Alcon, Infiniti, Intrepid 8065752088Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380657520886), received between Mar 29, 2021 and Jun 5, 2024 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Noise, Audible; Noise, Audible

  A PHYSICIAN REPORTED THAT AN ABNORMAL SOUND HEARD WHEN USING THE PRODUCT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469624 ↗
• MalfunctionMay 7, 2024Noise, Audible; Noise, Audible

  A PHYSICIAN REPORTED THAT ABNORMAL NOISE WAS HEARD FROM AROUND THE DRAIN BAG JOINT OF THE PACK DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM AND PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256879 ↗
• MalfunctionApr 18, 2024Ambient Noise Problem; Ambient Noise Problem

  A PHYSICIAN REPORTED THAT THE STRANGE SOUND WAS HEARD DURING SURGERY. THE PROCEDURE DETAILS WERE 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 19131706 ↗
• MalfunctionApr 16, 2024Complete Blockage; Complete Blockage

  THE PHYSICIAN REPORTED THAT ABNORMAL NOISE WAS HEARD FROM THE PAK DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PRODUCT. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114141 ↗
• MalfunctionJan 11, 2024Noise, Audible; Noise, Audible

  A PHARMACIST REPORTED THAT CASSETTE STARTED TO FAIL BY EMITTING A SOUND THAT HAD NEVER BEEN PRESENTED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS OTHER. THERE WAS NO INFORMATION ABOUT PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18492096 ↗
• MalfunctionDec 4, 2023Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THAT NO IRRIGATION IN THE DRAIN BAG AND LEAK FROM AROUND THE DRAIN BAG 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 18264076 ↗
• MalfunctionAug 21, 2023Noise, Audible; Noise, Audible

  A PHYSICIAN REPORTED THAT AN UNFAMILIAR SOUND WAS HEARD FROM THE AREA AROUND THE CASSETTE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584173 ↗
• MalfunctionJul 25, 2023Noise, Audible; Suction Failure; Noise, Audible; Suction Failure

  A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED, AND ABNORMAL NOISE WAS HEARD FROM THE ROLLER AREA DURING CATARACT SURGERY. IRRIGATING SOLUTION DIDN'T SEEM TO BE KEEPING UP, AND THE ANTERIOR CHAMBER BECAME UNSTABLE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN CONFIRMING THAT THE PAK WAS REPLACED AND THE SAME ISSUE WAS RECURRED, HOWEVER THE SURGERY WAS PERFORMED AND COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389915 ↗
• MalfunctionJul 25, 2023Noise, Audible; Suction Failure; Noise, Audible; Suction Failure

  A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED, AND ABNORMAL NOISE WAS HEARD FROM THE ROLLER AREA DURING CATARACT SURGERY. IRRIGATING SOLUTION DIDN'T SEEM TO BE KEEPING UP, AND THE ANTERIOR CHAMBER BECAME UNSTABLE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN CONFIRMING THAT THE PAK WAS REPLACED AND THE SAME ISSUE WAS RECURRED, HOWEVER THE SURGERY WAS PERFORMED AND COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389630 ↗
• MalfunctionMar 21, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ASPIRATION COULD NOT BE PERFORMED DURING ULTRASOUND SURGERY WITH NO HARM TO PATIENT, SITUATION DID NOT IMPROVE EVEN AFTER THE PRODUCT WAS REPLACED FOR TIP AND HANDPIECE, HOWEVER IT ONLY IMPROVED WHEN THE CASSETTE WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583010 ↗
• MalfunctionDec 7, 2022Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED WHEN ASPIRATED DURING US, IT FELT CLOGGED DURING A CATARACT 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 15930745 ↗
• MalfunctionSep 23, 2022Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO POWER TO SCULPT THE NUCLEUS DURING A CATARACT SURGERY (WITH IOL IMPLANT). THE SURGERY WAS COMPLETED AFTER THE CASSETTE AND THE HANDPIECE WERE REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470079 ↗
• MalfunctionMay 8, 2022Particulates; Particulates

