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U.S. Department of Health and Human Services

Class 3 Device Recall EC3 Intraocular Lens

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 Class 3 Recall
EC3 Intraocular Lens
see related information
Date Posted February 22, 2012
Recall Status1 Terminated on August 10, 2012
Recall Number Z-1076-2012
Recall Event ID 60962
Premarket Approval
PMA Number
P100016
Product Classification Intraocular Lens - Product Code HQL
Product Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 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.
Code Information Lot Number: 110617
Recalling Firm/
Manufacturer
Aaren Scientific, Incorporated
4290 E Brickell St Ste A
Ontario, California 91761-1569
Manufacturer Reason
for Recall
The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
FDA Determined
Cause 2
EXPIRATION DATING: Incorrect or No Expiration Date
Action Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.
Quantity in Commerce 3 units
Distribution Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = HQL and Applicant = AAREN SCIENTIFIC INC
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