Class 2 Device Recall TECNIS

• Date Initiated by Firm: August 26, 2016
• Date Posted: September 21, 2016
• Recall Status: Terminated on December 23, 2016
• Recall Number: Z-2856-2016
• Recall Event ID: 75051
• PMA Number: P980040
• Product Classification: intraocular lens - Product Code HQL
• Product: TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; ; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
• Code Information: ZKB00 Serial No. 8667461602 8667751602 8667471602 8667761602 8667481602 8667771602 8667491602 8667781602 8667501602 8667801602 8667511602 8667811602 8667521602 8667821602 8667531602 8667831602 8667541602 8667841602 8667551602 8667851602 8667561602 8667861602 8667571602 8667871602 8667581602 8667881602 8667591602 8667891602 8667601602 8667901602 8667611602 8667911602 8667621602 8667921602 8667631602 8667931602 8667641602 8667961602 8667661602 8667971602 8667671602 8667981602 8667681602 8667991602 8667691602 8668001602 8667701602 8668011602 ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506
• Recalling Firm/ Manufacturer: Abbott Medical Optics Inc. (AMO); 1700 E Saint Andrew Pl; Santa Ana CA 92705-4933
• For Additional Information Contact: 714-247-8200
• Manufacturer Reason for Recall: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
• FDA Determined Cause: Process control
• Action: Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.
• Quantity in Commerce: 77 units
• Distribution: Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
• 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 = Johnson & Johnson Surgical Vision, Inc.