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Devices
Device Recall BioEye
Model / Serial
Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
Internationally to Finland & France
Product Description
Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Manufacturer
Integrated Orbital Implants Inc
1 Event
Recall of Device Recall BioEye
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Manufacturer
Integrated Orbital Implants Inc
Manufacturer Address
Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
Source
USFDA
Language
English
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