FDAFDA · Alimentos y medicamentos·N.º oficial Z-2285-2014
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: 24.5, 25, 25.5 & 26. 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.
Publicado el 27 de agosto de 2014 · Inicio del retiro: 13 de mayo de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Units may be labeled with the incorrect diopter power.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- AMO Puerto Rico Manufacturing, Inc.
- Distribuidor
- Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
- Lote
- Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311 1004991311 1005001311 1005021311 1005041311 1005061311 1005071311 1005091311 1005111311 1005121311 1005151311 1005161311 1005171311 1005181311 1005191311 1005201311 1005211311 1005221311 1005231311 1005241311 1005251311 1005291311 1005331311 1005351311 1005521311 1005531311 1005541311 1005551311 1005561311 1005571311 1005591311 1005611311 1005651311 1005711311 1005731311 1005751311 1005771311 1005791311 1005811311 1005831311 1005841311 1005851311 1014291310 1014301310 1014311310 1014411310 1014421310 1014431310 1014451310 1014511310 1014521310 1014531310 1014541310 1014561310 1014581310 1014591310 1014601310 1014611310 1014641310 1014661310 1014671310 1014701310 1014721310 1014781310 1014801310 1014811310 1014831310 1014861310 1014881310 1014891310 1014911310 1014921310 1014931310 1014951310 1014971310 1014981310 1014991310 1015001310 1015011310 1015021310 1015031310 1015051310 1015061310 1015071310 1015081310 1015091310 1015101310 1015111310 1015131310 1015141310 1015151310 1015171310 1015181310 1015191310 1015211310 1015231310 1015251310 1015271310 1015291310 1015311310 1015331310 1015341310 1020841310 1020851310 1020861310 1020871310 1020881310 1020891310 1020901310 1020911310 1020921310 1020931310 1020941310 1020951310 1020961310 1020971310 1020981310 1020991310 1021001310 1021021310 1021031310 1021041310 1021051310 1021061310 1021071310 1021081310 1021091310 1021101310 1021111310 1021121310 1021131310 1021141310 1021151310 1021161310 1021171310 1021181310 1021191310 1021201310 1021211310 1021221310 1021231310 1021241310 1021251310 1021261310 1021271310 1021281310 1021291310 1021301310 1021311310 1021321310 1021331310 1021341310 1021351310 1021361310 1021371310 1021381310 1021391310 1021401310 1021411310 1021421310 1021431310 1021441310 1021451310 1021461310 1021471310 1021481310 1021491310 1021501310 1021511310 1021521310 1021531310 1021541310 1021551310 1021561310 1021571310 1021581310 1021591310 1021601310 1021611310 1021621310 1021631310 1021641310 1021651310 1021671310 1021681310 1021691310 1021701310 1021711310 1021721310 1021731310 1021741310 1021751310 1021761310 1021771310 1021781310 1021791310 1021801310 1021811310 1021821310 1021831310 1021841310 1021851310 1021861310 1021871310 1021881310 1021891310 1021901310 1021941310 1021951310 1034081309 1034251309 1034311309 1034331309 1034351309 1034731309 1034751309 1034771309 1034791309 1034851309 1034871309 1034891309 1034911309 1034921309 1034931309 1034951309 1034971309 1034991309 1035011309 1035021309 1035031309 1035051309 1035061309 1035961311 1035971311 1036001311 1036011311 1036041311 1036051311 1036071311 1036081311 1036111311 1036121311 1036151311 1036161311 1036171311 1036191311 1036201311 1036231311 1036241311 1036281311 1036291311 1036311311 1036321311 1036331311 1036351311 1036361311 1036391311 1036401311 1036411311 1036431311 1036441311 1036451311 1036471311 1036481311 1036491311 1036511311 1036521311 1036551311 1036561311 1036591311 1036601311 1036631311 1036641311 1036681311 1036711311 1036721311 1036731311 1036741311 1036751311 1036781311 1036791311 1036821311 1036831311 1036871311 1036901311 1036911311 1036931311 1036951311 1036971311 1036991311 1037011311 1037021311 1037031311 1038921312 1044031309 1044041309 1044051309 1044061309 1044081309 1044091309 1044101309 1044111309 1044121309 1044141309 1044151309 1044161309 1044171309 1044181309 1044191309 1044201309 1044211309 1044221309 1044231309 1044
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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