Devices

Device Recall Custom Pak (Custom Pak in which Alcon 25 TOTALPLUS Vitrectomy Pak is a component.)

Model / Serial
Lot 507492, 507664, 507539
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
Product Description
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) || Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Manufacturer
Alcon Research, LTD.
1 Event
- Recall of Device Recall Custom Pak (Custom Pak in which Alcon 25 TOTALPLUS Vitrectomy Pak is a component.)

Manufacturer

Alcon Research, LTD.

Manufacturer Address
Alcon Research, LTD., 9965 Buffalo Speedway, Houston TX 77054-1309
Manufacturer Parent Company (2017)
Novartis Ag
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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