CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753109Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00380657531097), received between May 13, 2021 and Sep 23, 2026 — classified as 1 injury, 222 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (152 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-2108-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Suction Problem

  A non-healthcare professional reported that the vitrector reduced aspiration performance during the vitrectomy surgery. The surgery was completed even though the vitrector had reduced aspiration. There was no impact on the patient.This report pertains to the suspect of probe.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865175 ↗
• MalfunctionSep 22, 2026Suction Problem

  A physician reported that the aspiration failure of the cutter occurred during the surgery. The procedural type was unknown. 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 50850986 ↗
• MalfunctionApr 17, 2026Suction Problem; Failure to Cut; Air/Gas in Device

  A CUSTOMER REPORTED THAT BOTH CUTTING AND ASPIRATION WERE AFFECTED, SURGEON COULD NOT SEE WELL INSIDE THE EYE THAT AFFECT CUTTING EFFICIENCY, BUBBLES GENERATED WHEN CUTTER OFF DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24912707 ↗
• MalfunctionMar 2, 2026Failure to Cut

  A CUSTOMER REPORTED THAT THE VITRECTOMY TIP FAILED DURING CUTTING, PREVENTING THE PROCEDURE FROM BEING PERFORMED CORRECTLY DURING VITRECTOMY SURGERY. THE VITRECTOMY TIP WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24479082 ↗
• MalfunctionJan 21, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING OF CUTTER WAS POOR DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129923 ↗
• MalfunctionJan 21, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF CUTTER OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129359 ↗
• MalfunctionJan 20, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT CASSETTE IRRIGATION FAILURE OCCURRED, AND IRRIGATION AMOUNT WAS LOW DURING THE SURGERY. THE SURGERY TYPE WAS UNKNOWN. 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 24114240 ↗
• MalfunctionJan 12, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF CUTTER OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 24037599 ↗
• MalfunctionJan 12, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITREOUS CUTTER DID NOT ACTUATE 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 24034145 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE HAD A LITTLE NOTCH IN THE METAL SHAFT AND WOULD NOT GO INTO THE TROCAR DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 24000458 ↗
• MalfunctionJan 6, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER MOVEMENT WAS UNSTABLE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 23971354 ↗
• MalfunctionJan 5, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD POOR 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 23955893 ↗
• MalfunctionJan 2, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE ACTUATION PROBLEM OF CUTTER OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 23941351 ↗
• MalfunctionDec 31, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER DID NOT ROTATE DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THE CONDITION OF ASPIRATION AND ACTUATION WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23933434 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY WITH SAME PRODUCT REPLACEMENT. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920222 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER MOVEMENT HAD WORSENED DURING BIT CUTTER PROCESSING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH A REPLACEMENT. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920221 ↗
• MalfunctionDec 22, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING DURING THE CALIBRATION STEP OF SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THE PRODUCT WAS NOT CONTACTED WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861865 ↗
• MalfunctionDec 16, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER DID NOT ACTUATE DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23813682 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTING FAILURE OF THE PROBE OCCURRED AND IT STOPPED WORKING DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755571 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE ACTUATION FAILURE OF CUTTER OCCURRED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO INFORMATION REPORTED ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23754747 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT ACTUATE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23754745 ↗
• MalfunctionDec 8, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE ACTUATION FAILURE OF CUTTER OCCURRED DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE CUTTER. THE PRODUCT WAS CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741422 ↗
• MalfunctionDec 5, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER WAS NOT ACTUATED DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE CONDITION OF ASPIRATION 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 23725173 ↗
• MalfunctionDec 2, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF THE PROBE OCCURRED 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 23691056 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF THE PROBE OCCURRED 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 23682017 ↗