Constellation 8065750957Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 00380657509577), received between May 7, 2021 and Sep 24, 2026 — classified as 4 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Defective Device” (55 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. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0305-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Use of Device Problem

  A physician reported that negative pressure could not be generated during vitrectomy surgery. The surgery was completed on same day by replacing it with new product. There was no information reported about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50883323 ↗
• MalfunctionSep 13, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747684 ↗
• MalfunctionSep 11, 2026Use of Device Problem

  A Nurse reported that plunger of the viscoelastic control set failed at a vacuum setting 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 50731936 ↗
• MalfunctionSep 9, 2026Use of Device Problem

  A nurse reported that under a vacuum pressure of 650 millimeters of mercury, plunger failed to retract properly, preventing normal silicone oil removal during surgery. The procedure type was unknown. The surgery was successfully completed on same day by replacing it with new viscoelastic control tubing. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693362 ↗
• MalfunctionSep 9, 2026Defective Alarm

  A physician reported that the unable to create vacuum during vitrectomy surgery. The surgery was completed on the same day after replacing the new tube. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50686483 ↗
• MalfunctionSep 8, 2026Use of Device Problem

  A nurse reported that the surgeon performed a left eye silicone oil removal surgery. After completing the patient's preliminary surgical preparations, the surgeon prepared to remove the silicone oil. The viscoelastic control tubing was opened, and the plunger within the tubing was fully advanced into the syringe before being connected to the machine for silicone oil removal. During the procedure, it was observed that under a vacuum setting of 650 millimeters of mercury (mmHg), the plunger failed to retract normally, preventing the silicone oil removal procedure from being carried out as intended. The surgery was completed on same day after replacing the product with another one, and there were no other abnormalities. The patient returned smoothly to the ward after completing the surgery. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672150 ↗
• MalfunctionSep 8, 2026Use of Device Problem

  A nurse reported that the surgeon performed a right eye silicone oil removal procedure. After completion of the initial surgical steps, preparation was made for silicone oil extraction. The viscoelastic control tubing was opened, and the plunger within the tubing was inserted into the syringe and connected to the machine. During silicone oil removal, it was observed that the plunger could not retract under a vacuum setting of 650 millimeters of mercury (mmHg), preventing normal silicone oil extraction. A new viscoelastic control tubing set was replaced, and the procedure continued without further abnormalities. The patient completed the surgery and returned to the ward in stable condition. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671490 ↗
• MalfunctionSep 8, 2026Use of Device Problem

  A non-healthcare professional reported that when surgeon about to inject silicone oil in eye, the injection cannula could not put in the trocar during vitrectomy surgery. After inspecting it was found the bending of cannula. The surgery was completed on the same day after replacing the cannula with new one. There was no patient contact with the suspect product.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670838 ↗
• MalfunctionSep 8, 2026Leak/Splash

  A physician reported that air had leaked at the interface of the tubing during 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 50663053 ↗
• MalfunctionSep 8, 2026Use of Device Problem

  A nurse reported that under a vacuum pressure of six hundred fifty millimeters of mercury, the plunger could not retract properly, preventing normal silicone oil removal during right eye silicone oil removal procedure. The surgery was completed on the same day after replacing the product with a new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50661788 ↗
• MalfunctionAug 31, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50523298 ↗
• MalfunctionAug 27, 2026Use of Device Problem

  A customer reported via health authority that the surgeon used a silicone oil injection/aspiration to inject silicone oil into the vitreous cavity however, the blue connector of the injector could not be securely tightened and repeatedly popped open under injection pressure, preventing the establishment of a sealed pathway for silicone oil infusion during vitrectomy surgery. The surgeon immediately discontinued use of the affected injector and opened a new one. After confirming a secure connection, the procedure was completed successfully. There was no information about patient impact at the time of reporting.

  Patient problems: Insufficient Information

  MAUDE report 50469472 ↗
• MalfunctionAug 12, 2026Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219102 ↗
• MalfunctionJul 28, 2026Defective Device

  A physician reported that tubing was blocked preventing silicon oil injection during vitrectomy surgery. The surgery was successfully completed on same day by replacing it with new product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050625 ↗
• MalfunctionJul 27, 2026Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016600 ↗
• MalfunctionJun 30, 2026Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT. A PHYSICIAN REPORTED THAT THE VISCOUS FLUID CONTROL (VFC) WAS UNABLE TO INJECT AND EXTRACT OIL DURING VITRECTOMY SURGERY IN AN ADULT MALE PATIENT. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE SAME PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663192 ↗
• MalfunctionJun 29, 2026Defective Device

  A NURSE REPORTED THAT THE NEEDLE WITHIN THE VISCOELASTIC DELIVERY TUBING WAS OBSTRUCTED RESULTNG IN FAILURE TO ASPIRATE AS INTENDED 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 25652014 ↗
• MalfunctionJun 18, 2026Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE VISCOUS FLUID CONTROL SYRINGE BENT NEEDLE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544234 ↗
• MalfunctionJun 15, 2026Defective Device

  A NURSE REPORTED THAT AIR LEAKAGE IN THE VISCOELASTIC CONTROL TUBING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513787 ↗
• MalfunctionJun 12, 2026Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY THAT THE VISCOELASTIC CONTROL LINE WAS USED TO INJECT SILICONE OIL TUBING COULD NOT BE CONNECTED TO THE VITRECTOMY MACHINE INTERFACE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH THE SAME MODEL TUBING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481366 ↗
• MalfunctionMar 6, 2026Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE INJECTION CANNULA WAS NOT CLAMPED CAUSING SILICONE LOSS DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO INFORMATION ABOUT ANY IMPACT ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24531676 ↗
• MalfunctionMar 5, 2026Defective Component; Obstruction of Flow

  A CUSTOMER REPORTED THAT THE INFUSION CANNULA WAS DAMAGED AT THE TIP AND OBSTRUCTED AT AN UNKNOWN TIMING. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 24516258 ↗
• MalfunctionFeb 19, 2026Defective Device

  A NURSE REPORTED THAT VISCUS FLUID CONTROL DID NOT TO BE INJECTING PROPERLY AND EXTRACTION WAS NOT WORKING NORMALLY ON THE CONSOLE DURING SURGERY. THE PROCEDURE TYPE AND SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24386548 ↗
• MalfunctionFeb 5, 2026Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN ISSUE OCCURRED AT THE END OF THE SILICONE OIL TUBING, COULD NOT INJECT SILICONE OIL PROPERLY 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 24269099 ↗
• MalfunctionJan 21, 2026Defective Device

  A NURSE REPORTED THAT THE TUBING LEAKED 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 24141768 ↗