Device product
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.
Z-0071-2018
Product summary
- Event
- Event 78037
- Status
- Terminated
- Classification
- Class II
- Quantity
- 786 boxes
- Official record key
device-enforcement:Z-0071-2018
Official wording
Reason: The recommended storage temperature on the label is incorrect.
Code information: 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.
Distribution pattern: Nationwide distribution including Puerto Rico.
Derived failure modes
-
Labeling or packaging
label is incorrect