Alcon, Infiniti, Intrepid 8065752082Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657520824), received between May 24, 2021 and Jul 17, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  A PHYSICIAN REPORTED THAT AN ABNORMAL SOUND WAS HEARD, AND ASPIRATION FAILURE OCCURRED DURING THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332420 ↗
• MalfunctionApr 12, 2023Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ADVISORY CODE WAS DISPLAYED AND NO ASPIRATION WAS APPLIED AT ALL DURING THE PHACOEMULSIFICATION MODE OF 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 16729083 ↗
• MalfunctionDec 29, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED ASPIRATION FAILURE OCCURRED DURING CATARACT SURGERY. ASPIRATION PRESSURE DID NOT INCREASE. 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 16068551 ↗
• MalfunctionOct 7, 2022Device Displays Incorrect Message; Suction Failure; Device Displays Incorrect Message; Suction Failure

  A PHYSICIAN REPORTED THE ASPIRATION STOPPED WORKING IN THE MIDDLE OF ULTRASOUND (US) STEP OF A CATARACT SURGERY. AN ADVISORY MESSAGE "PLEASE REPLACE THE PAK" WAS DISPLAYED. THE SURGERY WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561770 ↗
• MalfunctionAug 29, 2022Suction Failure; Suction Failure

  AN OPHTHALMIC SURGEON REPORTED ASPIRATION FAILURE OCCURRED DURING CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PAK WITH ANOTHER ONE. AFTER REPLACEMENT, THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309696 ↗
• MalfunctionMay 5, 2022Inability to Irrigate; Inability to Irrigate

  AN OPHTHALMIC SURGEON REPORTED 169 WAS DISPLAYED AND IRRIGATION FAILURE DURING A CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287869 ↗
• MalfunctionApr 7, 2022Inability to Irrigate; No Flow; Inability to Irrigate; No Flow

  AN OPHTHALMIC SURGEON REPORTED IRRIGATION FAILURE AND THE SOLUTION DID NOT COME OUT DURING A CATARACT PROCEDURE. THE FOURTH REPLACEMENT PRODUCT WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043229 ↗
• MalfunctionApr 7, 2022Inability to Irrigate; No Flow; Inability to Irrigate; No Flow

  AN OPHTHALMIC SURGEON REPORTED IRRIGATION FAILURE AND THE SOLUTION DID NOT COME OUT DURING A CATARACT PROCEDURE. THE FOURTH REPLACEMENT PRODUCT WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043226 ↗
• MalfunctionMar 30, 2022Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THE IRRIGATION SOLUTION DID NOT COME OUT SEVERAL TIMES DURING THE PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM. SAMPLE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952070 ↗
• InjuryNov 22, 2021Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THOUGH THEY HAD SEVERAL IRRIGATION ERRORS, THE CASSETTE PASSED PRIMING; HOWEVER, DURING ULTRASOUND OF THE NUCLEUS, THE IRRIGATION STOPPED AND THE ANTERIOR CHAMBER IN PATIENT¿S RIGHT EYE COLLAPSED WITH ZONULE DEHISCENCE DURING THE CATARACT PROCEDURE. AN ANTERIOR VITRECTOR WAS UTILIZED AND THE PROCEDURE WAS DISCONTINUED MIDWAY. THE PATIENT WAS SCHEDULED FOR A REOPERATION AT ANOTHER FACILITY AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON WHO INDICATED ONE WEEK LATER, A RE-OPERATION WAS PERFORMED WITH SCLERAL FIXATION OF AN INTRAOCULAR LENS (IOL) AND IT WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Eye / Vision Problem; Zonular Dehiscence

  MAUDE report 12858492 ↗
• MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED DISCONNECTION OF AN IRRIGATION LINE MULTIPLE TIMES DURING A SURGERY. THE TYPE OF SURGERY WAS UNKNOWN. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567289 ↗
• MalfunctionMay 24, 2021Inability to Irrigate; Inability to Irrigate

  A PHYSICIAN REPORTED THAT THE IRRIGATION FAILURE OCCURRED DURING A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870017 ↗