Synergetics 12.03.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841305102306), received between Oct 11, 2024 and Oct 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THE OR STAFF HAD PLACED THE 12.03.25 ON A SLIP TIP SYRINGE. THE FIRST TIME THE DOCTOR USED THE ITEM IN THE CASE THE ITEM SEEMED TO WORK FINE. THE ITEM WAS USED A SECOND TIME, WHILE THE ITEM WAS THRU THE CANNULA AND INTO THE GLOBE, THE ENTIRE ITEM DETACHED FROM THE END OF THE SYRINGE CAUSING INJURY. THE ITEM DID NOT COME APART ITSELF. THE ITEM WAS SET UP CORRECTLY BY THE STAFF, BUT FOR THE SECOND USE, IT FELT DIFFERENT. THE DOCTOR REPAIRED THE INJURY, USED OIL IN THE EYE AND THE PATIENT WILL NEED TO COME BACK FOR AN ADDITIONAL SURGERY. RISK MANAGEMENT REPORTED THERE WAS POSSIBLY TWO TEARS IN THE RETINA. THE PATIENT WILL HAVE TO RETURN TO REMOVE THE OIL AND POSSIBLY REPAIR THE RETINA. THE RISK MANAGER HAD NOT SPOKEN TO THE DOCTOR YET TO CONFIRM AND PROVIDE MORE DETAILS.

  Patient problems: Retinal Tear

  MAUDE report 20427641 ↗