12156526 12156527 12156528 12156529 12156530 12156531 12158162 12158163 12158164 12158165 12158166 12161289 12161290 12161291 12161292 12161293 12161294 12161295 12161296 12161297 12161298 12161299 12165173 12165174 12165175 12165176 12165179 12165187 12165188 12165192 12165193 12199362 12199363 12199365 12199367 12205570 12205881 12205882 12205883 12205884 12205885 12205886 12205887 12205888 12205889 12205890 12205891 12208850 12208851 12208852 12208853 12208854 12208855 12208856 12208857 12208858 12208859 12208860 12208861 12208862 12216598 12220884 12220956 12220957 12223717 12224422 12224753 12224754 12224755 12224756 12224757 12225701 12230266 12230895 12230896 12230897 12231907 12233505 12233506 12233507 12235083 12238380 12238381 12238382 12238383 12238384 12238385 12238386 12238387 12238388 12238389 12238390 12238391 12238397 12238398 12241033 12241034 12241338 12241339 12241340 12241341 12241342 12241343 12241344 12241345 12241346 12243953 12245144 12245145 12245163 12245164 12245165 12245166 12245167 12245168 12245169 12245170 12245171 12245172 12246221 12247472 12247473 12247474 12247475 12247476 12249098 12249099 12249100 12249101 12250139 12250944 12251348 12251349 12254704 12258373 12261857 12261858 12261859 12261860 12261861 12261862 12261863 12261864 12261865 12267813 12267814 12267815 12267816 12267817 12267818 12267819 12269093 12269094 12269095 12269096 12272159 12272160 12272161 12272162 12272163 12272164 12273173 12273174 12273175 12273176 12273177 12273178 12273179 12273180 12273181 12273182 12273183 12274561 12274562 12275464 12275465 12275466 12275467 12275468 12275469 12275470 12275471 12276613 12276614 12276615 12280534 12280535 12280536 12280537 12280538 12280539 12280540 12280541 12280542 12280543 12280544 12280545 12285570 12285571 12285572 12285573 12285574 12285575 12285576 12288202 12290298 12290362 12290363 12290364 12290365 12290366 12290367 12290368 12290369 12290370 12302748 12302749 12302750 12302751 12302752 12302753 12302754 12302755 12322799 12322800 12330979 12330981 12330982 12330983 12330984 12330985 12330986 12335930 12335931 12335932 12335933 12335934 12335935 12335936 12335937 12335938 12335939 12335940 12335941 12345478 12345479 12345480 12345481 12345482 12345483 12345484 12345485 12345486 12350832 12350833 12350834 12350835 12350836 12350837 12350838 12350839 12350840 12350841 12350842 12350843 12350844 12350845 12350846 12350847 12350848 12353523 12356442 12356443 12356444 12356445 12356446 12356447 12356448 12356449 12363284 12363285 12363286 12363287 12363288 12363289 12372557 12372558 12372559 12372560 12378963 12378964 12378965 12378966 12378967 12378968 12378969 12378971 12378972 12378973 12378974 12378975 12378976 12383974 12383975 12383976 12383977 12383978 12383979 12383980 12383981 12383982 12383983 12383984 12383985 12385737 12388578 12388579 12389823 12389824 12389825 12389826 12389827 12389828 12391348 12398504 12398505 12398506 12156532 12156533 12156534 12156535 12156536 12158168 12158169 12158170 12158171 12161300 12161301 12161302 12161303 12161304 12161305 12161306 12161308 12161309 12161310 12165206 12165208 12199368 12199370 12199371 12199372 12199373 12205892 12205893 12205894 12205895 12205896 12205897 12205898 12205899 