23 GA ULTRAVIT 8065751561Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657515615), received between May 22, 2023 and Dec 29, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 29, 2025Suction Problem; Suction Problem

  AN OPHTHALMIC SURGEON REPORTED THAT TWO PRODUCTS THAT COULD NOT ASPIRATE AT ALL. THE SECOND ONE WAS INITIALLY UNABLE TO ASPIRATE BUT AFTER A WHILE IT WAS ABLE TO ASPIRATE DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. 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 23905368 ↗
• MalfunctionOct 24, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING AND ASPIRATION FAILURE OF THE PROBE OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381275 ↗
• MalfunctionMar 13, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ANTERIOR VITRECTOMY CUTTER COULD NOT ASPIRATE DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE PRODUCT WAS REPLACED WITH ANOTHER ONE WITH THE SAME LOT NUMBER, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596470 ↗
• MalfunctionFeb 3, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OF THE PROBE OCCURRED DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21291881 ↗
• MalfunctionDec 6, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION DID NOT WORK AND THE CONNECTOR WAS DEFORMED DURING CALIBRATION. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACED WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20861998 ↗
• MalfunctionOct 25, 2024Suction Failure; Suction Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CUTTER HAD NO ASPIRATION DURING CALIBRATION STAGE OF CATARACT [WITHOUT INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531485 ↗
• MalfunctionAug 28, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING CATARACT SURGERY BUT BEFORE THE USE ON A PATIENT. IT WAS UNKNOWN IF THE DEFECT OCCURRED DURING ULTRA SONIC MODE OR IRRIGATION/ASPIRATION MODE. 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 20083730 ↗
• MalfunctionJun 10, 2024Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496277 ↗
• MalfunctionApr 19, 2024Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED THAT PRODUCT GOT CLOGGED DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141576 ↗
• MalfunctionDec 4, 2023Suction Failure; Suction Failure

  THE PHYSICIAN REPORTED THAT ASPIRATION FAILURE OF THE PROBE OCCURRED DURING THE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254170 ↗
• MalfunctionOct 13, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF THE PROBE OCCURRED DURING VITRECTOMY SURGERY. THE CONDITION OF ASPIRATION WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928909 ↗
• MalfunctionMay 22, 2023Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE PROBE ASPIRATED BUT FAILED TO CUT THE VITREOUS DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER PACK. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974248 ↗