Synergetics BL7620Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841305111162), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DOCTOR WAS CONCERNED WITH THE LENGTH OF THE CANNULA. IN A RECENT CASE WHILE INJECTING 5000 CS SILICONE OIL, THE PATIENT DEVELOPED MULTIPLE CHOROIDALS DUE TO THE CANNULA NOT CLEARING THE CHOROIDAL SPACE. ADDITIONAL SURGERY TIME WAS REQUIRED TO RECTIFY THE ISSUE. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED. ADDITIONAL INFORMATION FROM THE DOCTOR: THE COMPLICATION WAS SILICONE OIL PARTIALLY INJECTED INTO THE SUPRACHOROIDAL SPACE DUE TO NONPENETRATING (OR PARTIALLY PENETRATING) SHORT TIP OF THE CANNULA THROUGH THE SCLEROTOMY. IT IS ESTIMATED A LARGE VOLUME POSSIBLY 2-3 CC ENDED UP IN THE SUPRACHOROIDAL SPACE AND WHEN REALIZED, SCLEROTOMIES WERE ENLARGED IN 4 QUADRANTS IN THE EQUATOR TO DRAIN AS MUCH OF IT AS POSSIBLE, EXTENDING THE SURGERY TIME ABOUT ONE HOUR. EXAMINATION AT ONE DAY AND ONE WEEK AFTER THE SURGERY SHOWED NO SILICONE OIL IN THE SUPRACHOROIDAL SPACE IN THE MACULAR AREA, BUT THERE WAS STILL SIGNIFICANT AMOUNT (ESTIMATED 1-2 CC) STILL IN THE SUPRACHOROIDAL SPACE IN THE PERIPHERY. THERE APPEARED TO BE NO CLINICAL CONSEQUENCE AT THE END OF 1 WEEK POST OP TIME, BUT LONG TERM ADVERSE EFFECT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286816 ↗