Alcon 8065752918Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00380657529186), received between Mar 18, 2021 and Aug 10, 2026 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Suction Problem; Obstruction of Flow

  A non-healthcare professional reported that the suction lost and occlusion message was displayed during phaco sculpt step of the cataract surgery (with intraocular lenses implant). The surgery was completed after replacing the product with new one. There was no patient contact and no report of the patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193240 ↗
• MalfunctionAug 10, 2026Suction Problem; Obstruction of Flow

  A non-healthcare professional reported that the suction lost and occlusion message was displayed during phaco sculpt step of the cataract surgery (with intraocular lenses implant). The surgery was completed after replacing the product with new one. There was no patient contact and no report of the patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190464 ↗
• MalfunctionFeb 24, 2026Suction Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED LOSS OF SUCTION AT AN UNKNOWN TIMING. THE SURGERY DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24430803 ↗
• MalfunctionDec 24, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  A PHYSICIAN REPORTED THAT AFTER SETTING THE CASSETTE DURING THE TEST, THE TIP WAS LOOSE AND THERE WAS A RETIGHTENING ERROR CHIP WAS FIXED BUT IT DIDN'T IMPROVE. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH THE SAME PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23888085 ↗
• InjuryNov 25, 2025Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT NO IRRIGATION CAME OUT DURING ULTRASOUND MODE AND ADVISORY CODES WERE DISPLAYED. BECAUSE ASPIRATION WAS APPLIED WITHOUT IRRIGATION, THE POSTERIOR CAPSULE RUPTURED. DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE PACK WAS REPLACED, AND THE ANTERIOR VITRECTOMY TREATMENT WAS PERFORMED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23641721 ↗
• MalfunctionOct 21, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE ORIGIN OF THE BENT PART OF PHACO TIP WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23345484 ↗
• MalfunctionOct 15, 2025Break; Break

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT BALANCE TIP FRACTURED AT AN UNKNOWN TIMING. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23298901 ↗
• MalfunctionJul 30, 2025Break; Break

  A PHYSICIAN REPORTED THAT BALANCED TIP WAS FOUND CRACKED AT UNKNOWN TIME. THE SURGERY AND PATIENT DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE CATARACT SURGERY WAS COMPLETED BY REPLACING THE PHACO TIP. THERE WAS NO PATIENT CONTACT WITH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662267 ↗
• MalfunctionJul 25, 2025Material Twisted/Bent; Material Twisted/Bent

  AN HEALTH CARE PROFESSIONAL REPORTED THAT BALANCE TIP BENT AND DEFORM BEFORE INTRAOCULAR LENS IMPLANT SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22608219 ↗
• MalfunctionJul 24, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE THAT CRACK ON THE TIP NEAR ASPIRATION BYPASS SYSTEM (ABS) DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT AND IMPACT.

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

  MAUDE report 22587762 ↗
• MalfunctionApr 30, 2025Break; Break

  HEALTH CARE PROFESSIONAL REPORTED THAT BALANCE TIP BROKE DURING THE SURGERY. THERE WAS NO REPORT OF PROCEDURE DETAILS AND PATIENT IMPACT. ADDITIONAL INFORMATION WAS PROVIDED THAT EVENT OCCURRED DURING CATARACT SURGERY AT QUADRANT REMOVAL STEP. PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF NEW TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932821 ↗
• MalfunctionApr 28, 2025Suction Problem; Obstruction of Flow; Infusion or Flow Problem; Suction Problem; Obstruction of Flow; Infusion or Flow Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE QUADRANT STEP OF CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, HAD DECREASED FLOW AND VACUUM AFTER HALF OF THE NUCLEUS WAS REMOVED. THE PHACOEMULSIFICATION OCCLUSION TONE WAS GOING OFF. THEY FLUSHED THE HANDPIECE AND TIP AND TRIED AGAIN. THE ISSUE STILL PERSISTED. THE NEXT ACTION WAS TO EXCHANGE THE TIP WITH A NEW TIP. THE OCCLUSION TONE WAS STILL ACTIVATED AND THE PROBLEM STILL EXISTED. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916850 ↗
• InjuryApr 4, 2025Break; Break

