Scleral Buckling Products: Style 506, 3.0mm x 5.0mm Oval Sponge 92-50-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872014630), received between Jun 11, 2018 and Jun 11, 2018 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY HAS VERBALLY REPORTED THE FOLLOWING INCIDENT. THE PATIENT HAD A SCLERAL BUCKLE IMPLANT ON (B)(6) 2017 FOR RETINAL DETACHMENT. THE PATIENT CAME BACK (THE DATE THAT WAS REPORTED WAS UNKNOWN) AND REPORTED SPONGE IRRITATION. INFECTION WAS SUSPECTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE IMPLANT REMAINS IN PLACE AND THE EVENT HAS RESOLVED. THERE ARE NO SAMPLES.

  Patient problems: Intraocular Infection

  MAUDE report 7588948 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY HAS REPORTED SURGICAL REMOVAL OF AN EYE IMPLANT DUE TO INFECTION. THE DATE OF SURGERY FOR A RETINAL DETACHMENT OCCURRED ON (B)(6) 2017 WHEN THIS DEVICE WAS IMPLANTED. THEN ON (B)(6) 2018 THE SCLERAL BUCKLE WAS REMOVED FOR INFECTION. THE DEVICE WAS REMOVED AND SENT TO PATHOLOGY. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THAT THE PATHOLOGY REPORT INDICATED A FEW GRAM + COCCI. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE CULTURE WAS REPEATED AND RESULTS INDICATE NO GROWTH. THE INCIDENT HAS FULLY RESOLVED. THE FACILITY HAS RETURNED UNUSED SAMPLES FROM THIS LOT FOR AN EVALUATION.

  Patient problems: Foreign Body In Patient; Intraocular Infection

  MAUDE report 7588935 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY HAS REPORTED A SURGICAL REMOVAL OF AN EYE IMPLANT DUE TO INFECTION AND EXTRUSION. THE INITIAL DATE OF SURGERY FOR A RETINAL DETACHMENT OCCURRED ON (B)(6) 2017 FOR PLACEMENT OF THIS DEVICE. THEN ON (B)(6) 2018 THE SCLERAL BUCKLE WAS REMOVED FOR INFECTION AND EXTRUDING. THE DEVICE WAS REMOVED AND THEN SENT TO PATHOLOGY. IT WAS REPORTED PATHOLOGY REPORT INDICATED OCCASIONAL GRAM + COCCI. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE INCIDENT HAS FULLY RESOLVED. THE FACILITY HAS RETURNED UNUSED SAMPLES FROM THIS LOT FOR EVALUATION.

  Patient problems: Foreign Body In Patient; Intraocular Infection

  MAUDE report 7588927 ↗