Synergetics BL7600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841305111896), received between Jan 4, 2023 and Jul 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Connection 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY IN FRANCE REPORTED THAT DURING THE INJECTION OF SILICONE OIL INTO THE PATIENT'S EYE, A POPPING NOISE WAS HEARD WHICH INTERRUPTED THE SURGERY. UPON THE SURGICAL TEAM'S INSPECTION, IT WAS NOTICED THAT THE FILTER OF THE SILICONE INJECTION LINE WAS HALF MISMATCHED. THE SURGEON SUBSEQUENTLY OBSERVED A CHOROIDAL HEMATOMA EXTENDING TO 1/3 OF THE TEMPORAL SURFACE DURING THE FUNDUS EXAMINATION. A DISCHARGE SCLEROTOMY WAS PERFORMED TO ATTEMPT TO EVACUATE THE HEMATOMA, HOWEVER IT WAS WITHOUT SUCCESS. THERE WERE ALSO POTENTIALLY SIGNIFICANT CLINICAL CONSEQUENCES WITH AN ANATOMICAL AND FUNCTIONAL PROGNOSIS RESERVED. THERE WAS NO ADDITIONAL ANESTHESIA REQUIRED FOLLOWING THE ISSUE. NO ADDITIONAL MEDICAL INTERVENTION IS PLANNED TO TREAT CHOROIDAL HEMATOMA. REASSESSMENT OF THE PATIENT'S VISION CONCLUDED THAT IT HAS NOT IMPROVED COMPARED WITH VISION BEFORE THE SURGERY.

  Patient problems: Hematoma

  MAUDE report 17367004 ↗
• InjuryJan 4, 2023Connection Problem; Connection Problem

  THE USER FACILITY IN SWITZERLAND REPORTED THAT THE CONNECTION TUBE CAME LOOSE SEVERAL TIMES AT THE LUER LOCK CONNECTION WITH THE OXANE SYRINGE. THE SILICONE OIL WAS INJECTED INTO THE EYE WITH MANUAL SUPPORT. THE EYE COLLAPSED AND ADDITIONAL ANESTHESIA WAS REQUIRED AS THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 10 MINUTES. THE INCIDENT DID NOT PUT THE PATIENT¿S EYE INTO PERMANENT OR TEMPORARY SERIOUS DETERIORATION OF PATIENT¿S STATE OF HEALTH AS THE SURGEON STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER REPORT OF ANY RE-OPERATION OF THE EYE, EYESIGHT DETERIORATION, BLEEDING, OR RETINAL DAMAGE DESPITE THERE WAS AN EYE COLLAPSE. THE POSSIBILITY OF RETINAL AND VITREOUS HEMORRHAGE, CHOROIDAL DETACHMENT DUE TO ACUTE HYPOTONY CANNOT BE RULED OUT DUE TO HYPOTONY CAUSED BY THE LOOSE CONNECTION (ALTHOUGH NO ADVERSE EVENTS OCCURRED).

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 16095754 ↗