Alcon 8065752212Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00380657522125), received between Jul 28, 2021 and Sep 25, 2026 — classified as 3 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (29 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Obstruction of Flow

  A healthcare professional reported that the product could not be used due to a pack blockage during cataract with intraocular lens implantation surgery. The surgery was completed after replacing the product with another one. There was no information about patient impact.This report pertains to the first of the two products involved in this complaint.

  Patient problems: Insufficient Information

  MAUDE report 50898940 ↗
• MalfunctionSep 25, 2026Obstruction of Flow

  A healthcare professional reported that the product could not be used due to a pack blockage during cataract with intraocular lens implantation surgery. The surgery was completed after replacing the product with another one. There was no information about patient impact.This report pertains to the second of the two probes involved in this complaint.

  Patient problems: Insufficient Information

  MAUDE report 50898910 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Suction Problem

  A PHYSICIAN REPORTED THAT CASSETTE LEAKED WATER CAUSED NO ASPIRATION DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684820 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Suction Problem

  A PHYSICIAN REPORTED THAT CASSETTE LEAKED WATER CAUSED NO ASPIRATION DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684816 ↗
• MalfunctionFeb 17, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN ABNORMAL DECREASE IN ASPIRATION FUNCTION DURING INTRAOCULAR IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION CONFIRMED THAT THE INCIDENT OCCURRED DURING THE QUADRANT MODE OF INTRAOCULAR LENS IMPLANTATION SURGERY, AND THE SURGERY WAS COMPLETED WITHOUT ANY DIRECT HARM TO THE PATIENT. DURING THE PROCEDURE, THE SUCTION DROPPED SIGNIFICANTLY. ALL THE STEPS, SUCH AS PERFORMING REFLUX, REPLACING THE PHACOEMULSIFICATION TIP, AND USING A SYRINGE ON THE ASPIRATION LINE TO PERFORM BALANCED SALT SOLUTION SHOOTING WERE CARRIED OUT, BUT THE ISSUE PERSISTED. THE CASSETTE WAS THEN REPLACED, AND THE SURGERY CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361009 ↗
• MalfunctionFeb 12, 2026Infusion or Flow Problem

  A NURSE REPORTED THAT POOR AIRTIGHTNESS, THE ANTERIOR CHAMBER COLLAPSED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 24320537 ↗
• MalfunctionFeb 12, 2026Suction Problem

  A NURSE REPORTED THAT SUCTION DID NOT FUNCTION IN SCULPT MODE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION REPORTED ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24320283 ↗
• MalfunctionJan 13, 2026Suction Problem; Obstruction of Flow; Air/Gas in Device

  A CUSTOMER REPORTED VIA THE HEALTH AUTHORITY THAT MANY BUBBLES, SQUEAKING NOISES, AND INSUFFICIENT SUCTION WERE GENERATED IN THE FLUID BAG OF THE CASSETTE, MAKING IT UNUSABLE DURING LEFT-EYE CATARACT PHACOEMULSIFICATION AND ASPIRATION SURGERY WITHOUT INTRAOCULAR IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER A NEW ULTRASONIC EMULSION FLOW MANAGEMENT SYSTEM PACKAGE WITHOUT SUPER NIPPLE AND NO PERFUSION SILICONE RESIN SLEEVE WAS REPLACE WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24064304 ↗
• MalfunctionJan 12, 2026Obstruction of Flow

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE TUBING WAS OBSTRUCTED DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENSES IMPLANT). THE PHACOEMULSIFICATION MACHINE DISPLAYED ERROR CODE AND AFTER REPLACING THE PHACOEMULSIFICATION TIP, ERROR CODE WAS INDICATED. THE CASSETTE WAS THEN REPLACED, AND THE DEVICE FUNCTIONED NORMALLY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049990 ↗
• MalfunctionJan 12, 2026Break

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THE BALANCED TIP WAS BROKEN DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENSES IMPLANT). THE SPARE BALANCED TIP WAS IMMEDIATELY REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032643 ↗
• MalfunctionJan 6, 2026Failure to Prime; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT, LEAKING FROM ASPIRATION TUBE AND FLUIDIC MANAGEMENT SYSTEM DID NOT PRIME DURING THE SURGERY. THE PROCEDURE TYPE, SURGERY COMPLETION DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23971739 ↗
• MalfunctionJan 5, 2026Obstruction of Flow

