International Medical Devices Database

Manufacturer Address
Optovue Inc., 45531 Northport Loop W, Fremont CA 94538-6417
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA
2 Events
- Recall of Device Recall Optovue iVue
- Recall of Device Recall Cornea Power Kit (software)

2 devices in the database

Device Recall Optovue iVue

Model / Serial
Serial numbers: 20305, 20307, 20340, 20335, 20306, 20313, 20339, 20337, 20338, 20341, 20311, 20271, 20343, 20312, 20309, 20310, 20308, 20336, 20344, 20349, 20346, 20347
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA || Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).

Device Recall Cornea Power Kit (software)

Model / Serial
Serial numbers: 12797, 12749, 12788, 12790, 12745, 12614, 12771, 11901R1.
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- CA and WA only
Product Description
RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

2 manufacturers with a similar name

Learn more about the data here

Optovue Inc.

Manufacturer Address
Optovue Inc., 45331 Northport Loop W, Fremont CA 94538-6417
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA

Optovue Inc.

Manufacturer Address
Optovue Inc., 2800 Bayview Dr, Fremont CA 94538-6518
Manufacturer Parent Company (2017)
Optovue Inc.
Source
USFDA

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Disclaimer

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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