAS NO ASPIRATION FLOW IN VISCO MODE OF A SURGERY. VISCO IS THE ONLY STEP WHERE SO MUCH VISCOELASTIC MATERIAL HAD TO BE REMOVED. VERY OCCASIONALLY THE ASPIRATION FLOW BLOCKS IN THE VERY LAST STEP, THEY THINK IT WAS A BLOCKAGE OF THE TUBING. THE PATIENT WAS TREATED WITH DIAMOX. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726689 ↗
• MalfunctionOct 20, 2022Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  CORRECTED INFORMATION PROVIDED IN D.4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638632 ↗
• MalfunctionOct 7, 2022Suction Failure; Suction Failure

  A CUSTOMER REPORTED THERE WAS NO FLOW OF VACUUM AND IT STOPPED WORKING DURING A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT ON PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561280 ↗