FDAFDA · Food and drugs·Recall number Z-2286-2014
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: 26.5, 27, 27.5 & 28.5. 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
- Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309 1007571309 1007581309 1007591309 1007601309 1007611309 1007621309 1007631309 1007641309 1007651309 1007661309 1007671309 1007681309 1007691309 1007701309 1007711309 1007721309 1007731309 1007741309 1007751309 1007761309 1007771309 1007791309 1007801309 1007811309 1007821309 1007831309 1007841309 1007851309 1007861309 1007871309 1007881309 1007891309 1007901309 1007911309 1007921309 1007931309 1007941309 1007951309 1007961309 1007971309 1007981309 1007991309 1008001309 1008011309 1008021309 1008031309 1008041309 1008051309 1008061309 1008101309 1008121309 1008141309 1008161309 1008171309 1008181309 1008191309 1008201309 1008211309 1008221309 1008231309 1008241309 1008251309 1008261309 1008271309 1008281309 1008291309 1008301309 1008311309 1008321309 1008331309 1008341309 1008361309 1008381309 1008401309 1104951312 1119291309 1119311309 1119321309 1119331309 1119341309 1119351309 1119361309 1119371309 1119381309 1119391309 1119401309 1119411309 1119421309 1119431309 1119451309 1119461309 1119471309 1119481309 1119491309 1119501309 1119511309 1119521309 1119531309 1119541309 1119551309 1119561309 1119571309 1119581309 1119591309 1119601309 1119611309 1119621309 1119631309 1119641309 1119651309 1119661309 1119671309 1119681309 1119691309 1119701309 1119711309 1119721309 1119731309 1119741309 1119751309 1119771309 1119811309 1119831309 1119851309 1119871309 1119901309 1119921309 1119931309 1119941309 1119951309 1119971309 1119991309 1120001309 1120021309 1120041309 1120061309 1120081309 1120101309 1120121309 1120141309 1120161309 1120181309 1120201309 1120221309 1120251309 1120261309 1120271309 1120281309 1120331309 1120361309 1120371309 1120381309 1120391309 1120411309 1120421309 1217951310 1217971310 1217991310 1218011310 1218031310 1218051310 1218071310 1218091310 1218111310 1218131310 1218151310 1218171310 1218191310 1218211310 1218231310 1218251310 1218271310 1218291310 1218311310 1218331310 1218351310 1218361310 1218371310 1218381310 1218391310 1218411310 1218431310 1218451310 1218471310 1218491310 1218511310 1218531310 1218551310 1218571310 1218591310 1218611310 1218631310 1218651310 1218671310 1218691310 1218731310 1218751310 1218761310 1218771310 1218781310 1218791310 1218801310 1218811310 1218821310 1218831310 1218841310 1218851310 1218861310 1218871310 1218881310 1218891310 1218911310 1218921310 1218931310 1218941310 1236041309 1236051309 1236081309 1236091309 1236101309 1236121309 1236141309 1236161309 1236181309 1236191309 1236201309 1236211309 1236221309 1236231309 1236241309 1236251309 1236271309 1236281309 1236291309 1236301309 1236311309 1236321309 1236331309 1236341309 1236351309 1236361309 1236371309 1236381309 1236391309 1236401309 1236411309 1236421309 1236431309 1236451309 1236471309 1236491309 1236511309 1236531309 1236541309 1236551309 1236561309 1236571309 1236581309 1236591309 1236601309 1236611309 1236621309 1236631309 1236641309 1236651309 1236661309 1236671309 1236681309 1236691309 1236701309 1236711309 1236721309 1236731309 1236741309 1236751309 1236761309 1236771309 1236781309 1236791309 1236801309 1236811309 1236831309 1236851309 1236871309 1236901309 1236921309 1236941309 1236961309 1236991309 1237011309 1237021309 1237031309 1237051309 1237461310 1237471310 1237481310 1237491310 1237511310 1237521310 1237531310 1237551310 1237561310 1237581310 1237601310 1237611310 1237621310 1237631310 1237641310 1237651310 1237721310 1237741310 1237761310 1237
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.