CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000096Recalls & reported problems

Summary

The FDA's MAUDE database contains 554 adverse event reports that list this exact device (DI 00380650000965), received between Mar 9, 2021 and Sep 30, 2026 — classified as 11 injuries, 543 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (368 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 554 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949933 ↗
• MalfunctionSep 30, 2026Failure to Cut

  A healthcare professional reported that the vitrector stopped cutting during vitrectomy surgery. In order to continue the operation, the doctor ordered to open another cassette, In total, there were two with the failure and one to be able to complete the surgery. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50943065 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A physician reported actuation problem of the cutter occurred during surgery. The procedure type was unknown. The surgery was completed after replacing it with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929610 ↗
• MalfunctionSep 29, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928546 ↗
• MalfunctionSep 25, 2026Use of Device Problem

  A nurse reported that the cutter was defective at unknown timing of the surgery. The procedure type was unknown. The surgery completed ion same day, but the procedure completion details were unknown. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50898508 ↗
• MalfunctionSep 23, 2026Failure to Cut

  A physician reported that the cutting failure of cutter occurred during surgery during vitrectomy. The surgery was completed on same day, after replacing it with new one. There was a patient contact but no impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864986 ↗
• MalfunctionAug 25, 2026Suction Problem

  A physician reported that during surgery, aspiration failure of irrigation/ aspiration (I/A) occurred. The procedural type was unknown. The surgery was completed on the same day after replacing the product with another one. There was contact with patient but no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436801 ↗
• MalfunctionAug 20, 2026Failure to Cut

  A physician reported that a cutting failure of the probe occurred during surgery. The surgery was completed on the same day after replacing the product with another one. The procedure type was unknown. There was patient contact with the suspect product, but no impact occurred to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50339859 ↗
• MalfunctionAug 10, 2026Suction Problem; Failure to Cut

  A physician reported that the cutter did not aspirate and cut during surgery. The procedure type was unknown. The procedure was completed on same day after replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189566 ↗
• MalfunctionApr 1, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTTER DID NOT ACTUATE DURING THE SURGERY. THE SURGERY TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THE PRODUCT WAS NOT CONTACTED WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757217 ↗
• MalfunctionFeb 20, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT CUTTING PROCEDURE WAS ONLY POSSIBLE WITH CONSTANT INTERRUPTIONS, ASPIRATION WAS LIMITED AND A VACUUM WAS PRESENT, BUT ONLY VERY SLOWLY AND WITH SIGNIFICANTLY REDUCED ASPIRATION POWER DURING THE VITRECTOMY SURGERY. THE DEFECTIVE VITRECTOMY PROBE WAS REPLACED, AND FIVE HYPERVIT BEVEL VITRECTOMY PROBES WERE USED UNTIL THE END OF THE FIRST OPERATION OF THE DAY. THE PATIENT EXPERIENCED IMPAIRMENT DUE TO THE EXTENDED SURGERY AND ANESTHESIA TIME. THE CURRENT PATIENT CONDITION WAS CAPTURED AS RESOLVED SINCE THE REPORTED IMPAIRMENT WAS REFERRING TO EXTENDED SURGERY AND ANESTHESIA TIME, NO ADDITIONAL IMPAIRMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398981 ↗
• MalfunctionFeb 20, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOR STOPPED FUNCTIONING, AN ATTEMPT WAS MADE TO CHECK THE CUTTER, SIGNIFICANTLY REDUCED ASPIRATION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE TUBING, AS WELL AS SLOWED, IMPROPER CUTTER PERFORMANCE DURING VITRECTOMY SURGERY. THE VITRECTOR WAS REPLACED USING AN ADDITIONAL CASSETTE; HOWEVER, THE PROBLEM WITH PROPER CUTTER FUNCTION OCCURRED AGAIN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A SECOND SURGICAL SET WAS OPENED, AND THE CASSETTE TOGETHER WITH THE CUTTER WAS REPLACED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398461 ↗
• MalfunctionFeb 19, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER REDUCED ASPIRATION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE TUBING AND SLOWED DURING THE VITRECTOMY SURGERY. THE CUTTER WAS REPLACED USING AN ADDITIONAL CASSETTE. HOWEVER, THE PROBLEM WITH PROPER CUTTER FUNCTION OCCURRED AGAIN. THE SURGERY WAS COMPLETED ON SAME DAY BY USING THE SECOND CASSETTE TOGETHER WITH THE CUTTER. THE PRODUCT WAS CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386476 ↗
• MalfunctionFeb 16, 2026Failure to Cut

  A CUSTOMER REPORTED THAT PACK FAILED THIS WEEK STOPPED CUTTING THE VITRECTOR, SO THEY DECIDED TO OPEN ANOTHER PACK. AFTER REPLACING IT, EVERYTHING WORKED PERFECTLY DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24343411 ↗
• MalfunctionFeb 12, 2026Suction Problem; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT A SIGNIFICANT REDUCTION OF ASPIRATION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE TUBING, AS WELL AS SLOWED AND IMPROPER CUTTER PERFORMANCE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS PATIENT CONTACT WITH THE PRODUCT, BUT NO IMPACT OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319910 ↗
• MalfunctionFeb 9, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298253 ↗
• MalfunctionFeb 5, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT POOR ACTUATION OF CUTTER WAS CONFIRMED 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 IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265974 ↗
• MalfunctionFeb 5, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CUTTER ACTUATION WAS POOR, AND THE CUTTER COULD NOT ASPIRATE 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 24265319 ↗
• MalfunctionJan 30, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION PROBLEM OF CUTTER OCCURRED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. 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 24219525 ↗
• MalfunctionJan 29, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE CUTTER COULD NOT ASPIRATE 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 24208224 ↗
• MalfunctionJan 14, 2026Infusion or Flow Problem

  AN OPHTHALMIC SURGEON REPORTED THAT THE PRODUCT (CASSETTE) COULD NOT BE USED DUE TO IRRIGATION ERROR DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS PATIENT CONTACT WITH SUSPECT PRODUCT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070032 ↗
• MalfunctionJan 14, 2026Failure to Cut

  A CUSTOMER REPORTED THAT THE VITRECTOMY TIP FAILED DURING CUTTING OF THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING WITH A NEW TIP. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24065487 ↗
• MalfunctionJan 12, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THERE WAS ACTUATION ISSUE OF THE CUTTER DURING SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. 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 24034008 ↗
• MalfunctionJan 12, 2026Break

  A PHYSICIAN REPORTED THAT NEEDLE OF CUTTER PROBE WAS FOUND BROKEN DURING CALIBRATION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24033536 ↗
• MalfunctionJan 9, 2026Suction Problem

  A PHYSICIAN REPORTED THAT A CUTTER COULD NOT ASPIRATE DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ACTUATION AND CUTTING OF THE CUTTER 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 24020303 ↗