FDA Device Intelligence
Home › FCI S A S FCI 20 22 › SILICONE CONFORMER (FLEXIBLE)

SILICONE CONFORMER (FLEXIBLE)

FCI S A S FCI 20 22 · Model S6.2001 · UDI-DI 03760087122589

HQN Prescription
7
510(k) clearances
2
Adverse events
1
Recalls
33
Facilities

Description

An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.

Recalls

DateFirmReason
2008-03-28Porex Surgical, Inc.The Ocular Conformers were distributed with an expired expiration date.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.