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY METALLIC POWDER-LIKE SUBSTANCE WAS LEFT ON THE IRIS DURING SURGERY. SURGEON SUSPECT FOREIGN OBJECT WAS FROM THE PHACOEMULSIFICATION HANDPIECE, PHACO TIP, SLEEVE, OR PACK. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE FOREIGN MATERIAL AND THE PATIENT IS SCHEDULED FOR OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332431 ↗
• MalfunctionMay 8, 2022Particulates; Particulates

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY METALLIC POWDER-LIKE SUBSTANCE WAS LEFT ON THE IRIS DURING SURGERY. SURGEON SUSPECT FOREIGN OBJECT WAS FROM THE PHACOEMULSIFICATION HANDPIECE, PHACO TIP, SLEEVE, OR PACK. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE FOREIGN MATERIAL AND THE PATIENT IS SCHEDULED FOR OBSERVATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332430 ↗
• MalfunctionApr 21, 2022Suction Failure; Suction Failure

  AN OPHTHALMOLOGIST REPORTED THE VACUUM DID NOT RESPOND DURING A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED TWICE STILL THE VACUUM DID NOT RESPOND. THE PROCEDURE WAS DELAYED FOR TWO HOURS AND THEN DISCONTINUED. THE PATIENT WAS SENT TO ANOTHER CLINIC TO COMPLETE THE PROCEDURE SEVEN DAYS LATER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165769 ↗
• MalfunctionMar 24, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION WAS UNAVAILABLE IN ULTRASOUND (US) PHASE DURING THE PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13884218 ↗
• MalfunctionFeb 16, 2022Material Deformation; Material Deformation

  A PHYSICIAN REPORTED A MICRO SLEEVE WAS DEFORMED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE SAMPLE WAS DISCARDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540082 ↗
• MalfunctionFeb 9, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED NO VACUUM WAS PRESENT IN THE MEMORY TWO PHASE DURING A CATARACT PROCEDURE. THE CASSETTE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497816 ↗
• MalfunctionJan 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THE TUBE WAS FOUND DETACHED FROM A CASSETTE DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13313488 ↗
• MalfunctionJan 19, 2022Suction Problem; Suction Problem

  A PHYSICIAN REPORTED IT WAS DIFFICULT TO ASPIRATE DURING THE ULTRASOUND PHASE OF A CATARACT PROCEDURE. THE THIRD REPLACEMENT PAK WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287955 ↗
• MalfunctionJan 17, 2022Suction Problem; Suction Problem

  A PHYSICIAN REPORTED IT WAS DIFFICULT TO ASPIRATE DURING THE ULTRASOUND PHASE OF A CATARACT PROCEDURE. THE FOURTH REPLACEMENT PAK WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265502 ↗
• MalfunctionJan 10, 2022Suction Problem; Suction Problem

  A PHYSICIAN REPORTED IT WAS DIFFICULT TO ASPIRATE DURING THE ULTRASOUND PHASE OF A VITRECTOMY PROCEDURE. THE THIRD REPLACEMENT PAK WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202484 ↗
• MalfunctionJan 5, 2022Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED CONTINUOUS IRRIGATION DID NOT FLOW DURING A SURGERY. THE SAME DEFECT OCCURRED WITH THREE PAKS. THE SURGERY WAS COMPLETED WITH FOURTH REPLACEMENT PAK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167320 ↗
• MalfunctionSep 24, 2021Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO ASPIRATION DURING A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526207 ↗
• MalfunctionSep 8, 2021Suction Failure; Suction Failure

  A NURSE REPORTED A CASSETTE SUCCESSFULLY PRIMED IN THE THIRD ATTEMPT; HOWEVER, IN THE CHOP MODE DURING A CATARACT PROCEDURE, THE SURGEON STATED THERE WAS NO VACUUM. THE CASSETTE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438756 ↗