Alcon 8065752203Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380657522033), received between Dec 7, 2021 and Jan 17, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2026Suction Problem

  A PHARMACIST REPORTED THAT THE DEFECTIVE ASPIRATION OCCURRED DURING SURGERY. THE PROCEDURE TYPE AND OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24105458 ↗
• MalfunctionJan 13, 2026Suction Problem

  A PHARMACIST REPORTED THAT NO ASPIRATION AT UNKNOWN TIMING OF CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF CASSETTE WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24051331 ↗
• MalfunctionDec 17, 2025Suction Problem; Suction Problem

  A PHARMACIST REPORTED THAT THERE WAS NO ASPIRATION DURING SURGERY. PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY BY REPLACING ANOTHER CASSETTE. THERE WAS INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23827574 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  A PHARMACIST REPORTED THAT THERE WAS A DEFECTIVE ASPIRATION (LEAK IN THE SYSTEM) DURING SURGERY. THE PROCEDURE TYPE AND PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23712419 ↗
• MalfunctionDec 3, 2025Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  A PHARMACIST REPORTED THAT THERE WAS DEFECTIVE ASPIRATION AND LEAK OBSERVED DURING SURGERY. THE PROCEDURE TYPE, SURGERY COMPLETION DETAILS AND IMPACT TO THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23702393 ↗
• MalfunctionJul 30, 2025Suction Failure; Suction Failure

  A PHARMACIST REPORTED THAT CASSETTE HAD NO ASPIRATION FLOW DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER CASSETTE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662945 ↗
• MalfunctionJun 24, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE TIP OF THE TIP BROKE OFF IN THE EYE AND THE ENTIRE SLEEVE WAS REMOVED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319659 ↗
• MalfunctionFeb 4, 2025Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  A NURSE REPORTED THAT THERE WAS NO ASPIRATION FLOW DURING THE CORTEX STEP DUE TO OCCLUSION AND THE ISSUE WAS SAME AT ULTRASOUND STEP DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301777 ↗
• MalfunctionJul 22, 2024Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED DURING CATARACT SURGERY AN OPHTHALMIC PHACOEMULSIFICATION HANDPIECE (HP) EXHIBITED LACK OF ASPIRATION, CLOGGING AND A MILKY FLUID IN EYE THAT WAS DIFFICULT TO ASPIRATE. AN OPHTHALMIC PHACOEMULSIFICATION TIP (PHACO TIP) WAS ALSO SLIGHTLY CLOGGED AFFECTING THE SCULPT PHASE OF THE SURGERY. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THE PHACOEMULSIFICATION HANDPIECE WAS NOT FLUSHED PROPERLY RESULTED IN HAVING DRIED BALANCED SALT SOLUTION (BSS) THAT OBSTRUCTED THE FLOW CREATING OCCLUSION AND CONFIRMED THAT THERE WAS NO PATIENT HARM. THIS IS THE SECOND PRODUCT REPORT OF TWO PRODUCTS REPORTED. THIS REPORT IS FOR THE PHACOEMULSIFICATION TIP (PHACO TIP) INVOLVED IN THE REPORTED EVENT.

  Patient problems: Fluid Discharge

  MAUDE report 19790185 ↗
• MalfunctionDec 5, 2023Failure to Infuse; Suction Failure; Failure to Infuse; Suction Failure

  A PHYSICIAN REPORTED ERROR CODE WAS DISPLAYED: ULTRASOUND, IRRIGATION AND ASPIRATION FAILURE AND IT WAS IMPOSSIBLE TO USE FLUID DISK DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PAK WITH A BACKUP. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM. PENDING EXTERNAL RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267187 ↗
• MalfunctionMay 4, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION FAILURE OCCURRED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. IT WAS UNKNOWN WHETHER THE INCIDENT HAPPENED DURING ULTRASOUND (US) OR IRRIGATION/ASPIRATION (I/A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866558 ↗
• MalfunctionFeb 27, 2023Break; Break

  A PHYSICIAN REPORTED ULTRASOUND TIP WAS CRACKED AND BROKE INSIDE THE PATIENT'S EYE DURING SURGERY. THE DAMAGED TIP WAS TAKEN OUT OF THE EYE ALONG WITH THE SLEEVE AND DID NOT FALL INTO THE PATIENT EYE. IT WAS NOT REPORTED IF THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE DETAILS WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM SURGEON THAT THERE WAS NO EFFECT OBSERVED ON THE PATIENT, AS THE TIP WAS IMMEDIATELY NOTICED TO BE DAMAGED AND REMOVED FROM THE EYE. THERE WAS NO STRONG INFLAMMATION OBSERVED THE DAY AFTER SURGERY, AND NO PARTICULAR HEALTH PROBLEMS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16446274 ↗
• MalfunctionDec 12, 2022Break; Break

  AN OPHTHALMIC SURGEON REPORTED TIP WAS BROKEN AFTER US OSCILLATION DURING A CATARACT-VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15957943 ↗
• MalfunctionOct 19, 2022Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  AN OPHTHALMIC SURGEON REPORTED ASPIRATION SUDDENLY STOPPED DURING IRRIGATION/ASPIRATION PHASE OF CATARACT PROCEDURE. IT WAS JUDGED TO BE CLOGGED SO THE PAK WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM. THE SAMPLE WAS NOT AVAILABLE BECAUSE IT WAS USED ON A PATIENT WITH AN INFECTION AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631649 ↗
• MalfunctionOct 18, 2022Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  AN OPHTHALMIC SURGEON REPORTED ASPIRATION SUDDENLY STOPPED DURING IRRIGATION/ASPIRATION (I/A) PHASE OF CATARACT PROCEDURE. IT WAS JUDGED TO BE CLOGGED SO THE PAK WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM. THE SAMPLE WAS NOT AVAILABLE BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623148 ↗
• MalfunctionSep 29, 2022Break; Break

  A PHARMACIST REPORTED PHACOEMULSIFICATION TIP WAS BROKEN DURING A SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED .THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508774 ↗
• InjuryDec 7, 2021Suction Failure; Suction Failure

  A PHYSICIAN REPORTED AN IRRIGATION FAILURE AND THE ANTERIOR CHAMBER (AC) WAS UNSTABLE DURING THE ULTRASOUND (US) PHASE OF A CATARACT PROCEDURE. THE PATIENT EXPERIENCED POSTERIOR CAPSULE RUPTURED. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE WHO INDICATED THE POSTERIOR CAPSULE WAS RUPTURED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 12950910 ↗