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U.S. Department of Health and Human Services

Class 2 Device Recall TECNIS CL

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  Class 2 Device Recall TECNIS CL see related information
Date Initiated by Firm May 13, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on May 18, 2017
Recall Number Z-2274-2014
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: 12.0 and 12.5

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 1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871311 1036351309 1190491309 1191431309 1221481309 1016891311 1036371309 1190501309 1191441309 1221491309 1016911311 1036381309 1190511309 1191461309 1221501309 1016931311 1036401309 1190521309 1191471309 1221521309 1016951311 1036421309 1190531309 1191481309 1221531309 1016971311 1036431309 1190541309 1220991309 1221541309 1016991311 1036451309 1190551309 1221011309 1221551309 1017011311 1036461309 1190561309 1221021309 1221561309 1017031311 1036471309 1190571309 1221031309 1221571309 1017051311 1036491309 1190581309 1221041309 1221581309 1017071311 1036511309 1190591309 1221051309 1221591309 1017091311 1036521309 1190601309 1221061309 1221601309 1017111311 1036531309 1190611309 1221071309 1221611309 1017131311 1036541309 1190621309 1221081309 1221621309 1017151311 1036561309 1190631309 1221091309 1221631309 1017171311 1036581309 1190641309 1221111309 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1050301309 1108741309 1109291309 1227211309 1018651311 1019351311 1050321309 1108751309 1109311309 1227231309 1018661311 1019371311 1050341309 1108761309 1109331309 1227241309 1018671311 1019391311 1050361309 1108771309 1109351309 1227251309 1018691311 1019411311 1050381309 1108781309 1109371309 1227261309 1018711311 1019431311 1050401309 1108791309 1109391309 1227271309 1018731311 1019451311 1050421309 1108801309 1109411309 1227281309 1018751311 1019471311 1050491309 1108811309 1109431309 1227291309 1018771311 1019491311 1050511309 1108821309 1109451309 1227301309 1018781311 1019511311 1050531309 1108831309 1109471309 1227311309 1018791311 1019531311 1050541309 1108841309 1109481309 1227331309 1018801311 1019551311 1050561309 1108851309 1226581309 1227351309 1018811311 1019571311 1050581309 1108871309 1226601309 1227371309 1018821311 1019581311 1050601309 1108891309 1226641309 1227391309 1018831311 1019591311 1108421309 1108901309 1226661309 1227411309 1018841311 1019611311 1108431309 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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 2		 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.
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