FDAFDA · Food and drugs·Recall number Z-2278-2014
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: 16.5, 17.0 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
- 1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309 1031881311 1032441311 1041231312 1041771312 1042221312 1048421311 1006381309 1006961309 1031891311 1032461311 1041241312 1041781312 1042231312 1048441311 1006391309 1006981309 1031901311 1032481311 1041251312 1041791312 1042241312 1048461311 1006401309 1007001309 1031911311 1032501311 1041261312 1041801312 1042251312 1048481311 1006411309 1007021309 1031921311 1032521311 1041271312 1041811312 1047821311 1048501311 1006421309 1007031309 1031931311 1032541311 1041281312 1041821312 1047841311 1048511311 1006431309 1007041309 1031941311 1032561311 1041291312 1041831312 1047861311 1048521311 1006441309 1007061309 1031951311 1032581311 1041301312 1041841312 1047881311 1048531311 1006451309 1007071309 1031961311 1032591311 1041311312 1041851312 1047901311 1048541311 1006471309 1007081309 1031971311 1032601311 1041321312 1041861312 1047911311 1048551311 1006491309 1007091309 1031981311 1032611311 1041331312 1041871312 1047931311 1048561311 1006511309 1007101309 1031991311 1032621311 1041341312 1041881312 1047951311 1048571311 1006561309 1007111309 1032001311 1032631311 1041351312 1041891312 1047971311 1048581311 1006571309 1007121309 1032011311 1032641311 1041361312 1041901312 1047991311 1048591311 1006581309 1007131309 1032021311 1032651311 1041371312 1041911312 1048011311 1048601311 1006601309 1007151309 1032031311 1032661311 1041381312 1041921312 1048051311 1048611311 1006621309 1007161309 1032041311 1032671311 1041391312 1041931312 1048061311 1048621311 1006631309 1007171309 1032051311 1032681311 1041401312 1041941312 1048071311 1048631311 1006641309 1007181309 1032061311 1032691311 1041411312 1041951312 1048081311 1048641311 1006651309 1007191309 1032071311 1032701311 1041431312 1041961312 1048091311 1048651311 1006661309 1007201309 1032081311 1032711311 1041451312 1041971312 1048111311 1048661311 1006671309 1007211309 1032091311 1032721311 1041471312 1041981312 1048121311 1048671311 1006681309 1007221309 1032101311 1032731311 1041491312 1041991312 1048131311 1048691311 1006691309 1007231309 1032111311 1032741311 1041501312 1042001312 1048151311 1048751311 1006701309 1007241309 1032121311 1032751311 1041511312 1042011312 1048161311 1050011311 1006711309 1007251309 1032131311 1032761311 1041521312 1042021312 1048171311 1050021311 1006721309 1007261309 1032151311 1032771311 1041531312 1042031312 1048181311 1050041311 1006731309 1007271309 1032171311 1032781311 1041541312 1042041312 1048191311 1050061311 1006741309 1007281309 1032181311 1032791311 1041551312 1042051312 1048201311 1050071311 1006751309 1007301309 1032191311 1032801311 1041561312 1042061312 1048211311 1050081311 1006761309 1007321309 1032201311 1032811311 1041571312 1042071312 1048231311 1050091311 1006781309 1007341309 1032221311 1032821311 1041581312 1042081312 1048241311 1050111311 1006791309 1031741311 1032241311 1032831311 1041591312 1042091312 1048251311 1050131311 1006801309 1031751311 1032261311 1041111312 1041601312 1042101312 1048261311 1050151311 1006821309 1031761311 1032281311 1041121312 1041611312 1042111312 1048281311 1050171311 1006841309 1031771311 1032291311 1041131312 1041621312 1042121312 1048301311 1050191311 1006851309 1031781311 1032301311 1041141312 1041631312 1042131312 1048311311 1050211311 1006861309 1031791311 1032311311 1041151312 1041641312 1042141312 1048321311 1050231311 1006871309 1031801311 1032321311 1041161312 1041661312 1042151312 1048331311 1050251
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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