FDAFDA · Food and drugs·Recall number Z-2274-2014
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.
Published August 27, 2014 · Recall initiated: May 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Units may be labeled with the incorrect diopter power.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Distributor
- Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
- Lot
- 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 1221641309 1017191311 1036591309 1190661309 1221151309 1221651309 1017211311 1036601309 1190681309 1221171309 1221661309 1017231311 1036611309 1190701309 1221181309 1221671309 1020891311 1036621309 1190721309 1221191309 1221681309 1020901311 1036631309 1190751309 1221201309 1221691309 1021091311 1036641309 1190761309 1221211309 1221701309 1021201311 1036651309 1190771309 1221221309 1221721309 1021221311 1036671309 1190781309 1221231309 1221741309 1021241311 1036691309 1190791309 1221241309 1221761309 1021261311 1036751309 1190891309 1221251309 1221801309 1021281311 1036871309 1190931309 1221261309 1221821309 1021301311 1036951309 1191031309 1221271309 1221841309 1021321311 1036981309 1191061309 1221281309 1221861309 1021341311 1037001309 1191081309 1221291309 1221871309 1021361311 1037021309 1191101309 1221311309 1221881309 1021381311 1037041309 1191171309 1221331309 1221901309 1021401311 1037061309 1191181309 1221351309 1221921309 1021421311 1037071309 1191191309 1221361309 1221941309 1036181309 1037091309 1191211309 1221371309 1221951309 1036201309 1037111309 1191231309 1221381309 1221961309 1036221309 1190391309 1191271309 1221391309 1221971309 1036241309 1190411309 1191291309 1221401309 1221981309 1036271309 1190421309 1191311309 1221411309 1222001309 1036281309 1190431309 1191331309 1221421309 1222021309 1036291309 1190441309 1191351309 1221431309 1222031309 1036311309 1190451309 1191371309 1221441309 1222041309 1036321309 1190461309 1191391309 1221451309 1222061309 1222081309 1018561311 1019201311 1049981309 1108671309 1109161309 1227091309 1018571311 1019221311 1050201309 1108681309 1109201309 1227101309 1018581311 1019231311 1050221309 1108691309 1109221309 1227121309 1018591311 1019241311 1050241309 1108701309 1109241309 1227141309 1018601311 1019251311 1050261309 1108711309 1109251309 1227151309 1018611311 1019271311 1050271309 1108721309 1109271309 1227171309 1018621311 1019291311 1050281309 1108731309 1109281309 1227191309 1018641311 1019311311 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 122741
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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