Constellation, Ultravit, TotalPlus, Engauge 8065751058Recalls & reported problems

Summary

The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 00380657510580), received between Mar 18, 2021 and Feb 27, 2026 — classified as 1 injury, 214 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (98 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 28, 2025Class IIOpen, Classified

   Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

   Z-2109-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 215 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469221 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268047 ↗
• MalfunctionJan 26, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITREOUS PROBE STOPPED CUTTING MIDWAY AND COULD NOT ASPIRATE DURING VITRECTOMY 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 24175995 ↗
• MalfunctionJan 12, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE PROBE STOPPED CUTTING AND WAS UNABLE TO ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24034243 ↗
• MalfunctionDec 25, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP OF THE VITRECTOMY PROBE WAS DEFORMED AND COULD NOT BE USED BEFORE VITRECTOMY SURGERY THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894537 ↗
• MalfunctionDec 5, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION AND NO CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726035 ↗
• MalfunctionDec 3, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE PROBE HAS NO ASPIRATION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702069 ↗
• MalfunctionNov 17, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569431 ↗
• MalfunctionNov 5, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE PROBE STOPPED CUTTING AND ASPIRATION WAS WEAK DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23473757 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS NORMAL. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365584 ↗
• MalfunctionOct 16, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT THE AIR AND FLUID EXCHANGE WAS FAILED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308290 ↗
• MalfunctionAug 14, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT CUTTING WAS TERMINATED MIDWAY AND ASPIRATION WAS WEAK DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806274 ↗
• MalfunctionJul 24, 2025Failure to Cut; Failure to Cut

  A CUSTOMER VIA GOVERNMENT AGENCY REPORTED PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE NEW VITRECTOMY PROBE. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22584313 ↗
• MalfunctionJul 23, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING WAS TERMINATED MIDWAY AND ASPIRATION WAS WEAK DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573913 ↗
• MalfunctionJul 10, 2025Leak/Splash; Leak/Splash

  A PHYSICIAN REPORTED THAT CASSETTE OCCURRED LEAKAGE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466550 ↗
• MalfunctionJul 7, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT THE VITREOUS BODY DURING VITRECTOMY SURGERY. THE ASPIRATION WAS NORMAL. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409366 ↗
• MalfunctionJul 4, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED THAT PROBE STOPPED CUTTING AND ASPIRATION WAS WEAK DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY CHANGING A NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402414 ↗
• MalfunctionJun 24, 2025Failure to Cut; Failure to Cut

  THE NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22313491 ↗
• MalfunctionJun 19, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT VITRECTOMY PROBE WAS FAILED TO CUT AND HAS WEAK ASPIRATION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292147 ↗
• MalfunctionJun 18, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT, AND THE ASPIRATION FUNCTION WAS INTERMITTENT DURING THE VITRECTOMY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22275766 ↗
• MalfunctionJun 4, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY CHANGING A NEW PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22140371 ↗
• MalfunctionJun 4, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY CHANGING A NEW PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22139541 ↗
• MalfunctionJun 3, 2025Air/Gas in Device; Air/Gas in Device

  THE PHYSICIAN REPORTED THAT THE INFUSION HEAD WAS INSERTED AND BUBBLES CONTINUOUSLY APPEARED IN THE INFUSION HEAD. DESPITE MULTIPLE ATTEMPTS TO DRAIN DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE INFUSION HEAD. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22130123 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THAT THE INTAKE TUBING OF THE GLASS CUTTING HEAD FELL OFF FROM THE ROOT OF THE PROBE (ONE WITH THE GRAY WHITE INTERFACE) DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026655 ↗
• MalfunctionMay 6, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT GAS-LIQUID EXCHANGE FUNCTION COULD NOT BE USED NORMALLY DURING PARS PLANA VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968067 ↗