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Bio-Eye®

INTEGRATED ORBITAL IMPLANTS INC · Model I00018S · UDI-DI 00854066006014

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

Description

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.

Recalls

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

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

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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.