Recall Z-0071-2018 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
Aaren Scientific Inc.
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.
| Date | Sep 1, 2017 |
| Status | Terminated |
| Reason | The recommended storage temperature on the label is incorrect. |
| 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 Z28recall.med.us@ZEISS.com within |
| Quantity | 786 boxes |
| Distribution | Nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM Aaren Scientific, Inc., Apr 15, 2013 |