Z-0071-2018Class II

AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm...

Name: Z-0071-2018 AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm...
Creator: Aaren Scientific Inc.
Published: 2017-09-01
License: https://open.fda.gov/license/

Aaren Scientific Inc. / initiated 2017-09-01 / Terminated / root cause: labeling and UDI

FDA source

Aaren Scientific Inc. began a recall of 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... on 2017-09-01. FDA classified it as Class II and gives the reason as "The recommended storage temperature on the label is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0071-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Posted: 2017-11-08
Terminated: 2018-05-01
Recalling firm: Aaren Scientific Inc.
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.
Product code: MSS Folders And Injectors, Intraocular Lens (Iol)
Reason for recall: The recommended storage temperature on the label is incorrect.
Root cause tag: labeling and UDI
FDA root 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 [email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code MSS

K123888Class IZ Cartridge IOL Delivery SystemAaren Scientific, Inc. / cleared 2013-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)