Stellaris BL14304Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00757770520251), received between Jan 2, 2024 and Sep 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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.

• InjurySep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED FLUID STOP FLOWING DURING VITRECTOMY. THEY CHANGED DISPOSABLE PRODUCTS AND THE HANDPIECE AND CONFIRMED IT IS NOT A HANDPIECE ISSUE. ONCE THEY SWITCHED OUT THE PRODUCTS THEY CLOSED OUT OF THE CURRENT PROCEDURE ON THE SCREEN AND START A NEW ONE. IT TOOK ABOUT 10 MINUTES OF TROUBLESHOOTING. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND DID NOT RECEIVE ADDITIONAL ANESTHESIA TIME. BY THE TIME THE INFUSION LINE WAS REESTABLISHED, THERE WAS BLEEDING AND THE PROCEDURE NEEDED TO BE STOPPED. AFTER FOLLOWING UP WITH THE SURGEON, IT DID NOT SOUND LIKE THERE WAS ADDITIONAL DAMAGE TO THE PATIENT'S EYE, JUST THAT WE WERE NOT ABLE TO COMPLETE THE SURGERY. CURRENTLY THIS PATIENT IS NOT BOOKED FOR ANOTHER CASE.

  Patient problems: Insufficient Information

  MAUDE report 23037142 ↗
• InjuryApr 2, 2025No Audible Alarm; No Audible Alarm

  THE USER FACILITY IN FRANCE REPORTED THAT DURING THE FRAGMENTATION PHASE, WITHOUT AUDIBLE ALERT, THE PHACOEMULSIFIER SWITCHED TO MAX SUCTION MODE WITH RUPTURE. THE SUCTION TRIGGERED ON ITS OWN WHEN THE SURGEON HAD OPERATED AT THE BOTTOM OF THE GROOVE, AND WITHOUT WARNING. THE PATIENT EXPERIENCED EDEMA/INFLAMMATION AND A VITRECTOMY WAS IMPOSSIBLE DUE TO LOCAL ANESTHESIA. THE PATIENT'S BEST CORRECTED VISUAL ACUITY IS 1/20.

  Patient problems: Capsular Bag Tear; Corneal Edema; Intraocular Infection

  MAUDE report 21752066 ↗
• InjuryFeb 5, 2025Failure to Deliver Energy; Failure to Deliver Energy

  SURGEON CONFIRMED THAT THE PATIENT WAS OKAY AFTER THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315112 ↗
• InjuryJan 2, 2024Intermittent Communication Failure; Intermittent Communication Failure

  A USER FACILITY IN FRANCE REPORTED THAT THEY EXPERIENCED INTERMITTENT ULTRASOUND USE AND AS A RESULT THE INCISION WAS BURNED AND SUTURES WERE REQUIRED. THE PATIENT RECOVERED WELL, WITH NO EFFECT ON VISUAL ACUITY.

  Patient problems: Eye Burn

  MAUDE report 18427821 ↗