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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 28, 2016
Date Posted September 01, 2016
Recall Status1 Terminated 3 on June 07, 2017
Recall Number Z-2708-2016
Recall Event ID 74824
PMA Number P930014S084 
Product Classification intraocular lens - Product Code HQL
Product Alcon AcrySof IQ IOL with ULTRASERT Delivery System

Product Usage:
The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
Code Information Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
800-862-5266
Manufacturer Reason
for Recall		 The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
FDA Determined
Cause 2		 Process control
Action Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon.
Quantity in Commerce 371 units
Distribution Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
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 = ALCON LABORATORIES, INC.
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