  A NURSE REPORTED THAT THE BALANCED PHACOEMULSIFICATION TIP BROKE DURING THE LENS EMULSIFICATION PORTION OF CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. A METAL PIECE OF THE TIP BECAME DISLODGED INSIDE THE PATIENT'S EYE. THE SURGEON HAD TO WIDEN THE WOUND TO REMOVE THE BROKEN TIP AND USED SUTURES TO CLOSE THE WOUND DUE TO ITS SIZE. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THE PATIENT¿S SYMPTOMS ARE BEING MONITORED FREQUENTLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21772618 ↗
• InjuryApr 4, 2025Break; Break

  THE NURSE REPORTED THAT BALANCED TIP BROKE INTO TWO PIECES, WITH THE METAL PIECE OF THE TIP BEING DISLODGED INSIDE THE PATIENT'S EYE. THE SURGEON HAD TO WIDEN THE WOUND TO REMOVE IT DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGEON HAS USED SUTURES TO CLOSE WIDEN WOUND. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW TIP. THERE WAS NO COMPLICATION TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771092 ↗
• InjuryApr 2, 2025Break; Break

  THE NURSE REPORTED THAT BALANCED TIP BROKE INTO TWO PIECES, WITH THE METAL PIECE OF THE TIP BEING DISLODGED INSIDE THE PATIENT'S EYE. THE SURGEON HAD TO WIDEN THE WOUND TO REMOVE IT DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGEON HAS USED SUTURES TO CLOSE WIDEN WOUND. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW TIP. THERE WAS NO COMPLICATION TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749805 ↗
• MalfunctionMar 4, 2025Suction Problem; Suction Problem

  A PHARMACIST REPORTED WHILE THE SURGEON TRIED TO ASPIRATE THE QUARTERS, THERE WAS NO SUCTION AND A MESSAGE APPEARED ON THE MACHINE SCREEN: "OCCLUSION" DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED BY USING ANOTHER CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511704 ↗
• MalfunctionFeb 26, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE BALANCE TIP WAS BROKEN DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466342 ↗
• MalfunctionJan 21, 2025Suction Failure; Suction Failure

  A NURSE REPORTED THAT THERE WAS NO VACUUM DURING THE IRRIGATION AND ASPIRATION MODE WHEN TRIED TO REMOVE CORTEX DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195554 ↗
• MalfunctionNov 8, 2024Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  OTHER HEALTH CARE PROFESSIONAL REPORTED THAT PRESSURE WAS UNSTABLE DURING PHACO MODE AND ABNORMAL SOUND HEARD AT FLUIDIC MANAGEMENT SYSTEM (FMS). THE PROCEDURE TYPE WAS UNKNOWN. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20640655 ↗
• MalfunctionSep 11, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT VACUUM DID NOT ASPIRATE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER CHANGED A NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192417 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT INVASION OCCURRED IN THE IRIS AFTER THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY IN WHICH THE BALANCED TIP WAS USED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Eye Injury

  MAUDE report 19960465 ↗
• MalfunctionMay 3, 2024Break; Break

  A PHYSICIAN REPORTED THAT THERE WAS A VERTICAL CRACK IN THE BALANCE TIP DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING A NEW TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240175 ↗
• MalfunctionApr 19, 2024Break; Break

  A PHYSICIAN REPORTED THAT BALANCE TIP BROKE DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS COMPLETED BY USING A NEW TIP. THERE WAS NO PATIENT HARM (NO SERIOUS INJURY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141909 ↗
• MalfunctionApr 18, 2024Break; Break

  A PHYSICIAN REPORTED THAT THE BALANCED TIP BROKE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135309 ↗
• MalfunctionApr 18, 2024Break; Break

  THE PHYSICIAN REPORTED THAT THE BALANCE TIP BROKE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT (IOL)). THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF NEW TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131650 ↗