CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065830077Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 00380658300777), received between Mar 24, 2021 and Sep 30, 2026 — classified as 9 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (87 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-2647-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut; Ambient Noise Problem

  A non-healthcare professional reported that the vitrectomy probes were making weird noises and not cutting at an unknown timing. The surgery type, procedure completion details were unknown. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50943105 ↗
• MalfunctionSep 30, 2026Use of Device Problem

  A healthcare professional reported via health authority that the cutter failed to operate during vitrectomy surgery. The procedure was completed on same day by replacing it with a new unit of the same type. There was no information reported about patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942544 ↗
• MalfunctionSep 28, 2026Failure to Cut

  A non-health care professional reported that probe would stop cutting after a couple minutes into surgery. The surgery details and patient impact were unknown.

  Patient problems: Insufficient Information

  MAUDE report 50915642 ↗
• MalfunctionSep 25, 2026Failure to Cut

  A nurse reported that the cutter was operating but was unable to cut during surgery. The procedure type was unknown. The surgery was completed on same day, after replacing the product with new one. There was no impact on the patient. This report pertains to the second of the two probes involved in this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895810 ↗
• MalfunctionSep 25, 2026Failure to Cut

  A nurse reported that the cutter was operating but was unable to cut during surgery. The procedure type was unknown. The surgery was completed on same day, after replacing the product with new one. There was no impact on the patient. This report pertains to the first of the two probes involved in this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895809 ↗
• MalfunctionAug 14, 2026Suction Problem; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249319 ↗
• MalfunctionAug 12, 2026Suction Problem; Failure to Cut

  A health care professional reported the cutter (vitrectomy probe) was defective, and suction and cutting were not possible before vitrectomy surgery. 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 50221311 ↗
• MalfunctionAug 11, 2026Use of Device Problem; Suction Problem

  A health care professional reported that the cutter malfunctioned due to poor suction, and the cutter handle was sticky during the vitrectomy surgery. The surgery was completed on the same day, but the procedure completion details were unknown. There was no impact on patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206488 ↗
• MalfunctionApr 29, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT SUCTION AND CUTTING WAS NOT POSSIBLE BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027293 ↗
• MalfunctionFeb 25, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT PROBE CLOGGED AND STOPPED EXTRACTING FLUID DURING VITRECTOMY SURGERY. 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 24442693 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT PROBE STOPPED CUTTING DURING VITRECTOMY SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE SURGERY WAS COMPLETED BY OPENING NEW PROBE.

  Patient problems: Insufficient Information

  MAUDE report 24386477 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUT OF THE VITRECTOMY DID NOT WORK AT AN UNKNOWN TIMING. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY COMPLETION DETAILS WERE UNKNOWN BUT PRODUCT REPLACED WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24362418 ↗
• MalfunctionFeb 11, 2026Suction Problem; Failure to Cut

  A NURSE REPORTED THAT THE VITRECTOMY PROBE STOPPED CUTTING AND ASPIRATION DURING PARS PLANA VITRECTOMY SURGERY FOR THE RIGHT EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319685 ↗
• MalfunctionFeb 10, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PRODUCT COULD NOT HOLD THE VACUUM BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED REPLACING THE PACK WITH NEW ONE. THERE WAS NO PATIENT CONTACT AND IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301943 ↗
• MalfunctionFeb 5, 2026Suction Problem; Obstruction of Flow

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT AFTER CONNECTING THE VIT PROBE TO DEVICE FOR TESTING, IT WAS FOUND THAT THE HEAD OF THE PNEUMATIC TUBING WAS NOT UNOBSTRUCTED (OCCLUDED) AND COULD NOT BE USED. A NEW ONE WAS IMMEDIATELY REPLACED FOR THE PATIENT, DELAYING THE PATIENT'S SURGERY WITHOUT CAUSING ANY OTHER IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265807 ↗
• MalfunctionJan 23, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTING WAS SLOW DURING ROSO (REMOVAL OF SILICONE OIL) RETINECTOMY PVR (PROLIFERATIVE VITREORETINOPATHY PEEL) OIL SURGERY FOR THE RIGHT EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159119 ↗
• MalfunctionJan 20, 2026Fitting Problem; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOMY CUTTER HAD A NOTCH (DEFORMED) AND DID NOT FIT TIP DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE CUSTOM PAK. THE PRODUCT WAS CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113705 ↗
• MalfunctionJan 12, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTING FAILURE OF CUTTER 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 WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032734 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATOR WAS NOT CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23922625 ↗
• MalfunctionDec 25, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT AND THERE WAS AN ABNORMAL SOUND OCCURRED 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 23891775 ↗
• MalfunctionDec 23, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT NO ASPIRATION WAS OBSERVED DURING RETINAL COMPLETE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT AND IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878401 ↗
• MalfunctionDec 23, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE KIT PRESENTED PROBLEMS WITH THE VITRECTOMY CUTS, AS IT JAMMED AND PREVENTED THE SURGERY FROM CONTINUING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING WITH A NEW VITRECTOR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877980 ↗
• MalfunctionDec 16, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VITRECTOMY PROBE WOULD SHAVE/CUT BUT NOT VACUUM AT UNKNOWN TIMING. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814329 ↗
• MalfunctionDec 11, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE STOPPED CUTTING AT AN UNKNOWN TIMING OF THE SURGERY. THE PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION REPORTED ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23776160 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT PROBE STOPPED CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY BY REPLACING ANOTHER PRODUCT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755507 ↗