12205900 12205901 12205902 12205903 12208863 12208864 12208865 12215579 12215580 12216599 12216600 12216601 12216602 12219247 12220885 12220886 12220887 12220888 12224423 12224758 12224759 12225702 12230267 12230268 12230269 12230898 12238392 12238399 12241035 12241347 12243954 12243955 12243956 12245146 12245173 12246222 12249102 12249103 12249111 12249112 12251350 12251351 12251352 12251353 12251354 12251355 12251356 12258374 12261630 12261866 12267820 12267821 12267822 12267823 12268019 12272165 12272166 12272167 12272168 12272169 12272170 12272171 12272172 12272173 12272174 12272175 12275472 12275473 12275474 12280546 12280547 12280548 12280549 12280550 12283878 12285410 12285577 12285578 12285579 12285580 12285581 12285582 12285583 12285584 12285585 12285586 12290371 12298992 12298993 12298994 12298995 12302068 12302756 12302757 12302758 12302759 12302760 12308160 12322801 12322802 12330987 12335942 12335943 12335944 12335945 12345487 12349079 12350849 12350850 12350851 12350852 12350853 12350854 12350855 12353524 12356450 12356451 12356452 12356453 12356454 12360181 12363290 12363291 12363292 12363293 12372561 12372562 12372563 12372564 12372565 12378977 12378978 12378979 12378980 12378981 12378982 12378983 12378984 12378985 12378986 12380542 12383986 12383987 12383988 12383989 12389830 12389831 12389832 12389833 12398514 12156537 12156611 12156612 12156613 12156614 12158172 12158174 12158176 12161311 12161312 12161313 12161314 12161315 12161316 12161317 12161318 12161319 12161703 12161704 12173557 12199374 12205572 12205904 12205905 12205906 12205907 12205908 12216603 12216604 12220889 12230899 12230900 12238393 12241036 12241037 12241038 12241039 12241348 12241349 12241350 12245147 12245174 12250945 12251357 12261867 12261868 12267824 12267825 12271718 12272176 12272747 12275475 12275476 12275477 12275478 12278172 12280551 12280552 12280553 12290299 12297182 12302069 12302070 12316241 12316242 12322803 12322804 12330988 12330989 12335946 12335947 12335948 12335949 12335950 12345488 12350856 12350857 12350858 12350859 12350860 12350861 12350862 12353525 12356455 12356456 12356457 12356458 12372566 12378987 12378988 12378989 12378990 12378991 12383990 12388580 12389834 12393032 12398516 12398517 12398519 12156538 12156615 12156616 12156617 12156618 12158177 12158178 12158179 12158180 12158181 12161320 12161321 12161322 12161324 12161325 12161326 12161327 12161328 12161705 12161706 12199375 12205909 12205910 12208866 12208867 12216605 12216606 12220958 12230270 12230901 12230902 12230903 12231908 12233508 12238394 12238395 12238396 12241040 12241351 12241352 12241353 12241354 12243957 12245148 12245149 12250946 12250947 12257837 12257838 12261631 12261632 12261633 12261869 12261870 12261871 12270533 12270534 12271719 12272177 12272748 12275479 12275480 12276616 12280554 12280555 12285587 12290300 12290372 12290373 12298996 12298997 12298998 12298999 12302071 12302761 12302762 12302763 12308161 12316243 12330990 12330991 12335951 12335952 12335953 12335954 12335955 12349080 12350863 12350864 12350865 12350866 12350867 12350868 12350869 12350870 12356459 12356460 12356461 12360182 12360183 12372568 12372569 12372570 12378992 12378993 12383992 12383993 12383994 12398521 12398522

