CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753106Recalls & reported problems

Summary

The FDA's MAUDE database contains 546 adverse event reports that list this exact device (DI 00380657531066), received between Jul 13, 2021 and Sep 30, 2026 — classified as 17 injuries, 529 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (365 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Jul 15, 2024Open, Classified

   Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

   Z-2680-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 546 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut

  A non-healthcare professional reported that packs (probes) were experiencing inconsistent vitrectomy cutting. The surgery details and patient impact details were unknown.

  Patient problems: Insufficient Information

  MAUDE report 50943555 ↗
• MalfunctionSep 30, 2026Suction Problem

  A non healthcare professional reported that no fluid dynamic/aspiration with cutter at unknown timing. The procedure type and completion details were unknown. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50943553 ↗
• MalfunctionSep 30, 2026Failure to Cut

  A non-healthcare professional reported that packs (probes) were experiencing inconsistent vitrectomy cutting. The surgery details and patient impact details were unknown.

  Patient problems: Insufficient Information

  MAUDE report 50943552 ↗
• MalfunctionSep 30, 2026Failure to Cut

  A physician reported that the vitrectomy probe cutting speed was reduced during vitrectomy surgery. The surgery was completed after replacement of product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943428 ↗
• MalfunctionSep 29, 2026Use of Device Problem

  A physician reported that the vitrectomy probe did not work during vitrectomy surgery. The surgery was completed on 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 50934801 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  A nurse reported that the cutter (vitrectomy probe) did not work on machine during surgery. The surgery type, procedure completion details were unknown. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50933483 ↗
• MalfunctionSep 29, 2026Suction Problem; Failure to Cut

  A physician reported that cutting of cutter was poor and aspiration of cutter was not possible 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 50928860 ↗
• MalfunctionSep 28, 2026Failure to Cut

  A healthcare professional reported that vitrectomy probe could not cut during vitrectomy surgery. The surgery was completed on the same day, after replacing the product with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50915638 ↗
• MalfunctionSep 28, 2026Failure to Cut

  A health care professional reported that probe could not cut during the vitrectomy surgery. The surgery was completed on the same day but unknown how it was completed. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50911540 ↗
• MalfunctionSep 27, 2026Suction Problem; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909581 ↗
• MalfunctionSep 22, 2026Obstruction of Flow

  A healthcare professional reported that the posterior segment infusion tip was occluded and could not be flushed open using a syringe before vitrectomy surgery. The surgery was completed on the same day. There was no information about patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856148 ↗
• MalfunctionSep 22, 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 by replacing with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856147 ↗
• MalfunctionSep 22, 2026Suction Problem

  A Physician reported that poor aspiration of probe was observed 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 50852646 ↗
• MalfunctionAug 20, 2026Suction Problem; Failure to Cut

  A non-healthcare professional reported that the cutter (vitrectomy probe) did not cut, and the maximum vacuum setting reached 450 millimeters of mercury (mmHg) 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 50339409 ↗
• MalfunctionAug 14, 2026Failure to Cut

  A physician reported that the cutter did not cut during surgery. The procedure type was unknown. The surgery 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 50249318 ↗
• MalfunctionAug 12, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218885 ↗
• MalfunctionAug 11, 2026Break

  A healthcare professional reported that cutter broke mid of the vitrectomy procedure, piece of metal came off the end of the cutter into back of the eye and surgeon was able to retrieve it and the fragment was removed during the same surgery. The surgery was completed on the same day but replacement details were unknown. There was no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206986 ↗
• MalfunctionJul 22, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE DID NOT CUT DURING CALIBRATION. THE PROCEDURE TYPE AND SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25902290 ↗
• MalfunctionJun 8, 2026

  VITRECTOMY PROBE WOULD NOT CONNECT TO THE CONSTELLATION MACHINE WHEN PLUGGED IN. THE CONNECTOR LIGHT WOULD NOT TURN GREEN ON THE CONSTELLATION MACHINE. PROBE WAS REPLACED PRIOR TO BEGINNING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428498 ↗
• MalfunctionMay 21, 2026Failure to Cut; Ambient Noise Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOR (VITRECTOMY PROBE) DID NOT REACH THE MAXIMUM VACUUM AND THE SOUND WAS UNUSUAL DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY WITH BACKUP PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238920 ↗
• MalfunctionMay 7, 2026Infusion or Flow Problem

  A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT THE INFUSION FAILED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY, BUT IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108869 ↗
• MalfunctionApr 24, 2026Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE ADVISORY CODE DISPLAYED AND INFUSION LINE OCCLUDED DURING CALIBRATION OF SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY COMPLETION AND REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980650 ↗
• MalfunctionApr 15, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT WELL 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 24881361 ↗
• MalfunctionApr 14, 2026Leak/Splash

  A PHYSICIAN REPORTED THAT CASSETTE LEAKED WATER BEFORE 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 24868577 ↗
• MalfunctionMar 7, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT UNSTABLE CUTTING OF PROBE 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 24541099 ↗