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U.S. Department of Health and Human Services

Class 3 Device Recall SP65A2 UVAbsorbing Posterior Chamber Intraocular Lens

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  Class 3 Device Recall SP65A2 UVAbsorbing Posterior Chamber Intraocular Lens see related information
Date Initiated by Firm August 02, 2011
Date Posted February 22, 2012
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-1079-2012
Recall Event ID 60962
PMA Number P970034 
Product Classification Intraocular lens - Product Code HQL
Product UV-Absorbing Posterior Chamber IOL
Model: SP-65A2,
Serial Number:

1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, 1168581106, 1168591106, 1168601106, 1168611106.

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 CA 91761-1569
For Additional Information Contact
909-937-1033 Ext. 108
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		 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 15 units
Distribution Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
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 = AAREN SCIENTIFIC
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