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U.S. Department of Health and Human Services

Class 2 Device Recall Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL

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  Class 2 Device Recall Aaren Scientific Intraocular Lens (IOL), Part No. EC3 PAL see related information
Date Initiated by Firm February 13, 2015
Date Posted March 20, 2015
Recall Status1 Terminated 3 on June 29, 2015
Recall Number Z-1309-2015
Recall Event ID 70557
PMA Number P100016 
Product Classification intraocular lens - Product Code HQL
Product Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0.

The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
Code Information Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.
Recalling Firm/
Manufacturer		 Aaren Scientific, Incorporated
4290 E Brickell St Ste A
Ontario CA 91761-1569
For Additional Information Contact
909-937-1033 Ext. 108
Manufacturer Reason
for Recall		 Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
FDA Determined
Cause 2		 Labeling design
Action A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at mark.scheib@zeiss.com with any questions or comments.
Quantity in Commerce 28 units
Distribution Distributed in the states of OK, KS, FL, and AL.
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.
PMA Database PMAs with Product Code = HQL and Original Applicant = Carl Zeiss Meditec Production LLC
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