Class 2 Device Recall AERO IOL Injection System, Z28 Cartridges

• Date Initiated by Firm: September 01, 2017
• Create Date: November 08, 2017
• Recall Status: Terminated on May 01, 2018
• Recall Number: Z-0071-2018
• Recall Event ID: 78037
• 510(K)Number: K123888
• Product Classification: Folders and injectors, intraocular lens (iol) - Product Code MSS
• 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.
• 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.
• Recalling Firm/ Manufacturer: Aaren Scientific Inc.; 1040 S Vintage Ave Ste A; Ontario CA 91761-3631
• For Additional Information Contact: Owen J. Bry; 909-906-5119
• Manufacturer Reason for Recall: The recommended storage temperature on the label is incorrect.
• FDA Determined Cause: Error in labeling
• Action: Aaren Scientific sent an Urgent Medical Device Recall letter dated August 31, 2017. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1.Compare your inventory against the above list. 2. STOP using and REMOVE from your inventory all affected Z28 listed above. 3. Complete and return the attached Customer Reply Form EVEN IF YOU HAVE NO INVENTORY affected by this recall, to Aaren Scientific, Inc. Quality Management at (909) 937-1033 or email to Z28recall.med.us@ZEISS.com within 3 business days of receipt of this letter. Upon notification, Aaren Scientific, Inc. will supply you with a Return Good Authorization Number to replace all remaining customer inventory of the affected product immediately. Aaren Scientific, Inc. requires this information for reconciliation purposes with regulatory agencies. No other Aaren Scientific, Inc. Z28 Cartridges are affected by this action. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have inventory of any of the Z28 Cartridges with the batch numbers listed, please contact Customer Support at (909) 937-1033 to arrange pick up of lenses to be returned. Page 2 of 4 If you have product complaints or adverse events to report regarding the use of the Z28 cartridge, please inform Aaren Scientific, Inc. by calling. When reporting a complaint, please provide the Z28 cartridge batch number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. For questions regarding this recall call 909-906-5119.
• Quantity in Commerce: 786 boxes
• Distribution: Nationwide distribution including Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MSS and Original Applicant = AAREN SCIENTIFIC, INC