Ophthalmic Devices

3

Yes

International Only Distribution -- Japan.

Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. || Intended for primary implantation in the capsular bag of the eye for visual correction.

Model Numbers(s): AO60 and MI60L

Ophthalmic Devices

3

Yes

Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.

Bausch & Lomb AKREOS AO Micro Incision Lens || The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.

Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028

Ophthalmic Devices

3

Yes

Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***

Alcon AcrySof IQ IOL with ULTRASERT Delivery System || Product Usage: || The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.

CeeOn¿ EDGE Silicone 911A, 189 lenses  SLMP 911A +10,0 8131520508 SLMP 911A +11,5 8116020508  8116050508  8116060508 SLMP 911A +13,0 8189380508 SLMP 911A +13,5 8108000508 SLMP 911A +14,0 8033720508  8090160508  8224980508 SLMP 911A +15,0 8105650508  8105660508  8105680508  8105690508  8105730508  8105740508  8105760508  8105770508  8105790508 SLMP 911A +15,5 8064660508  8064800508  8186100508  8186110508 SLMP 911A +16,5 8063190508  8063270508  8063280508  8063290508  8063300508  8063310508 SLMP 911A +17,0 8062880508  8062920508  8062960508  8062970508  8062980508  8063000508  8236490508 SLMP 911A +17,5 8047590508  8047830508 SLMP 911A +18,0 8058440508  8058450508  8058460508  8058470508  8058490508  8058500508  8058520508 SLMP 911A +18,5 8058030508  8058110508  8058350508  8058360508  8139110508  8139150508 SLMP 911A +19,5 8047170508  8047180508  8047200508  8047210508  8047220508  8047250508  8047340508  8047360508 SLMP 911A +21,5 8082640508  8082660508  8082670508  8082680508  8082740508  8082750508  8082760508  8082770508  8082780508  8082920508  8084420508  8084670508 SLMP 911A +22,0 8056570509  8056590509  8164620508 SLMP 911A +22,5 8081650508  8081710508  8081770508  8081790508  8081820508  8081830508  8081840508  8081850508  8081860508  8081870508  8108460508  8108470508  8108500508  8108510508  8108520508  8108560508  8108650508  8165340508  8165350508  8165360508  8165370508  8165380508  8165390508  8165400508  8165410508  8165420508  8165430508 SLMP 911A +23,0 8085040508  8085050508  8085060508  8085080508  8085090508  8085100508  8085120508  8085130508  8085140508  8085150508  8085160508  8085170508  8085180508  8085190508  8085220508  8085230508  8086900508  8086910508  8086920508  8086930508  8086940508  8087040508  8087050508  8087060508  8087070508  8087080508  8176340508 SLMP 911A +24,0 8089850508  8089910508  8175230508  8175260508  8194110508  8194120508  8194130508  8194140508  8194160508  8194180508  8194820508  8194910508  8194950508  8195360508  8195370508  8195410508  8195470508  8195520508 SLMP 911A +24,5 8084090508  8084100508  8084200508  8089000508  8168060508 SLMP 911A +25,0 8067040508  8067300508 SLMP 911A +25,5 8084740508  8084770508  8084780508  8084790508  8084940508  8084950508  8092820508 SLMP 911A +26,5 8100530508  8100540508  8100560508  8100640508  8100660508 SLMP 911A +27,0 8099340508  8099380508 SLMP 911A +28,0 8085670508  8085950508  8085960508 SLMP 911A +28,5 8077790508  8077860508  8102970508  8103030508  8103040508  8103080508  8103090508  8103100508  8103120508  8103130508  8103140508 SLMP 911A +29,0 8096860508  8096900508 SLMP 911A +29,5 8095320508  8095330508 SLMP 911A +30,0 8106430508  8106440508  8106450508  8106460508  8106470508  CeeOn¿ EDGE Silicone 913A, 103 lenses   SLMP 913A +11,0 8184650508 SLMP 913A +15,5 8171590508 SLMP 913A +18,5 8177910508  8177920508  8177960508  8177970508  8178040508 SLMP 913A +19,0 8053490508  8053520508  8053530508  8181070508 SLMP 913A +19,5 8052440508  8052460508  8052470508  8052480508  8052680508 SLMP 913A +20,0 8053300508 SLMP 913A +20,5 8245300508  8245310508  8245320508  8245330508  8245340508  8245350508  8245370508  8245420508  8245430508  8245440508  8245450508  8245460508  8245470508  8245540508  8245570508 SLMP 913A +21,0 8179350508  8179360508  8179370508  8179380508  8179390508  8179400508  8179450508  8179460508  8183440508  8183520508  8183540508  8183550508  8183560508  8183570508  8183580508 SLMP 913A +22,0 8035910509  8070510508  8180690508  8180700508  8180710508  8180720508  8180730508  8180740508  8180750508  8180760508  8180770508 SLMP 913A +22,5 8227980508  8227990508  8228000508  8228010508  8228020508  8228050508  8228200508  8228210508  8228220508 SLMP 913A +23,0 8227170508  8227210508  8227220508  8227240508  8227250508  8227260508  8227270508 SLMP 913A +23,5 8077180508  8077230508  8077240508  8077280508  8180250508  8180260508 SLMP 913A +24,0 8176510508  8176520508  8176530508  8176540508  8176550508  8176560508  8176570508  8176580508  8176590508  8176600508  8176610508  8176620508  8181330508  8181380508  8181390508  8181400508 SLMP 913A +24,5 8078360508  8178480508  8178680508  8178690508 SLMP 913A +25,0 8182890508  8182900508  8182930508

Ophthalmic Devices

3

Yes

Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam

CeeOn EDGE Silicone || Posterior Chamber IOLs || (Modelsl 911A and 913A)

CeeOn¿ One-Piece PMMA 722C, 10 lenses  PMMA HSM 722C +19,5 8094420508  8094430508  8094440508 PMMA HSM 722C +22,5 8032640508  8032830508  8032840508  8032850508 PMMA HSM 722C +23,0 8266000508 PMMA HSM 722C +23,5 8217920508 PMMA HSM 722C +28,5 8221020508  CeeOn¿ One-Piece PMMA 722Y, 2 lenses  PMMA HSM 722Y +29,0 8136600508  8136610508  CeeOn¿ One-Piece PMMA 811C, 1 lens  PMMA HSM 811C +22,0 8054190508  CeeOn¿ One-Piece PMMA 812CU, 4 lenses  PMMA HSM 812CU+17,5 8139760508 PMMA HSM 812CU+23,0 8156200508  8156210508  8156220508

Ophthalmic Devices

3

Yes

Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam

CeeOn Heparin Surface || Modified (HSM) PMMA One-Piebe Posterior Chambet- IOLs (Models:722C, 722Y, 811C, 812C and 812CU)

CeeOn¿ One-Piece PMMA HSM65, 2 lenses  PMMA HSM HSM65+22,0  8054720508 8054730508

Ophthalmic Devices

3

Yes

Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam

CeeOn Heparin SurfaceModifie (HSM) PMMA || One-Piece Anterior Chamber IOLs (Model: HSM65)

No codes apply

Ophthalmic Devices

3

Yes

Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.

