Orbit Subretinal Delivery System PN1007128-002CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860000540513), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective 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 18, 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.

• MalfunctionJul 15, 2020Defective Component; Dull, Blunt; Defective Component; Dull, Blunt

  THE ORBIT SUBRETINAL DELIVERY SYSTEM (SDS) WITH THE CURVED NEEDLE CONFIGURATION WAS USED ON (B)(6) 2020 FOR DELIVERY OF AN INVESTIGATIONAL CELL THERAPY UNDER AN APPROVED IND STUDY. DURING THE PROCEDURE THE SDS WAS UNABLE TO PASS THROUGH THE CHOROID TO ACCESS THE SUBRETINAL SPACE. AFTER 30 MINUTES OF ATTEMPTING TO ACCESS THE SUBRETINAL SPACE TO CREATE THE ENTRY BLEB, THE CELL VIABILITY WINDOW HAD EXPIRED; THEREFORE, THE NEEDLE OF THE INJECTION CANNULA WAS RETRACTED AND THE DEVICE WAS REMOVED FROM THE PATIENT. UPON EXAMINATION, THE RETINA SPECIALIST REPORTED OBSERVING A DEFECT AT THE DISTAL TIP OF THE NEEDLE WHICH HE DESCRIBED AS A BURR; POST-SURGERY IMAGES CONFIRMED PRESENCE OF A BEND AT THE DISTAL NEEDLE TIP. A SECOND ORBIT SDS DEVICE WAS USED TO SUCCESSFULLY CREATE THE ENTRY BLEB AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE EVENT DID NOT RESULT IN ANY ADVERSE IMPACT TO THE PATIENT, WHO WAS REPORTED TO BE HEALING NICELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10279867 ↗