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Scleral buckling device, non-bioabsorbable

FCI S A S FCI 20 22 · Model GROOVED SPONGE 7.5 x 3.5 TYPE 509 G · UDI-DI 03760087122008

HQX Prescription
10
510(k) clearances
26
Adverse events
13
Recalls
13
Facilities

Description

A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

Recalls

DateFirmReason
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.