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)

Model Number: LI61SE, Lot Number: 4916928.

Ophthalmic Devices

3

Yes

Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.

Bausch & Lomb SoFlex SE Foldable Intraocular Lens. || UPC 4001404, Rx Only, STERILE. || Manufactured by: || Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. || Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.

Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048

Ophthalmic Devices

2

Yes

USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey

Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

5185681009 5186101009 5185691009 5186111009 5185701009 5186121009 5185711009 5186131009 5185721009 5186141009 5185731009 5186151009 5185741009 5186161009 5185751009 5186171009 5185761009 5186181009 5185771009 5186191009 5185781009 5186201009 5185791009 5186211009 5185801009 5186221009 5185811009 5186231009 5185821009 5186241009 5185831009 5186251009 5185841009 5186261009 5185851009 5186271009 5185861009 5186281009 5185871009 5186291009 5185881009 5186301009 5185891009 5186311009 5185901009 5186321009 5185911009 5186331009 5185921009 5186341009 5185931009 5186351009 5185941009 5186361009 5185951009 5186371009 5185961009 5186381009 5185971009 5186391009 5185981009 5186401009 5185991009 5186411009 5186001009 5186421009 5186011009 5186431009 5186021009 5186441009 5186031009 5186451009 5186041009 5186461009 5186051009 5186471009 5186061009 5186491009 5186071009 5186501009 5186081009 5186511009 5186091009

Ophthalmic Devices

3

Yes

Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia

Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. || The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

5058981009 5059401009 5059831009  5058991009 5059411009 5059841009  5059001009 5059421009 5059851009  5059011009 5059431009 5059861009  5059021009 5059441009 5059871009  5059031009 5059451009 5059881009  5059041009 5059461009 5059891009  5059051009 5059471009 5059901009  5059061009 5059481009 5059911009  5059071009 5059491009 5059921009  5059081009 5059501009 5059931009  5059091009 5059511009 5059941009  5059101009 5059521009   5059111009 5059531009   5059121009 5059541009   5059131009 5059551009   5059141009 5059561009   5059151009 5059571009   5059161009 5059581009   5059171009 5059591009   5059181009 5059601009   5059191009 5059611009   5059201009 5059621009   5059211009 5059631009   5059221009 5059641009   5059231009 5059651009   5059241009 5059661009   5059251009 5059671009   5059261009 5059681009   5059271009 5059691009   5059281009 5059701009   5059291009 5059711009   5059301009 5059721009   5059311009 5059731009   5059321009 5059741009   5059331009 5059761009   5059341009 5059771009   5059351009 5059781009   5059361009 5059791009   5059371009 5059801009   5059381009 5059811009   5059391009 5059821009

Ophthalmic Devices

3

Yes

Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia

Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. || The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

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.

Tecnis¿ Silicone Z9000, 94 lenses   Tecnis Mono 12mm Z9000+11,5 8160800508 Tecnis Mono 12mm Z9000+23,0 8014050508 Tecnis Mono 12mm Z9000+12,0 8110100508 8014060508  8110110508 8014070508 Tecnis Mono 12mm Z9000+20,5 8095430509 8014090508 Tecnis Mono 12mm Z9000+21,0 8062320509 8014100508 Tecnis Mono 12mm Z9000+22,0 8094140509 8014110508  8094150509 8014120508 Tecnis Mono 12mm Z9000+22,5 8080300509 8014130508  8080310509 8014140508  8117480508 8014150508 Tecnis Mono 12mm Z9000+23,0 8012330508 8014160508  8012340508 8014190508  8012360508  Tecnis Mono 12mm Z9000+23,5 8160360508  8012370508  Tecnis Mono 12mm Z9000+24,0 8166940508  8012380508 8166960508  8012400508 8166970508  8012410508   8012430508   8012440508   8012450508   8012460508   8012470508   8012480508   8012510508   8012530508   8012540508   8013910508   8013920508   8013930508   8013940508   8013950508   8013960508   8013970508   8013980508   8013990508   8014000508   8014010508   8014020508   8014030508   8014040508  Tecnis Mono 12mm Z9000+24,5 8037770508  8037780508  8037790508  8037800508  8037810508  8037820508  8037830508  8037840508  8037850508  8037860508  8037870508  8037880508  8037890508  8037900508  8037910508  8037920508  8037930508  8037940508  8037950508  8037960508  8037970508  8037980508  8037990508  8163880508  8163890508  8163900508  8163910508  8163920508  8163930508  8163940508  8163950508  8163960508  8163970508  8163980508  8163990508  8164000508  8164010508  8164020508   Tecnis¿ Silicone Z9001, 13 lenses  Tecnis Mono 13mm Z9001+22.5 8030920508  8030930508  8031100508  8031110508  8031130508  8031140508  8031150508 Tecnis Mono 13mm Z9001+25,5 8111960508  8111970508  8111980508  8111990508  8112000508  8112020508

Ophthalmic Devices

3

Yes

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

Tecnis Monofocal Silicone Posterior Chamber IOLs (Models: Z9000 and Z9001)

Tecnis¿ Silicone ZM900, 7 lenses  Tecnis Multi 12mm ZM900+23,0 8027950508  8027960508  8027990508 Tecnis Multi 12mm ZM900+24,0 8026240508  8026260508  8026280508  8026310508

Ophthalmic Devices

3

Yes

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

Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900)

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)

Serial Numbers: 1114110408, 1119570408, 1142040205, 1143100207, 1147320306, 1147330306, 1157290307, 1159120306, 1200580409, 1200700409, 1215800307, 1245260307, 1251300402, 1269240205, 1312400308, 1320420307, 1322770202, 1339940208, 1346040309, 1376660402, 1403090305, 1519560303, 1519570303, 1537150408, 1544970308, 1545920407, 1552190306, 1644880406, 1649280409, 1701830307, 1718970304, 1736210308, 1771500312, 1793030407, 1794700312, 1812750311, 1850350301, 1852450310, 1868930404, 1869430308, 1891830306 & 1897480311.   All lenses are clearly identified with a 10 digit serial number. The format of the serial number is described below: Example of serial number format for lens: 1230010212  The first digit denotes the particular manufacturing plant within the AMO facility at Anasco, Puerto Rico, where the product was manufactured. The first digit codes are: - 1 or 2: Silicone Plant - 3: Silicone Rework Plant - 4 or 5: Acrylic Plant - 6: Acrylic Rework Plant Digits two through six denote the sequence of numbers assigned to the lenses. The seven and eighth digit denote the year of manufacture. The ninth and tenth digit denote the month of manufacture. In the serial number example above, the serial number represents the 23001 lens produced in the Silicone plant in December 2002.

Ophthalmic Devices

3

Yes

Nationwide

AMO PhacoFlex Il Model SI40NB Intraocular Lenses