Alcon 8065752216Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380657522163), received between Jun 9, 2021 and Feb 6, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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-2407-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Suction Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THE NEGATIVE PRESSURE DISAPPEARANCE AND UNSTABLE FLUID FLOW DURING CATARACT WITHOUT INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275854 ↗
• MalfunctionDec 16, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE HANDPIECE COULD NOT PASS THE TEST AND INDICATING THAT THE PHACOEMULSIFICATION TIP WAS LOOSE BEFORE CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY FOR THE LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE STERILIZATION TIP WITH A NEW ONE, THEN THE HANDPIECE TEST PASSED. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO THE PHACOEMULSIFICATION TIP INVOLVED IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814460 ↗
• MalfunctionDec 10, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE DID NOT DRAW THE SALINE DURING SURGERY. PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23774949 ↗
• MalfunctionAug 27, 2025Failure to Prime; Infusion or Flow Problem; Failure to Prime; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT CASSETTE HAD A POOR FLUID FLOW AND COULD NOT PASS THE TEST DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910078 ↗
• MalfunctionMay 2, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE NEEDLE WAS LOOSE BEFORE CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER TIGHTENING THE SAME NEEDLE WITH A NEEDLE WRENCH. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949366 ↗
• MalfunctionDec 11, 2024Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  A NURSE REPORTED THAT THE PHACOEMULSIFICATION FLUID MANAGEMENT SYSTEM PACKAGE HAD LEAKED LIQUID, THE FLUID FLOW OF MOST PRODUCTS WAS BLOCKED OR EVEN ABSENT, RESULTING IN ABNORMAL ANTERIOR CHAMBER DURING SURGERY AND INCREASED SURGICAL RISKS. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 20900642 ↗
• MalfunctionDec 3, 2024Break; Break

  A PHYSICIAN REPORTED THAT BENT TIP WAS OBSERVED DURING CATARACT (WITH INTRAOCULAR LENS IMPLANT) SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20829378 ↗
• MalfunctionNov 14, 2024Complete Blockage; Leak/Splash; No Flow; Complete Blockage; Leak/Splash; No Flow

  NURSE REPORTED THAT PRODUCTS HAD BLOCKAGE OR EVEN NO FLUID FLOW, RESULTING IN ABNORMAL ANTERIOR CHAMBER AND INCREASING SURGICAL RISKS DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN, 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 20681785 ↗
• MalfunctionSep 26, 2024Inability to Irrigate; Inability to Irrigate

  THE NON HEALTHCARE PROFESSIONAL REPORTED THAT THE PERFUSION LIQUID DID NOT FLOW DURING SURGERY. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308429 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE TIP OF THE ULTRASOUND NEEDLE WAS BENT DURING PREPARATION FOR PHACOEMULSIFICATION (PHACO) OF CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE NEW PHACO TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20178966 ↗
• MalfunctionAug 2, 2024Suction Failure; Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE CASSETTE STOPPED SUCTIONING POST THE VISCO STEP DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANT). THE PROCEDURE WAS COMPLETED WITH A NEW CASSETTE. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19890348 ↗
• MalfunctionJul 11, 2024Inability to Irrigate; Inability to Irrigate

  A PHARMACIST REPORTED THAT CASSETTE DID NOT IRRIGATE AND ERROR CODES WERE DISPLAYED DURING CATARACT WITH (INTRAOCULAR LENS IMPLANT) SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718563 ↗
• MalfunctionJul 10, 2024Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE NO VACUUM PRESSURE IN CASSETTE DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708593 ↗
• MalfunctionMay 16, 2024Suction Problem; Suction Problem

  A NURSE REPORTED THAT NO VACUUM AT THE LEVEL OF CORTICAL MASSES DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329833 ↗
• MalfunctionMay 15, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT THERE WAS LACK OF VACUUM DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19317759 ↗
• MalfunctionMay 15, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT VERY WEAK VACUUM PRESSURE WITH MAXIMUM VALUE GOING TO 100 DURING CORTEX MODE OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19317756 ↗
• MalfunctionMay 10, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT THE LACK OF NEGATIVE PRESSURE AT THE STAGE OF THE PROCEDURE CORTICAL CHECKOUT DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS A PATIENT CONTACT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283815 ↗
• MalfunctionMay 10, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT LACK OF NEGATIVE PRESSURE DURING THE STAGE OF THE PROCEDURE CORTICAL CHECKOUT OF SURGERY. THE TYPE OF PROCEDURE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283813 ↗
• MalfunctionMay 4, 2024Suction Failure; Suction Failure

  THE NURSE REPORTED THAT THE LACK OF VACUUM DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS PATIENT CONTACT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244733 ↗
• MalfunctionMay 2, 2024Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE LACK OF VACUUM DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228049 ↗
• MalfunctionOct 13, 2023Inability to Irrigate; Inability to Irrigate

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE DID NOT ADVANCE DURING IRRIGATION DURING THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928362 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE SUCTION OF THE CASSETTE WAS STOPPED DURING PHACOEMULSIFICATION CATARACT SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE CASSETTE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116369 ↗
• MalfunctionMay 30, 2023Suction Failure; Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE CASSETTE DID NOT ASPIRATE DURING CATARACT SURGERY, IT DID NOT GAVE ANY ERROR MESSAGE ON CONSOLE. THE CASSETTE WAS REPLACED AND CHANGED WITH A NEW ONE AND PROBLEM WAS SOLVED. THE PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027742 ↗
• MalfunctionJul 21, 2022Suction Failure; Suction Failure

  A CUSTOMER REPORTED THE "ERROR 163" MESSAGE APPEARED AND THERE WAS NO ASPIRATION. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072340 ↗
• MalfunctionJul 21, 2022Suction Failure; Suction Failure

  A CUSTOMER REPORTED THE "ERROR 163" MESSAGE APPEARED AND THERE WAS NO ASPIRATION. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072336 ↗