Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752449Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00380657524495), received between Apr 19, 2021 and Sep 25, 2026 — classified as 3 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (39 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Cut

  A physician reported that vitrectomy probe gradually lost cutting during vitrectomy surgery. The surgery was completed on the same day after replacing the product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896375 ↗
• MalfunctionSep 24, 2026Failure to Cut

  A physician reported that the vitrectomy probe gradually lost 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 50880206 ↗
• MalfunctionSep 23, 2026Failure to Cut

  A physician reported that the vitrectomy probe gradually lost cutting during vitrectomy surgery. The surgery was completed on same day after replacing the same product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865540 ↗
• MalfunctionMar 2, 2026Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE STOPPED CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE VITRECTOR WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480304 ↗
• MalfunctionFeb 20, 2026Failure to Cut

  A NURSE REPORTED THAT CUTTER STOPPED CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH THE VITRECTOM. THERE WAS PATIENT CONTACT BUT NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398988 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOR COULD NOT CUT DURING PARS PLANAR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE VITRECTOR WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265742 ↗
• MalfunctionJan 30, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE ULTRASOUND COULD NOT BE ACTIVATED DURING PHACOEMULSIFICATION, AND THE SYSTEM INDICATED HIGH PRESSURE 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 24220682 ↗
• MalfunctionJan 13, 2026Failure to Cut

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THERE WAS POOR CUTTING AFTER THE PACKAGE CONNECTED TO THE DEVICE DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. A NEW ONE WAS REPLACED TO COMPLETE THE SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24050862 ↗
• MalfunctionDec 29, 2025Dull, Blunt; Dull, Blunt

  A HEALTHCARE PROFESSIONAL REPORTED THAT TROCAR TIP WAS NOT PENETRATING PROPERLY BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23904332 ↗
• MalfunctionDec 26, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT VITREOUS CUTTING WAS NOT EFFECTIVE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION AND VITRECTOMY COMBINATION SURGERY. THE SPEED WAS REDUCED AND TRIED TO COMPLETE THE SURGERY BUT IT DID NOT WORK. THE SURGERY WAS COMPLETED AFTER USING A 25 GAUGE VITRECTOMY CASSETTE FROM A DIFFERENT SERIES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894800 ↗
• MalfunctionDec 22, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT AND COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY PROCESSED ON THE SAME DAY AFTER NEW PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866502 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PACK WITH NEW ONE. THERE WAS NO PATIENT CONTACT AND PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754749 ↗
• MalfunctionNov 28, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT APPROXIMATELY ONE HOUR AFTER THE START OF THE SURGERY, THE VITRECTOMY PROBE BEGAN TO LOSE CUTTING EFFICIENCY DURING VITRECTOMY SURGERY. NO ERROR MESSAGE WAS DISPLAYED ON THE DEVICE. WHEN THIS DROP IN CUTTING EFFICIENCY OCCURRED, THE PROCEDURE WAS NEARING COMPLETION, HENCE THE SURGERY WAS COMPLETED WITH THE SAME PROBE (WITHOUT REPLACEMENT) ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669652 ↗
• MalfunctionNov 19, 2025Suction Problem; Suction Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE HAD FAILED TO ASPIRATE OR VACUUM AT AN UNKNOWN TIMING. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23601184 ↗
• MalfunctionNov 19, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT THE VITRECTOMY PROBE HAD FAILED TO ASPIRATE/VACUUM AT AN UNKNOWN TIMING. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE VITRECTOMY PROBE WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23594275 ↗
• MalfunctionNov 18, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE LOSES CUTTING EFFICIENCY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT NO SYSTEM MESSAGES WERE DISPLAYED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578859 ↗
• MalfunctionNov 18, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE LOSES CUTTING EFFICIENCY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT NO SYSTEM MESSAGES WERE DISPLAYED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578857 ↗
• MalfunctionNov 18, 2025Suction Problem; Suction Problem

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 23578819 ↗
• MalfunctionNov 17, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE LOSES CUTTING EFFICIENCY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23566606 ↗
• MalfunctionNov 17, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE LOSES CUTTING EFFICIENCY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23566602 ↗
• MalfunctionNov 11, 2025Suction Problem; Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE HAD FAILED TO ASPIRATE/VACUUM DURING SURGERY. PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23522390 ↗
• MalfunctionNov 3, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE ASPIRATION FUNCTION WAS NORMAL. 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 23449049 ↗
• MalfunctionOct 31, 2025Suction Problem; Defective Component; Suction Problem; Defective Component

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE HAD ASPIRATION OR VACUUM FAILURE, BUT THE CUTTER WAS FUNCTIONING NORMALLY DURING THE VITRECTOMY SURGERY. THE CONDITION HAD PERSISTED SINCE INITIAL USE AND THEREFORE, IT WAS CONCLUDED THAT THE VITRECTOMY PROBE WAS DAMAGED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23437629 ↗
• MalfunctionOct 24, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY CUTTER BLADE JAMMED. THE SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE VITRECTOMY SURGERY WAS COMPLETED BY REPLACING THE PAK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377688 ↗
• MalfunctionOct 21, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE KNIFE CEASED TO FUNCTION PROPERLY AND STOPPED CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS PATIENT CONTACT BUT NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347016 ↗