FDAFDA · Food and drugs·Recall number Z-2275-2014
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: 13.0, 13.5, 14.0 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
- 1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310 1214401310 1262721310 1290531308 1030831310 1031351310 1113031309 1113561309 1213891310 1214421310 1262731310 1290541308 1030841310 1031361310 1113051309 1113571309 1213911310 1214441310 1262751310 1290551308 1030861310 1031371310 1113071309 1113581309 1213921310 1214461310 1262771310 1290561308 1030871310 1031381310 1113091309 1113601309 1213941310 1214481310 1262781310 1290571308 1030881310 1031391310 1113101309 1113621309 1213951310 1214491310 1262791310 1290581308 1030891310 1031401310 1113111309 1113661309 1213961310 1214501310 1262801310 1290591308 1030901310 1031411310 1113121309 1113681309 1213971310 1214511310 1262811310 1290601308 1030911310 1031421310 1113131309 1113701309 1213981310 1214521310 1262821310 1290611308 1030921310 1031431310 1113141309 1113711309 1213991310 1214531310 1262831310 1290621308 1030931310 1031451310 1113151309 1113721309 1214001310 1214541310 1262851310 1290631308 1030941310 1031471310 1113161309 1113731309 1214011310 1214561310 1262871310 1290641308 1030951310 1031491310 1113171309 1113741309 1214021310 1214571310 1262891310 1290651308 1030961310 1031511310 1113181309 1113761309 1214031310 1214581310 1262911310 1290661308 1030971310 1031521310 1113191309 1113781309 1214041310 1214591310 1262931310 1290671308 1030981310 1031531310 1113201309 1113791309 1214051310 1214601310 1262951310 1290681308 1030991310 1031541310 1113211309 1113801309 1214061310 1214611310 1262971310 1290701308 1031001310 1031551310 1113221309 1113811309 1214071310 1214621310 1262991310 1290721308 1031011310 1031561310 1113231309 1113821309 1214081310 1214641310 1263011310 1290741308 1031021310 1031571310 1113241309 1113831309 1214101310 1214661310 1263031310 1290761308 1031041310 1031581310 1113251309 1113841309 1214121310 1214671310 1263051310 1290781308 1031051310 1031591310 1113261309 1113851309 1214131310 1262261310 1263071310 1290791308 1031061310 1031601310 1113271309 1113861309 1214141310 1262281310 1263091310 1290801308 1031071310 1031611310 1113281309 1113881309 1214151310 1262301310 1263101310 1290811308 1031081310 1031621310 1113301309 1113901309 1214161310 1262321310 1263111310 1290821308 1031091310 1031631310 1113311309 1113921309 1214171310 1262341310 1263121310 1290831308 1031101310 1031651310 1113321309 1127501312 1214181310 1262351310 1263131310 1290841308 1031111310 1031671310 1113331309 1127641312 1214191310 1262361310 1263151310 1290851308 1031121310 1031691310 1113341309 1128211312 1214201310 1262371310 1263161310 1290861308 1031131310 1031711310 1113351309 1128231312 1214211310 1262381310 1263171310 1290871308 1031141310 1031731310 1113361309 1213691310 1214221310 1262401310 1263191310 1290881308 1031151310 1031741310 1113371309 1213701310 1214231310 1262411310 1263211310 1290891308 1031161310 1031751310 1113381309 1213711310 1214241310 1262421310 1263231310 1290901308 1031171310 1031761310 1113391309 1213721310 1214251310 1262431310 1263291310 1290911308 1031191310 1031771310 1113401309 1213731310 1214271310 1262441310 1290391308 1290921308 1031211310 1031781310 1113411309 1213741310 1214291310 1262461310 1290401308 1290931308 1031231310 1031801310 1113421309 1213751310 1214301310 1262481310 1290411308 1290941308 1031251310 1112841309 1113431309 1213761310 1214311310 1262501310 1290421308 1290951308 1031261310 1112851309 1113441309 1213771310 1214321310 1262521310 1290431308 1290961308 1031271310 1112871309 1113461309 1213781310 1214331310 1262541310 1290441308 1290971308 1031281310 1112901309 1113481309 1213791310 1214341310 1262561310 1290461308 1290981308 1031291310 1112931309 1113501309 1213811310 1214351310 1262581310 1290481308 1290991308 1031301310 1112951309 1113511309 1213821310 1214361310 1262621310 1290501308 1291001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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