FDA-Device2017-11-15Class II
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.
Aaren Scientific Inc.
Hazard
The recommended storage temperature on the label is incorrect.
Sold states
Nationwide distribution including Puerto Rico.
Affected count
786 boxes
Manufactured in
1040 S Vintage Ave Ste A, N/A, Ontario, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2018Don't want to check this manually?
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