Class 2 Device Recall TECNIS CL

• Date Initiated by Firm: May 13, 2014
• Date Posted: August 26, 2014
• Recall Status: Terminated on May 18, 2017
• Recall Number: Z-2272-2014
• Recall Event ID: 68346
• PMA Number: P880081
• Product Classification: intraocular lens - Product Code HQL
• Product: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5; ; Product Usage:; AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
• Code Information: 1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309 1004501311 1042861309 1166871309 1004521311 1042881309 1166881309 1004561311 1042901309 1166891309 1004581311 1042941309 1166901309 1004601311 1042961309 1166911309 1004621311 1043061309 1166921309 1004631311 1043081309 1166941309 1004641311 1043121309 1166961309 1004661311 1043141309 1166971309 1004671311 1043161309 1166981309 1004681311 1166391309 1166991309 1042091309 1166431309 1167001309 1042111309 1166441309 1167021309 1042191309 1166451309 1167041309 1042271309 1166471309 1167051309 1042291309 1166481309 1167061309 1042311309 1166511309 1167081309 1042331309 1166531309 1167101309 1042351309 1166561309 1167111309 1042391309 1166581309 1167131309 1042481309 1166601309 1167141309 1042571309 1166621309 1167151309 1042581309 1166631309 1167161309 1042591309 1166641309 1167171309 1042601309 1166661309 1167181309 1042611309 1166671309 1167201309 1042621309 1166681309 1167221309 1042631309 1166691309 1167241309 1042641309 1166701309 1167251309 1042651309 1166711309 1167261309 1042671309 1166721309 1167271309 1042681309 1166731309 1167281309 1042691309 1166741309 1167291309 1042701309 1166751309 1167301309 1042711309 1166761309 1167311309 1042721309 1166771309 1167321309 1042731309 1166781309 1167331309 1042741309 1166791309 1167351309 1167371309 1167391309 1167411309 1167431309 1167441309 1167451309 1167461309 1013301309 1014161309 1013311309 1014171309 1013331309 1014191309 1013351309 1014231309 1013391309 1014251309 1013411309 1014261309 1013431309 1014281309 1013451309 1014301309 1013511309 1014321309 1013531309 1014341309 1013551309 1014351309 1013561309 1083721309 1013571309 1083731309 1013581309 1083751309 1013601309 1083851309 1013611309 1083871309 1013621309 1083881309 1013641309 1083891309 1013661309 1083901309 1013701309 1083911309 1013721309 1083921309 1013741309 1083931309 1013761309 1083991309 1013771309 1084021309 1013791309 1084061309 1013811309 1084081309 1013821309 1084091309 1013831309 1084111309 1013841309 1084121309 1013851309 1084131309 1013861309 1084141309 1013871309 1084151309 1013891309 1084161309 1013921309 1084171309 1013941309 1084181309 1013961309 1084191309 1013981309 1084201309 1014021309 1084211309 1014051309 1084221309 1014071309 1084231309 1014091309 1084241309 1014121309 1084251309 1014131309 1084261309 1014141309 1084271309 1014151309 1084281309 1084291309 1084301309 1084311309 1084321309 1084341309 1084361309 1084381309 1084391309 1084401309 1084411309 1084421309 1084441309 1084461309 1084481309 1084491309 1217341310 1217391310 1217421310 1217441310 1217461310 1217481310 1217521310 1217541310 1217561310 1217581310 1217601310 1217621310 1217801310 1217811310 1004031311 1004051311 1042501309 1042521309 1042531309 1042551309 1042811309 1166521309 1166571309 1166611309 1013491309 1083711309 1083771309 1216881310
• Recalling Firm/ Manufacturer: AMO Puerto Rico Manufacturing, Inc.; Rd # 402, Km 4.2; Anasco PR 00610
• Manufacturer Reason for Recall: Units may be labeled with the incorrect diopter power.
• FDA Determined Cause: Error in labeling
• Action: AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.
• Quantity in Commerce: 77,055 IOLs in total
• Distribution: Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
• 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.