Stellaris BL11114Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00757770520190), received between Dec 9, 2024 and Nov 18, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE VETERINARY SYSTEM STOPPED SUCTIONING DURING THE CASE AND WOULD NOT ASPIRATE ANY LONGER. THERE WAS NO BACKUP SYSTEM ON SITE. INITIALLY, ENOUGH GENERAL ANESTHESIA WAS ADMINISTERED TO BE ABLE TO COMPLETE BOTH EYES. THE LEFT EYE WAS COMPLETED, BUT THE DOCTOR BELIEVES A RADIAL TEAR OCCURRED DUE TO THE HANDPIECE NOT ASPIRATING CORRECTLY. FOR THE RIGHT EYE, THE CANINE PATIENT HAD TO BE WOKEN, AND DUE TO THEIR DIABETES WAIT FOR ABOUT 6 HOURS TO TRANSFER TO ANOTHER FACILITY. THE PATIENT WAS PUT BACK UNDER GENERAL ANESTHESIA AT THE OTHER FACILITY AND THE RIGHT EYE WAS COMPLETED. LENSES WERE INSERTED IN BOTH EYES.

  Patient problems: Eye Injury

  MAUDE report 23584008 ↗
• InjuryJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CHINA NATIONAL DEVICE ADVERSE EVENT REPORTING SYSTEM SUBMITTED THIS REPORT WHERE THERE WAS A POSTERIOR CAPSULE RUPTURE DURING CATARACT SURGERY. THERE WAS A SUDDEN LOSS OF INFUSION DURING SURGERY (INFUSION FLUID IS PRESENT) CAUSING THE PATIENT'S ANTERIOR CHAMBER TO COLLAPSE AND THE POSTERIOR CAPSULE TO RUPTURE. THE VITREOUS WAS PARTIALLY REMOVED AND AN INTRAOCULAR LENS WAS IMPLANTED IN THE CILIARY SULCUS. THE PATIENT'S CONDITION WAS TEMPORARILY STABILIZED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22609246 ↗
• MalfunctionJun 6, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY REPORTED THE SYSTEM SHUTDOWN DURING SURGERY 2 TIMES IN LAST 2 MONTHS. THEY REBOOTED THE SYSTEM AND THEN IT WAS OK. FOOT CONTROL WAS PLUGGED IN DURING THE SHUTDOWNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157474 ↗
• MalfunctionDec 9, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT THE SYSTEM LOST POWER DURING A PROCEDURE. THEY WIGGLED THE POWER CORD, AND IT CAME BACK ON. THE SITE THEN TAPED THE CORD TO THE MACHINE AND LOST POWER AGAIN. THEY USED A BACKUP SYSTEM TO CONTINUE. NO PATIENT IMPACT OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880098 ↗