Stellaris BL1433Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00757770497836), received between Jul 19, 2021 and Apr 14, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Power Problem

  THE USER FACILITY IN RUSSIA REPORTS EXPERIENCING AN UNEXPECTED POWER INTERRUPTION TWO TO FOUR TIMES A DAY. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION/TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873465 ↗
• MalfunctionNov 11, 2024Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY IN THE CANARY ISLANDS REPORTED THAT THE SYSTEM SHUTDOWN BY ITSELF DURING SURGERY. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657036 ↗
• InjuryDec 20, 2023Decrease in Suction; Decrease in Suction

  THE USER FACILITY IN FRANCE REPORTED THAT ASPIRATION WAS LOST DURING THE PROCEDURE. THE PATIENT WAS MOVED TO A DIFFERENT OPERATION ROOM WHERE ANOTHER SYSTEM WAS USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS EXTENDED BY 55 MINUTES. CURRENTLY, THERE IS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364991 ↗
• InjurySep 28, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT DURING THE CASE THE EYE BECAME HARD DUE TO HIGH PRESSURE CAUSING THE IRIS TO PROLAPSE. WHEN CHECKED THE INFUSION PRESSURE WAS SET TO 35MMHG. THE IRIS WAS REDEPOSITED SUCCESSFULLY AND THE ANTERIOR CHAMBER REFORMED. SURGERY WAS COMPLETED SAFELY, BUT THE IOP FLUCTUATIONS DID COMPROMISE THE CORNEAL VIEW TO SOME EXTENT MAKING THE LATER STAGES OF THE MEMBRANE PEEL MORE CHALLENGING. I WASN¿T TIMING THE SURGERY, BUT THE VITRECTOMY CUTTER IS INEFFICIENT AND THE GEL TRIMMING TOOK LONGER THAN IT SHOULD HAVE. A SMALL VOLUME OF ANESTHESIA TOP-UP WAS NEEDED. APART FROM A SLIGHTLY DILATED PUPIL, EVEN FOLLOWING MIOCHOL-E, THE EYE IS QUIET WITH A NORMAL IOP.

  Patient problems: Eye Injury; Intraocular Pressure Increased; Prolapse

  MAUDE report 17839341 ↗
• InjuryMay 9, 2023Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THEY TRIED TO USE THE FOOT PEDAL AND HAD NO RESPONSE FROM IT DURING SEGMENT REMOVAL. THE OPERATION WAS STOPPED AND THE PATIENT WAS SENT BACK TO WARD FROM THEATRE WITH ONLY THE CAPSULOROHEXIS HAVING BEEN DONE AND PHACO NOT STARTED. THIS CAUSED SOME CORNEAL INFLAMMATION. THE PATIENT WAS NOT LEFT APHAKIC. AFTER A 90 MINUTE DELAY, WHEN THE SYSTEM WAS WORKING AGAIN THE OPERATION WAS COMPLETED THE SAME AFTERNOON. AN ADDITIONAL TOP UP OF TOPICAL ANESTHESIA WAS GIVEN. A FOLLOW UP WITH THE PATIENT SHOWS THEY ARE DOING WELL WITH NO CONCERNS REGARDING VISUAL OUTCOME.

  Patient problems: Inflammation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899284 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN (B)(6) REPORTED THAT DURING SURGERY THE ASPIRATION DID NOT WORK WITH THE ANTERIOR VITRECTOMY. A NEW VITRECTOMY WAS TRIED AND THE ASPIRATION STILL DID NOT WORK. THE PROCEDURE WAS PROLONGED BY TWO (2) HOURS AND ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE SURGERY. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Insufficient Information

  MAUDE report 12191820 ↗