Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752436Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00380657524365), received between Jul 8, 2021 and Sep 30, 2026 — classified as 9 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (55 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-2108-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut

  A healthcare professional reported that cutter did not cut during the vitrectomy surgery. The aspiration condition was normal. The other surgery details and patient impact details were unknown.Additional information requested and received that the surgery was completed by replacing the cutter. Theare was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943687 ↗
• MalfunctionMar 6, 2026Failure to Cut

  A NURSE REPORTED THAT CUTTING FAILURE OF THE PROBE OCCURRED DURING THE VITRECTOMY SURGERY. FIVE THOUSAND CUTS PER MINUTE WAS NOT COMMENTED IF TRIED AND VACUUM OR ASPIRATION APPEARED NORMAL THROUGHOUT THE SURGERY. MAXIMUM CUT RATE AND MAXIMUM VACUUM WERE USED AND NO ERROR MESSAGE WAS DISPLAYED ON THE MACHINE. 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 24530579 ↗
• MalfunctionFeb 25, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CUT RATE WAS NORMAL IN THE BEGINNING AFTER A WHILE CUTTING WAS REDUCED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY USING NEW PAK. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ASPIRATION WAS QUITE NOT NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440196 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A NURSE REPORTED THAT THE CUTTER/PROBE WAS NOT FUNCTIONING EFFICIENTLY (CUTTING ISSUE) EVEN REDUCED THE 5000 CUTS PER MINUTE (CPM) DURING THE VITRECTOMY SURGERY. THE OTHER SURGERY DETAILS WERE UNKNOWN. 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 24386480 ↗
• MalfunctionFeb 16, 2026Failure to Cut

  THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24345752 ↗
• MalfunctionFeb 11, 2026Obstruction of Flow

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE INFUSION HEAD WAS NOT UNOBSTRUCTED (BLOCKED) BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE INFUSION CANNULA WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312895 ↗
• MalfunctionFeb 10, 2026Failure to Cut

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER STOPPED WORKING PROPERLY AND EVEN AFTER REDUCING THE CUT RATE THERE WAS NO IMPROVEMENT DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24302465 ↗
• MalfunctionFeb 4, 2026Obstruction of Flow

  A PHARMACIST REPORTED THAT THE INFUSION LINE WAS NOT WORKING, APPEARED TO BE BLOCKED RIGHT FROM THE START (BEFORE) VITREO RETINAL SURGERY. A NEW CASSETTE WAS OPENED TO RETRIEVE THE INFUSION LINE AND TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256259 ↗
• MalfunctionFeb 2, 2026Failure to Cut

  A NURSE REPORTED THAT PROBE COULD NOT CUT 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 24232452 ↗
• MalfunctionJan 13, 2026Failure to Cut

  A CUSTOMER REPORTED THAT THE PRODUCT (PROBE) COULD NOT CUT BEFORE INTRA OCULAR LENS IMPLANTATION. IT WAS CHANGE TO NEW ONE AND PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053240 ↗
• MalfunctionJan 8, 2026Failure to Cut

  A CUSTOMER REPORTED CUTTER WOULDN¿T CUT AT AN UNKNOWN TIMING. THE PROCEDURE TYPE AND SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24001245 ↗
• InjuryJan 6, 2026Failure to Cut

  A CUSTOMER REPORTED THAT DURING A PARS PLANA VITRECTOMY PROCEDURE ON THE LEFT EYE, A VITRECTOMY PROBE STOPPED CUTTING AND CONTINUED SUCTION, CAUSING A RETINAL DETACHMENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE CUTTER. THE PATIENT¿S CURRENT CONDITION WAS UNKNOWN. THIS REPORT PERTAINED TO THE VITRECTOMY PROBE INVOLVED IN THE REPORTED EVENT.

  Patient problems: Retinal Detachment

  MAUDE report 23973595 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT THE CUTTER STOPPED CUTTING DURING PARS PLANAR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS A CONTACT WITH THE PATIENT BUT NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO VITRECTOMY CUTTER INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922624 ↗
• MalfunctionDec 26, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A CUSTOMER REPORTED THAT AFTER REDUCING THE CUT RATE, THE CUTTER WAS FUNCTIONING AND THERE WAS ABNORMAL NOISE FROM THE CUTTER DURING VITRECTOMY SURGERY FOR THE LEFT EYE. THE SURGERY WAS COMPLETED BY REDUCING THE CUT RATE. THERE WAS PATIENT CONTACT, BUT NO IMPACT OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901293 ↗
• MalfunctionDec 25, 2025Failure to Cut; Failure to Cut

  NEW INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT LEFT EYE WAS INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892352 ↗
• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER DID NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS CONTACT WITH THE PATIENT BUT NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887770 ↗
• MalfunctionDec 18, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBES THAT STOPPED CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER PROBE. THERE WAS A PATIENT CONTACT BUT NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836227 ↗
• InjuryDec 10, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION INDICATED THAT THE PREVIOUSLY ABORTED PROCEDURE WAS EVENTUALLY COMPLETED, HOWEVER, THE EXACT DATE AND TIME OF COMPLETION REMAIN UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23765813 ↗
• InjuryDec 10, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION INDICATED THAT THE PREVIOUSLY ABORTED PROCEDURE WAS EVENTUALLY COMPLETED, HOWEVER, THE EXACT DATE AND TIME OF COMPLETION REMAIN UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23765810 ↗
• InjuryDec 10, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION INDICATED THAT THE PREVIOUSLY ABORTED PROCEDURE WAS EVENTUALLY COMPLETED, HOWEVER, THE EXACT DATE AND TIME OF COMPLETION REMAIN UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23765806 ↗
• MalfunctionNov 5, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER FAILED TO CUT IN AN UNKNOWN TIMING. THE PROCEDURE TYPE WAS UNKNOWN. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23477680 ↗
• MalfunctionOct 27, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS PATIENT CONTACT, BUT NO IMPACT TO THE LEFT EYE OF THE FEMALE ADULT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390504 ↗
• MalfunctionOct 16, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY CUTTER WAS DELIVERING POOR CUTTING SPEED IN BETWEEN THE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS PATIENT CONTACT WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319898 ↗
• MalfunctionOct 16, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT ALTHOUGH THE PRIMING OF THE PAK WAS NORMAL, AFTER A FEW MINUTES INTO THE PARS PLANA VITRECTOMY (PPV) SURGERY IN THE RIGHT EYE OF A FEMALE ADULT PATIENT, VITRECTOMY CUTTER/PROBE WAS NOT WORKING EFFICIENTLY. RE-PRIMING WAS SUCCESSFUL BUT THE VITRECTOR WAS CUTTING AND VACUUMING BUT NOT PERFORMING AS EXPECTED. THE MACHINE WAS REPLACED WITH A DIFFERENT MACHINE AND A NEW PACK WAS OPENED AND USED BUT THE PERFORMANCE ISSUE PERSISTED. THE VITRECTOR CUTTING AND VACUUM FUNCTIONS REMAINED SUBOPTIMAL THROUGHOUT THE EARLY PART OF THE PROCEDURE. THE SURGEON CONFIRMED THAT THE CUTTER BEGAN TO FUNCTION UP TO SPEED ONLY DURING THE LATTER HALF OF THE PROCEDURE, PRIOR TO CLOSURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT. ADDITIONALLY, IT WAS CONFIRMED THAT THERE WAS ONLY POOR CUTTING AND ASPIRATION WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308418 ↗
• MalfunctionOct 15, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE EVENT OCCURRED BEFORE VITRECTOMY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23297947 ↗