Constellation, Ultravit, TotalPlus, EdgePlus 8065751613Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 00380657516131), received between Mar 24, 2021 and Sep 30, 2026 — classified as 9 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (114 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 28, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Suction Problem; Failure to Cut

  A nurse reported that cutter failed to cut and aspirate during the vitrectomy surgery. The surgery was completed by replacing the cutter. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943686 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A health care professional reported that the vitrectomy probes could not cut during cataract and vitrectomy combination surgery. The procedure was completed on same day by replacement with new ones. There was no information about any patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50934795 ↗
• MalfunctionSep 27, 2026Use of Device Problem

  Patient problems: Insufficient Information

  MAUDE report 50910125 ↗
• MalfunctionSep 25, 2026Fluid/Blood Leak

  A physician reported that the trocar valve leaked during a vitrectomy procedure. The procedure was completed on the same day after the product was replaced with a new trocar valve from a new pack. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895069 ↗
• MalfunctionSep 23, 2026Failure to Cut

  A physician reported that vitrectomy probe could not cut during vitrectomy surgery. The surgery was completed on same day by replacing it with new product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870001 ↗
• MalfunctionSep 23, 2026Leak/Splash

  A non-healthcare professional reported that the cassette exhibited a leak near the bag. The procedure type and other surgery details were unknown. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50868685 ↗
• MalfunctionSep 23, 2026Suction Problem

  A physician reported that this report vitrectomy probe had no aspiration during vitrectomy surgery.The surgery was completed on the same day, but it was unknown how the surgery was completed.There was no information about the patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50865176 ↗
• MalfunctionSep 23, 2026Leak/Splash

  A customer reported via health authority that a leakage was observed in the cassette near the bag at unknown timing of surgery. The procedure type and procedure completion details were unknown, but the kit was replaced with another kit. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50864799 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT LEAK WAS OBSERVED IMMEDIATELY UPON INSERTING THE TROCAR INTO THE EYE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE DEFECTIVE TROCAR WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518757 ↗
• MalfunctionMar 3, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER COULD NOT ASPIRATE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 24493842 ↗
• MalfunctionFeb 19, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY CUTTER HAD FUNCTIONED NORMALLY AT THE BEGINNING AND DID NOT CUT AND ASPIRATE DURING VITRECTOMY SURGERY. HOWEVER, THERE WAS AN EXPULSION OBSERVED THAT WAS NOT DUE TO ASPIRATION, AS ASPIRATION WAS NOT ACTIVE AT THAT TIME. 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 24388361 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  A NURSE REPORTED THAT CUTTER WAS NOT CUTTING BEFORE VITRECTOMY SURGERY. THE CONDITION OF ASPIRATION WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACING THE PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320139 ↗
• MalfunctionFeb 10, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER HAD ASPIRATION FAULT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302093 ↗
• MalfunctionJan 23, 2026Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING PERFORMANCE AND WAS UNABLE TO CUT TISSUE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163924 ↗
• MalfunctionJan 19, 2026Failure to Cut

  A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING EFFICIENCY DURING THE 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 24107197 ↗
• MalfunctionJan 17, 2026Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE HAS POOR CUTTING EFFICIENCY AND DID NOT EFFICIENTLY CUT THE VITREOUS AT 7500 CUTS PER MINUTE (CPM) 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 24105401 ↗
• MalfunctionJan 14, 2026Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT HANDPIECE WAS DULL, IT WAS NOT CUTTING DURING THE VITRECTOMY SURGERY REQUIRING THEM TO OPEN ANOTHER KIT TO CONTINUE THE SURGERY. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24064819 ↗
• MalfunctionJan 7, 2026Dull, Blunt

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE TROCAR WAS HARD TO INSERT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY USING ANOTHER TROCAR FROM THE NEW PACK. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988961 ↗
• MalfunctionJan 6, 2026Suction Problem

  A CUSTOMER REPORTED THAT THERE WAS A PRESSURE PROBLEM WITH ERROR CODE. THE PROCEDURE TYPE AND TIMING OF THE EVENT WERE UNKNOWN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY CHANGING PAK. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975323 ↗
• MalfunctionJan 6, 2026Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE UNABLE TO CUT AND ASPIRATE DURING 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 23971081 ↗
• MalfunctionDec 26, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT AND THE CUTTING EFFICIENCY WAS LOW DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897027 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT CUTTER HEAD DID NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689684 ↗
• MalfunctionDec 1, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT THE CANNULA WAS FOUND TO BE OBSTRUCTED FROM THE FACTORY, CAUSING PROBLEMS (UNSPECIFIED) DURING VITRECTOMY PROCEDURE. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT CANNULA WAS FOUND TO BE OBSTRUCTED DURING CALIBRATION FOR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER INFUSION CANNULA. THERE WAS NO PATIENT CONTACT WITH NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677649 ↗
• MalfunctionNov 26, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING 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 23655344 ↗
• MalfunctionNov 24, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT INCOMPLETE CLOSURE OF THE PROBE DURING 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 23628861 ↗