Constellation, Ultravit, TotalPlus, Engauge 8065751077Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 00380657510771), received between Mar 2, 2021 and Jan 14, 2026 — classified as 1 injury, 161 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (68 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 162 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AFTER INSERTING THE VIT PROBE INTO THE EYE, INTERMITTENT INCOMPLETE CUTTING WAS OBSERVED. THE VIT PROBE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065117 ↗
• MalfunctionJan 13, 2026Failure to Cut; Air/Gas in Device

  A NURSE REPORTED THAT THE PROBE SPIT BUBBLES AND THE CUTTER OF THE PROBE COULD NOT BE CLOSED AFTER OPENED, MAKING IT IMPOSSIBLE TO COMPLETE THE 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 24051981 ↗
• MalfunctionJan 12, 2026Failure to Cut

  A CUSTOMER REPORTED THAT PROBE COULD NOT CUT HALFWAY AND ASPIRATION WAS GOOD DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING WITH PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044915 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE WAS UNABLE TO CUT PROPERLY DURING CATARACT AND VITRECTOMY COMBINATION 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 23755429 ↗
• MalfunctionDec 4, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  A NURSE REPORTED THAT PROBE WAS BUBBLING AND NO ASPIRATION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714114 ↗
• MalfunctionNov 24, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE COULD NOT CUT NORMALLY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628529 ↗
• MalfunctionNov 7, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD CUT BUT ASPIRATION WAS ABNORMAL BEFORE 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 23494540 ↗
• MalfunctionNov 5, 2025Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FINE BUBBLES IN ASPIRATION LINE 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 23475602 ↗
• MalfunctionSep 2, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device

  A NURSE REPORTED THAT THE VITRECTOMY PROBE SPAT BUBBLES, THAT WERE FINE, CONTINUOUS AND LONG STRANDS DURING VITRECTOMY SURGERY. ALSO, VERY FEW BUBBLES WERE SEEN IN ASPIRATION LINE. 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 22935913 ↗
• MalfunctionSep 2, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD NO ASPIRATION. AND THE CUTTING WAS NORMAL BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933138 ↗
• MalfunctionSep 2, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING FUNCTION BEFORE 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 22931604 ↗
• MalfunctionAug 19, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED PROBE HAD NO CUTTING BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH NEW PAK. THERE WAS NO REPORT OF IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22840021 ↗
• MalfunctionAug 8, 2025Material Separation; Material Separation

  THE NURSE REPORTED THAT TUBING FAILED TO CONNECT TO THE HANDPIECE, THE TUBING BECAME DETACHED DURING THE CATARACT/VITRECTOMY COMBINATION 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 22747522 ↗
• MalfunctionJul 25, 2025Leak/Splash; Leak/Splash

  A NURSE REPORTED THAT THE CASSETTE LEAKAGE OCCURRED BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607461 ↗
• MalfunctionJul 8, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE TUBING BROKE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434377 ↗
• MalfunctionJun 30, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT WHEN INSTALLING THE PRODUCT MACHINE WAS ALARMED AND ALSO FOUND THAT THE RUBBER SHEET AT THE BACK OF THE SURGICAL PACK WAS LOOSE 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 22355386 ↗
• MalfunctionJun 17, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE PIPELINE WAS BROKEN DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH A NEW ONE. THERE WAS NO INFORMATION ABOUT ANY IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22218819 ↗
• MalfunctionJun 16, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT BUT ASPIRATION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209846 ↗
• MalfunctionJun 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE AIR/FLUID EXCHANGE FAILED BEFORE 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 22194025 ↗
• MalfunctionMay 28, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION AND COULD NOT WORK PROPERLY BEFORE THE VITRECTOMY SURGERY. THE CUTTING CONDITION WAS NORMAL. THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093851 ↗
• MalfunctionMay 15, 2025Failure to Cut; Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY THAT VITRECTOMY PROBE HAD POOR CUTTING PERFORMANCE, RESULTING IN POOR MAINTENANCE OF INTRAOCULAR PRESSURE PROLONGING THE SURGICAL TIME DURING POSTERIOR VITRECTOMY SURGERY FOR THE TREATMENT OF PROLIFERATIVE VITREORETINOPATHY, MACULAR MEMBRANE. THE SURGERY WAS SUCCESSFULLY COMPLETED IN THE END AFTER REPLACEMENT OF THE PACKAGE. THERE WAS NO INFORMATION ABOUT ANY PATIENT IMPACT. THIS REPORT PERTAINS TO VITRECTOMY PROBE INVOLVED IN REPORTED EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 22025749 ↗
• MalfunctionMay 5, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE WAS INSERTED INTO THE EYE, IT WAS FOUND THAT IT COULD NOT PERFORM CUTTING, AND ONLY ASPIRATION WAS POSSIBLE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE PROBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960682 ↗
• MalfunctionApr 29, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD NO CUTTING COULD NOT CUT THE VITREOUS BODY DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924909 ↗
• MalfunctionApr 18, 2025Disconnection; Disconnection

  A NURSE REPORTED THAT THERE WAS A JAM BETWEEN THE PROBE AND THE CANNULA AND CANNULA WAS PULLED OUT OF THE EYE BEFORE 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 21867378 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  A NURSE REPORTED THAT THE CASSETTE LEAKED DURING VITRECTOMY SURGERY, MADE IT IMPOSSIBLE TO COMPLETE THE 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 21856783 ↗