Device Recall TECNIS

ZKB00 Serial No. 8667461602  8667751602 8667471602  8667761602 8667481602  8667771602 8667491602  8667781602 8667501602  8667801602 8667511602  8667811602 8667521602  8667821602 8667531602  8667831602 8667541602  8667841602 8667551602  8667851602 8667561602  8667861602 8667571602  8667871602 8667581602  8667881602 8667591602  8667891602 8667601602  8667901602 8667611602  8667911602 8667621602  8667921602 8667631602  8667931602 8667641602  8667961602 8667661602  8667971602 8667671602  8667981602 8667681602  8667991602 8667691602  8668001602 8667701602  8668011602    ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506

Ophthalmic Devices

3

Yes

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; || The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

Serial No. 8618391605 8618441605 8231911605 8231921605 8231931605 8231961605 8496921508 8496931508 8496941508 8496951508

Ophthalmic Devices

3

Yes

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 || The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

Serial No. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206

Ophthalmic Devices

3

Yes

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

TECNIS 1-Piece IOL, Model No. ZCB00 || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

Serial No. 7138841403 2648831412 2648971412 2649011412 2649071412 2649101412 2649181412 2649221412 2649241412 2649261412 2649281412 2649301412 7138301403 7138311403 7138321403 7138331403 7138341403 7138351403 7138361403 7138371403 7138381403 7138391403 7138401403 7138411403 7138431403 7138441403 7138451403 7138461403 7138471403 7138481403 7138491403 7138501403 7138511403 7138521403 7138531403 7138541403 7138551403 7138561403 7138571403 7138581403 7138591403 7138601403 7138611403 7138621403 7138631403 7138641403 7138651403 7138661403 7138671403 7138681403 7138691403 7138701403 7138711403 7138721403 7138731403 7138741403 7138751403 7138761403 7138771403 7138781403 7138791403 7138801403 7138811403 7138821403 7138831403 7138851403 7138881403 7138891403 7138901403 7138911403 7138921403 7138941403 7138951403 7138961403 7138971403 7138981403 7138991403 7139001403 7139011403 7139021403 7139031403 7139041403 7139051403 7139061403 7139071403 7139081403 7139091403 7139101403 7139111403 7139121403 7139131403 7139141403 2648751412 2648761412 2648771412 2648781412 2648791412 2648801412 2648811412 2648821412 2648841412 2648851412 2648861412 2648871412 2648881412 2648891412 2648901412 2648911412 2648921412 2648931412 2648941412 2648951412 2648961412 2648981412 2648991412 2649001412 2649021412 2649031412 2649041412 2649061412 2649081412 2649091412 2649111412 2649121412 2649131412 2649141412 2649151412 2649161412 2649171412 2649191412 2649201412 2649211412 2649231412 2649251412 2649271412 2649291412 2649311412 2397761605 2397981605 3125171501 3125181501 7731731310 7731741310 7731751310 7731761310 7731771310 7731781310 7731791310 7731801310 7731811310 7731821310 7731831310 7731841310 7731851310 7731861310 7731871310 7731881310 7731891310 7731901310 7731911310 7731921310 7731931310 7731941310 7731951310 7731961310 7731971310 7731981310 7731991310 7732001310 7732011310 7732021310 7732031310 7732041310 7732051310 7732061310 7732071310 7732081310 7732091310 7732101310 7732121310 7732131310 7732141310 7732151310 7732161310 7732181310 7732191310 7732201310 7732211310 7732221310 7732231310 7732241310 7732251310 7732261310 7732271310 7732281310 7732291310 7732301310 7732311310 7732321310 7732331310 7732341310 7732361310 7732371310 7732391310 7732401310 7732411310 7732421310 7732431310 7732441310 7732451310 7732461310 7732471310 7732481310 7732491310 7732501310 7732511310 7732521310

Ophthalmic Devices

3

Yes

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

Serial No. 5860621403 5860631403 5860641403 5860651403 5860661403 5860671403 5860681403 5860691403 5860701403 5860711403 5860721403 5860731403 5860741403 5860751403 5860771403 5860781403 5860791403 5860801403 5860811403 5860821403 5860831403 5860851403 5860871403 5860881403 5860891403 5860901403 5860911403 5860921403 5860931403 5860941403 5860951403 5860961403 5860971403 5860981403 5860991403 5861001403 5861011403 5861021403 5861031403 5861041403 5861051403 5861061403 5861081403 5861091403 5861101403 5861111403 5861391403 5861401403 5861411403 5861421403 5861431403 5861441403 5861451403 5861461403 5861471403 5861481403 5861491403 5861501403 5861511403 5861521403 5861531403 5861541403 5861551403 5861561403 5861581403 5861591403 5861601403 5861611403 5861621403 5861631403

Ophthalmic Devices

3

Yes

Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery || System, Model No. PCB00V || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag