Alcon, Infiniti, UltraVit 8065751196Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657511969), received between Feb 3, 2022 and May 17, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING FAILURE OF THE PROBE OCCURRED BEFORE CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT (IOL)). THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH NEW PRODUCT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19338370 ↗
• MalfunctionApr 30, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE FAILURE OF PRODUCT IN THE CUT AND IT WAS ALSO STUCK BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215769 ↗
• MalfunctionDec 5, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING AND ACTUATION FAILURE OF THE CUTTER DURING 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 18271973 ↗
• MalfunctionDec 5, 2023Failure to Cut; Suction Failure; Failure to Cut; Suction Failure

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO CUTTING PERFORMANCE AND NO ASPIRATION BEFORE VITRECTOMY 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 18265108 ↗
• MalfunctionDec 5, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER DID NOT CUT PROPERLY DURING SURGERY. THE PROCEDURE WAS COMPLETED AFTER THE CUTTER WAS REPLACED WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264358 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOREIGN MATERIAL WAS FOUND AT TIP OF THE PROBE.ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT, POSTERIOR CAPSULAR RUPTURE (PCR) OCCURRED DURING THE CATARACT SURGERY, BUT NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT.

  Patient problems: Rupture

  MAUDE report 17371874 ↗
• MalfunctionMay 25, 2023Complete Blockage; Failure to Cut; Complete Blockage; Failure to Cut

  A CUSTOMER REPORTED THAT THE VITRECTOMY PROBE NOT WORKING, IT HAD ONE OF THE HOSES BLOCKED AND DOES NOT CUT DURING VITRECTOMY SURGERY. ASPIRATION STATUS AND PATIENT HARM WERE NOT REPORTED. THE SURGERY TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002865 ↗
• MalfunctionAug 12, 2022Failure to Cut; Failure to Cut

  A PHARMACIST REPORTED VITRECTOME KNIFE DID NOT WORK, DID NOT CUT DURING VITRECTOMY PROCEDURE. PROCEDURE WAS COMPLETED BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218424 ↗
• MalfunctionFeb 3, 2022Inability to Irrigate; Inability to Irrigate

  A NURSE REPORTED WATER DIDN'T COME OUT FROM THE IRRIGATION LINE DURING A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441124 ↗