Alcon, Infiniti, Intrepid, ABS 8065752081Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380657520817), received between Apr 6, 2021 and Nov 18, 2024 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (12 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.

• MalfunctionNov 18, 2024Suction Failure; Suction Failure

  IT WAS DETERMINED THAT THE INFORMATION PROVIDED FOR THIS EVENT NO VACUUM WAS CREATED DOES NOT REPRESENT A REPORTABLE DEVICE MALFUNCTION AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY. THE INITIAL REPORT WAS SUBMITTED IN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703865 ↗
• MalfunctionAug 2, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THAT THE EQUIPMENT DID NOT PERFORM VACUUM DURING THE CATARACT [WITHOUT INTRAOCULAR (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446321 ↗
• MalfunctionJul 17, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THERE WAS NO VACUUM OCCURRED DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE. THERE WAS PATIENT CONTACT BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332614 ↗
• MalfunctionJul 5, 2023Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE VACUUM FAILURE WAS OCCURRED DURING THE 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 17254233 ↗
• MalfunctionMay 18, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A NURSE REPORTED THAT THE CONNECTION AT THE INTERFACE WITH THE HANDLE WAS LOOSE DURING CATARACT SURGERY, THE PROCEDURE WAS COMPLETED BY REPLACING THE PAK WITH NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952663 ↗
• MalfunctionMar 2, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THAT THERE WAS NO VACUUM DURING HALF WAY OF THE 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 16469995 ↗
• MalfunctionMar 1, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THAT THERE WAS NO VACUUM DURING HALF WAY OF CATARACT SURGERY. SURGERY WAS COMPLETED WITH NO HARM PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458253 ↗
• MalfunctionFeb 27, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO VACUUM DURING HALF WAY OF CATARACT SURGERY. SURGERY WAS COMPLETED WITH PATIENT CONTACT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442344 ↗
• MalfunctionFeb 27, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO VACUUM DURING HALF WAY OF CATARACT SURGERY. SURGERY WAS COMPLETED WITH PATIENT CONTACT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442343 ↗
• MalfunctionFeb 27, 2023Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO VACUUM DURING HALF WAY OF CATARACT SURGERY. SURGERY WAS COMPLETED WITH PATIENT CONTACT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442335 ↗
• MalfunctionDec 16, 2021Suction Failure; Suction Failure

  A CUSTOMER REPORTED DURING THE CATARACT PROCEDURE THE HANDPIECE EMULSIFIED THE LENS NORMALLY BUT COULD NOT ASPIRATE. BOTH HANDPIECE AND THE TIP COULD NOT ASPIRATE. WITH WARNING OF OCCLUSION, IT WAS THOUGHT OCCLUSION WAS FROM THE HANDPIECE THEREFORE IT WAS FLUSHED WITH THE SOLUTION BUT STILL ASPIRATION COULD NOT BE PERFORMED. THE HANDPIECE TO A NEW ONE BUT STILL COULD NOT ASPIRATE. THEN THE FLUIDICS MANAGEMENT SYSTEM (FMS) WAS CHANGED TO A NEW FMS AND LATER COULD PROCEED WITH THE ASPIRATION AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015808 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION FOLLOWING A CATARACT PROCEDURE. A VITREOUS TAP WAS PERFORMED AND NO ORGANISMS WAS IDENTIFIED BECAUSE THE PATIENT WAS TREATED WITH ANTIBIOTICS PRIOR TAKING THE VITREOUS TAP. ADDITIONAL INFORMATION WAS REQUESTED. THIS IS THE SEVENTH OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12813231 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION FOLLOWING A CATARACT PROCEDURE. A VITREOUS TAP WAS PERFORMED AND NO ORGANISMS WAS IDENTIFIED BECAUSE THE PATIENT WAS TREATED WITH ANTIBIOTICS PRIOR TAKING THE VITREOUS TAP. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER. THIS IS THE SIXTH OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12813230 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION FOLLOWING A CATARACT PROCEDURE. A VITREOUS TAP WAS PERFORMED AND NO ORGANISMS WAS IDENTIFIED BECAUSE THE PATIENT WAS TREATED WITH ANTIBIOTICS PRIOR TAKING THE VITREOUS TAP. ADDITIONAL INFORMATION WAS REQUESTED. THIS IS THE EIGHT OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12813088 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION FOLLOWING A CATARACT PROCEDURE. THE PHACOEMULSIFICATION TUBING SHOWED SOME DOUBTFUL GROWTH HOWEVER THE PATIENT¿S VITREOUS TAP WAS NEGATIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS AND THE CONDITION WAS IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED. THIS IS THE THIRD OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12813087 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION FOLLOWING A CATARACT PROCEDURE. THE PHACOEMULSIFICATION TUBING SHOWED SOME DOUBTFUL GROWTH HOWEVER THE PATIENT¿S VITREOUS TAP WAS NEGATIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS AND THE CONDITION WAS IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED. THIS IS THE FOURTH OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12810556 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION FOLLOWING A CATARACT PROCEDURE. THE PHACOEMULSIFICATION TUBING SHOWED SOME DOUBTFUL GROWTH HOWEVER THE PATIENT¿S VITREOUS TAP WAS NEGATIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS AND THE CONDITION WAS IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS IS THE FIFTH OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12810522 ↗
• MalfunctionNov 8, 2021Suction Failure; Suction Failure

  A NURSE REPORTED THE SUCTION WAS NOT WORKING DURING THE PHACOEMULSIFICATION MODE OF A CATARACT PROCEDURE. THE CASSETTE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771537 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS THE FIRST OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Bacterial Infection; Corneal Edema; Endophthalmitis; Loss of Vision; Uveitis

  MAUDE report 12739839 ↗
• MalfunctionNov 2, 2021Suction Failure; Suction Failure

  A NURSE REPORTED THERE WAS NO VACUUM DURING CATARACT 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 12736110 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS THE SECOND OF EIGHT REPORTS FOR THIS SURGEON.

  Patient problems: Loss of Vision; Unspecified Infection

  MAUDE report 12703941 ↗
• MalfunctionJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT IRRIGATION LUER WAS COMING OUT OF THE PHACO HANDPIECE WHICH CAUSED CHAMBER COLLAPSE AND INSTABILITY DURING CATARACT SURGERY. THE PRODUCT WAS REPLACED AD THE SURGERY A COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120514 ↗
• MalfunctionJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT IRRIGATION LUER WAS COMING OUT OF THE PHACO HANDPIECE WHICH CAUSED CHAMBER COLLAPSE AND INSTABILITY DURING CATARACT SURGERY. THE PRODUCT WAS REPLACED AD THE SURGERY A COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120512 ↗
• MalfunctionJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT IRRIGATION LUER WAS COMING OUT OF THE PHACO HANDPIECE WHICH CAUSED CHAMBER COLLAPSE AND INSTABILITY DURING CATARACT SURGERY. THE PRODUCT WAS REPLACED AD THE SURGERY A COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120510 ↗
• MalfunctionMay 20, 2021Filling Problem; Filling Problem

  A PHYSICIAN REPORTED THE FLUID WAS NOT FILLING DURING A CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857027 ↗