Devices

Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer

Model / Serial
Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
Yes
Distribution
USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
Product Description
Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
Manufacturer
Integrated Orbital Implants Inc
1 Event
- Recall of Device Recall Sterile BioEye Hydroxyapatite Orbital Implant and Conformer

Manufacturer

Integrated Orbital Implants Inc

Manufacturer Address
Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 300, San Diego CA 92130-2054
Manufacturer Parent Company (2017)
Integrated Orbital Implants Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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