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Devices
AERO IOL Injection System, Z28 Cartridges
Model / Serial
Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.
Product Classification
Ophthalmic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution including Puerto Rico.
Product Description
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. || Used to fold and insert the firm's IOL's.
Manufacturer
Aaren Scientific Inc.
1 Event
Recall of AERO IOL Injection System, Z28 Cartridges
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Manufacturer
Aaren Scientific Inc.
Manufacturer Address
Aaren Scientific Inc., 1040 S Vintage Ave Ste A, Ontario CA 91761-3631
Manufacturer Parent Company (2017)
Carl-Zeiss-Stiftung
Source
USFDA
Language
English
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