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U.S. Department of Health and Human Services

Class 1 Device Recall ReSTOR IOL

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  Class 1 Device Recall ReSTOR IOL see related information
Date Initiated by Firm April 15, 2015
Date Posted August 07, 2015
Recall Status1 Terminated 3 on June 30, 2017
Recall Number Z-2323-2015
Recall Event ID 71630
Product Classification intraocular lens - Product Code HQL
Product ReSTOR intraocular lens and ReSTOR Toric intraocular lens.
The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
Code Information Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact N/A
800-862-5266
Manufacturer Reason
for Recall		 There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
FDA Determined
Cause 2		 Process design
Action Alcon Research sent recall notification letters dated April 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product and place on hold until their sales representatives visit their site for withdrawal. Follow up communication activities included personal contact via phone and site visits. For questions regarding this recall call 817-293-0450.
Quantity in Commerce 45,391
Distribution Distribution Japan, No US distribution.
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.
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