Collamer UV One-Piece IntraOcular Lens. || Models 4205BF and 4204BF

Ophthalmic Devices

Yes

Non-active implants - other implants

Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.

Ophthalmic Devices

3

Yes

Distributed in the states of OK, KS, FL, and AL.

Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.

Lot Numbers: 1829803, 1829803, 1829814, 1829823 and 1829824.

Ophthalmic Devices

3

Yes

Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.

Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.

Serial No. 1104621505 1164491602 1164501602 1164511602 1164521602 1164541602 1164551602 1164561602 1164571602 1164581602 1164601602 1164611602 1164621602 1164641602 1164651602 1164711602 1074911602 1074921602 1074931602 1074941602 1074951602 1074961602 1074971602 1074981602 1074991602 1075001602 1075011602 1075021602 1075031602 1075041602 1075051602 1075061602 1075071602 1075081602 1075091602 1075101602 1075111602 1075131602 1075141602 1075151602 1075121602

Ophthalmic Devices

3

Yes

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

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 || 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.

All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910.  Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10

Ophthalmic Devices

3

Yes

AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, Hawaii, and Puerto Rico. INTERNATIONAL: Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa.

AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)

Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605

Ophthalmic Devices

3

Yes

Worldwide, including USA (CT, TX, NY), Canada, and UK.

AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310 1000691310 1231001309 1231601309 1000101310 1000401310 1000701310 1231011309 1231311309 1231611309 1000111310 1000411310 1000711310 1231021309 1231321309 1231621309 1000121310 1000421310 1000721310 1231031309 1231331309 1231631309 1000131310 1000431310 1000731310 1231641309 1000141310 1000441310 1000741310 1231051309 1231351309 1231651309 1000151310 1000451310 1000751310 1231061309 1231361309 1231661309 1000161310 1000461310 1000761310 1231071309 1231371309 1000171310 1000471310 1000771310 1231081309 1231381309 1231681309 1000181310 1000481310 1000781310 1231091309 1231391309 1000191310 1000491310 1000791310 1231101309 1231401309 1231701309 1000201310 1000501310 1000801310 1231111309 1231411309 1231711309 1000211310 1000811310 1231121309 1231421309 1231721309 1000221310 1000521310 1000821310 1231131309 1231431309 1000231310 1000531310 1000831310 1231141309 1231441309 1231741309 1000241310 1000541310 1231151309 1231451309 1231751309 1000251310 1000551310 1231161309 1231461309 1231761309 1000261310 1000561310 1231171309 1231471309 1231771309 1000271310 1000571310 1231181309 1231481309 1231781309 1000281310 1000581310 1231191309 1231491309 1231791309 1000291310 1000591310 1231501309 1231801309

Ophthalmic Devices

3

Yes

Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. || Indicated for primary implantation for the visual correction of aphakia in adult patients.

8XRJ

Ophthalmic Devices

3

Yes

Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.

SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.

Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939

Ophthalmic Devices

2

Yes

Internationally to Finland & France

Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

Lot/Unit Codes: 32764, 35906, 35907, 35908, 36307, 36308, 36309, 36315, 36316, 36364, 36430, 36431, 36469, 36470, 36471, 36476, 49216, 54304, 54569, 63449, 63450, 63710, 63803.

Ophthalmic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore.

Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. || Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. || Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. || Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in || implant insertion and provides a means of securing muscles to the implant. || The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.

model number 14166. lot number 1218

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Large (Sterile)

model number 14165. lot number 1187

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Medium (Sterile)

model number 14169. lot number 1235

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Large with holes (Sterile)

model number 14168. lot number 1234

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Medium with holes (Sterile)

model number 14164. lot number 8264B

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Small (Sterile)

model number 14167. lot number 1233

Ophthalmic Devices

2

Yes

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Conformer - Small with holes (Sterile)

Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016

Ophthalmic Devices

3

Yes

Nationwide Distribution

Crystalens¿ Accommodating Posterior Chamber Intraocular Lens, AT-50AO. || Crystalens¿ Accommodating Posterior Chamber Intraocular Lens || PMA No.: P030002. || The Crystalens¿ is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.

This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 7355 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.

Ophthalmic Devices

3

Yes

Nationwide Distribution

iSert Intraocular Lens (Model PC-60AD)