Stellaris BL11110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00757770480678), received between Apr 26, 2022 and Feb 5, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Infusion or Flow Problem

  THE USER FACILITY IN FRANCE REPORTED THAT DURING A VITRECTOMY, THE IRRIGATION WAS TOO LOW TO CONTINUE. IT WAS VERY LOW EVEN WHEN THEY SET THE IV POLE HIGHER. THE SURGEON FELT UNCOMFORTABLE AND DID NOT PROPERLY END THE VITRECTOMY SURGERY. THE PROCEDURE WAS ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 24270146 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN JAPAN REPORTED THAT DURING CATARACT SURGERY THE IRRIGATION PRESSURE WAS TOO HIGH AND AFTER INSERTING THE HANDPIECE THE CAPSULE RUPTURED. THE SYSTEM WAS SWITCHED OUT TO A DIFFERENT MANUFACTURER AND A VITRECTOMY WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23881352 ↗
• MalfunctionNov 6, 2025Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN UNITED KINGDOM REPORTED THE SYSTEM SHUT DOWN DURING A PROCEDURE. THE SYSTEM WAS REBOOTED AND THE PROCEDURE RESUMED WITH NO FURTHER ISSUES. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487118 ↗
• InjuryMay 6, 2025Unintended Ejection; Unintended Ejection

  A USER FACILITY IN JAPAN REPORTED THAT DURING A PROCEDURE, WHEN STARTING ASPIRATION, THE CASSETTE WAS EJECTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2025 FROM AFFILIATE STATES THAT DURING THE SURGERY, DESPITE REPLACING THE UNIT WITH A NEW PACK, THE ISSUE WAS NOT RESOLVED. THE SURGERY WAS SUSPENDED ABOUT 2 HOURS AND 30 MINUTES. FOLLOWING AN ON-SITE INSPECTION BY THE TECHNICIAN, THE PROCEDURE WAS RESUMED AND COMPLETED WITHOUT FURTHER COMPLICATIONS. (DETAILS REGARDING THE USE OF ADDITIONAL ANESTHESIA REMAIN UNKNOWN.) WHILE A MALFUNCTION WAS INITIALLY SUSPECTED, A SUBSEQUENT INSPECTION CONDUCTED ON THE FOLLOWING MORNING DID NOT REVEAL ANY ABNORMALITIES WITH THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970096 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN AUSTRALIA REPORTED 2 CASES WHERE THE ANTERIOR CHAMBER COMPLETELY COLLAPSED DURING SEGMENT STAGE WITH THE PHACO TIP COMPLETELY IN THE EYE. BOTH TIMES THE CAPSULAR BAG WAS TORN AND RESULTED IN VITRECTOMIES. THE CASES ENDED UP HAVING TO BE ABANDONED AND WILL NEED A VR SURGEON TO REVISIT FOR A POSTERIOR VITRECTOMY AND SULCUS LENS. THIS REPORT IS FOR THE 1ST PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21636175 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN AUSTRALIA REPORTED 2 CASES WHERE THE ANTERIOR CHAMBER COMPLETELY COLLAPSED DURING SEGMENT STAGE WITH THE PHACO TIP COMPLETELY IN THE EYE. BOTH TIMES THE CAPSULAR BAG WAS TORN AND RESULTED IN VITRECTOMIES. THE CASES ENDED UP HAVING TO BE ABANDONED AND WILL NEED A VR SURGEON TO REVISIT FOR A POSTERIOR VITRECTOMY AND SULCUS LENS. THIS REPORT IS FOR THE 2ND PATIENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 21636062 ↗
• MalfunctionJun 29, 2023Unexpected Shutdown; Unexpected Shutdown

  THE USER FACILITY IN GERMANY REPORTED THAT THE THE INITIAL SCREEN FLICKERED FOLLOWED BY A SYSTEM SHUT DOWN. THERE WERE NO ERROR MESSAGES. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 3 MINUTES AND WAS COMPLETED BY USING A BACK-UP SYSTEM. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17228178 ↗
• InjuryApr 26, 2022Circuit Failure; Circuit Failure

  THE USER FACILITY IN THE (B)(6) REPORTED AN ERROR MESSAGE APPEARING ON THE STELLARIS UNIT DURING SURGERY. USM01 ERROR, THE ULTRASOUND MODULE WAS NOT DETECTED IN THE SYSTEM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR THE SURGERY TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207501 ↗