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A LOT OF NOISE (CASSETTE SEEMS AS IF THE WHEELS WHERE IT FITS ARE CONSTANTLY RUBBING) IN THE PHACOEMULSIFICATION STEP DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE FMS (FLUIDICS MANAGEMENT SYSTEM) PAK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955056 ↗
• MalfunctionDec 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE FLUID FLOW DECREASES SLOWLY, AND THE FLOW RATE DECREASES, RESULTING IN ANTERIOR CHAMBER COLLAPSE AND NOTICEABLE SURGE PHENOMENON DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGEON CONTINUED USING THE PRODUCT TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23836254 ↗
• MalfunctionDec 8, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT THERE WAS POOR FLUID FLOW WHEN USING THE FLUIDIC MANAGEMENT SYSTEM (FMS), RESULTING IN UNSTABLE ANTERIOR CHAMBER DURING THE CATARACT [WITHOUT INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23739700 ↗
• MalfunctionNov 24, 2025Inability to Irrigate; Inability to Irrigate

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE FLUIDICS MANAGEMENT SYSTEM HAD POOR ANTERIOR WATER FLOW DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628557 ↗
• MalfunctionNov 6, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT VACUUM DID NOT GO UP EVEN WHEN SURGEON FULLY STEPS ON THE FOOT SWITCH AT AN UNKNOWN TIMING FOR THE CATARACT WITHOUT INTRAOCULAR SURGERY. ASPIRATION MODE WAS IN CROP STEP. NO ERROR OR WARNING SHOWED WHEN VACUUM NOT UP. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ASPIRATION MODE WAS IN CROP STEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485450 ↗
• MalfunctionOct 24, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN ASPIRATION FAILURE OCCURRED DURING ULTRASOUND MODE AND BLOCKAGE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (IOL). DESPITE THE TIP AND A HANDPIECE WERE REPLACED WITH ANOTHER ONES AND REBOOT WAS DONE, THE SITUATION COULD NOT IMPROVE. AFTER REPLACING THE CASSETTE PAK WITH ANOTHER ONE, THE SURGERY WAS RESTARTED. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379907 ↗
• MalfunctionOct 24, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  A NURSE REPORTED THAT ERROR MESSAGE WAS DISPLAYED (TUNE FAILED-LOOSE TIP) BEFORE CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377395 ↗
• MalfunctionSep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED INTRAOPERATIVE PERFUSION PRESSURE WAS INSUFFICIENT, RESULTING IN AN INTERRUPTION OF PERFUSION DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039842 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN ABNORMAL NOISE WAS GENERATED FROM A CASSETTE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23039331 ↗
• MalfunctionSep 10, 2025Obstruction of Flow; Obstruction of Flow

  A CONSUMER REPORTED THAT SOME UNUSUAL SOUNDS FROM FLUIDICS MANAGEMENT SYSTEM DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE FLUIDICS MANAGEMENT SYSTEM WITH NEW ONE. THERE WAS PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014717 ↗
• MalfunctionSep 3, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT INSUFFICIENT PERFUSION OCCURRED AND LEADING TO ANTERIOR CHAMBER COLLAPSE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (IOL). THE PACK WAS IMMEDIATELY REPLACED, AND THE SURGERY PROCEEDED SMOOTHLY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22949943 ↗
• MalfunctionSep 2, 2025Air/Gas in Device; Air/Gas in Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA GOVERNMENT AGENCY THAT CONTINUOUS BUBBLES WERE OBSERVED IN THE TUBING OF THE CASSETTE, WHICH ENTERED THE ANTERIOR CHAMBER AND SEVERELY AFFECTED THE SURGICAL FIELD DURING THE CATARACT [WITHOUT INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. CONSIDERING PATIENT SAFETY, THE DUAL-PUMP TUBING SET WAS IMMEDIATELY DISCONTINUED. AFTER REPLACING IT WITH A NEW CASSETTE, THE AIR BUBBLES DISAPPEARED, AND THE SURGERY WAS SAFELY COMPLETED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22932306 ↗
• MalfunctionAug 20, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT STRANGE NOISE DURING CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22847836 ↗
• MalfunctionAug 20, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT STRANGE NOISE DURING CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22847835 ↗