Alcon 8065752181Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00380657521814), received between Jun 16, 2021 and Feb 27, 2026 — classified as 1 injury, 41 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (11 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ABNORMAL ASPIRATION DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469668 ↗
• MalfunctionDec 29, 2025Suction Problem; Ambient Noise Problem; Suction Problem; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT POOR ASPIRATION WAS CONFIRMED DURING ULTRA SOUND MODE, AND THE OPERATING NOISE WAS LOUDER THAN USUAL DURING ASPIRATING FOR CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). 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 23904794 ↗
• MalfunctionDec 24, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THERE WAS ASPIRATION FAILURE IN ULTRASOUND MODE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 23887512 ↗
• MalfunctionDec 15, 2025Obstruction of Flow; Obstruction of Flow

  AN OPHTHALMOLOGIST REPORTED THAT THE ABNORMAL NOISE ARE GENERATED FROM THE PACK WHEN USING ULTRASOUND DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23800146 ↗
• MalfunctionDec 11, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ABNORMAL NOISE OCCURRED DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23777583 ↗
• MalfunctionNov 21, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT A STRANGE SOUND WAS HEARD DURING ASPIRATION, AND A CONNECTOR PART COULD NOT BE CONNECTED TO THE IRRIGATION/ASPIRATION HANDPIECE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO THE ISSUE RELATED TO A STRANGE SOUND THAT WAS HEARD IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613702 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT A STRANGE SOUND WAS HEARD DURING ASPIRATION, AND A CONNECTOR PART COULD NOT BE CONNECTED TO THE IRRIGATION/ASPIRATION (I/A) HANDPIECE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO THE ISSUE RELATED TO A CONNECTOR PART COULD NOT BE CONNECTED TO THE I/A HANDPIECE IN THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613700 ↗
• MalfunctionNov 17, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED ABNORMAL SOUND FROM THE CASSETTE PACK DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23566781 ↗
• MalfunctionNov 4, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THERE WAS AN AUDIBLE NOISE DURING ASPIRATION DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23462159 ↗
• MalfunctionOct 24, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN ABNORMAL NOISE WAS HEARD FROM THE CASSETTE OR THE BAG DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378203 ↗
• MalfunctionOct 15, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT SUCTION PRESSURE DID NOT INCREASE 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 23297688 ↗
• MalfunctionOct 15, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN ABNORMAL NOISE WAS GENERATED AROUND A CASSETTE 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 23291744 ↗
• MalfunctionDec 13, 2024Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION WAS WEAK DURING CATARACT (WITH INTRAOCULAR LENS IMPLANT) SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PAK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922233 ↗
• MalfunctionDec 12, 2024Decrease in Suction; Decrease in Suction

  A PHYSICIAN REPORTED THAT THE CUMULATIVE DISSIPATED ENERGY (CDE) VALUE DID NOT INCREASE AND REMAINED AT ZERO DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES 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 20910331 ↗
• MalfunctionNov 25, 2024Noise, Audible; Noise, Audible

  A PHYSICIAN REPORTED THAT SYSTEM MESSAGE WAS DISPLAYED MULTIPLE TIMES AND AN ABNORMAL SOUND WAS HEARD FROM THE PACK DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 20769961 ↗
• MalfunctionOct 28, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED AND ASPIRATION DID NOT INCREASE DURING IRRIGATION AND ASPIRATION MODE OF CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY USING A SYRINGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542893 ↗
• MalfunctionOct 17, 2024Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED AND CONTINUED TO HEAR AN OBSTRUCTION SOUND DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT AND STOPPED ASPIRATING ALTOGETHER AFTER INTRAOCULAR LENS INSERTION, DURING IRRIGATION/ASPIRATION WITHOUT HEALON. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469723 ↗
• MalfunctionOct 9, 2024Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  A PHYSICIAN REPORTED THAT JUST AFTER ULTRA SOUND MODE STARTED, AN OCCLUSIVE SOUND KEPT RINGING AND ASPIRATION COULD NOT BE PERFORMED AT ALL DURING CATARACT SURGERY. DESPITE CONNECTED AN IRRIGATION AND ASPIRATION TUBE AND PERFORMED A PRIMING AGAIN, THE SITUATION DID NOT IMPROVED AT ALL. THE SURGERY WAS RESUMED AND COMPLETED AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405809 ↗
• InjuryAug 22, 2024Inability to Irrigate; Inability to Irrigate

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE AFFECTED EYE WAS THE RIGHT EYE AND THAT THE NUCLEAR HARDNESS GRADE WAS THREE. ANTERIOR CHAMBER DYSPLASIA OCCURRED DUE TO POOR IRRIGATION DURING THE IRRIGATION AND ASPIRATION STEP.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased

  MAUDE report 20033273 ↗
• MalfunctionJul 22, 2024Ambient Noise Problem; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT A STRANGE "CLUNKING" NOISE WAS HEARD WHEN THE FOOTSWITCH PEDAL WAS RELEASED IN THE IRRIGATION/ASPIRATION STEP DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790563 ↗
• MalfunctionMay 13, 2024Inability to Irrigate; Inability to Irrigate

  A NURSE REPORTED THAT IRRIGATION FAILURE OCCURRED DURING CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PAK WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296312 ↗
• MalfunctionMay 6, 2024Complete Blockage; Suction Problem; Complete Blockage; Suction Problem

  A PHYSICIAN REPORTED THAT THE BLOCKAGE SOUND WAS HEARD AND ASPIRATION COULD NOT BE APPLIED DURING CATARACT SURGERY. THE IRRIGATION TUBE WAS CONNECTED AND PRIMING PERFORMED AGAIN, BUT THERE WAS NO IMPROVEMENT. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER CASSETTE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247509 ↗
• MalfunctionDec 12, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING ULTRASOUND (US) MODE, DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). 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 18308325 ↗
• MalfunctionOct 18, 2023Inability to Irrigate; Inability to Irrigate

  THE PHYSICIAN REPORTED THAT IRRIGATION FAILURE OCCURRED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

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

  MAUDE report 17956826 ↗
• MalfunctionOct 6, 2023Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED DURING SURGERY. THE IRRIGATION FLOW WAS WEAK AND COULD MERELY COME OUT. THE PROCEDURE WAS COMPLETED AFTER THE PACK WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884893 ↗