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Ophthalmic conformer
FCI S A S FCI 20 22 · Model PERFORATED CONFORMER LARGE SIZE · UDI-DI 03760087122756
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
| Date | Firm | Reason |
|---|---|---|
| 2008-03-28 | Porex Surgical, Inc. | The Ocular Conformers were distributed with an expired expiration date. |
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Get your free API keyRead the docsData 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.