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 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 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)

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 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)

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

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.

All lenses packaged weeks of 9-13 and 23-27 February.

Ophthalmic Devices

3

Yes

Nationwide.

STAAR Surgical Intra Occular Lens, Collamer.

Lot A004A02

Ophthalmic Devices

2

Yes

AZ, IL, NJ and Korea

MEDPOR¿ Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA

1) Products labeled with TEKIA as manufacturer: IOLs with power of 17.0 D (4 units): 616170E031002180207, 616170E031002190207, 616170E031002200207, 616170E031002210207; IOLs with power of 22.5 D (8 units): 616225E031001460207, 616225E031001470207, 616225E031001480207, 616225E031001490207, 616225E031001500207, 616225E031001510207; 616225E031001520207, 616225E031001530207.  2) Products labeled with Polytech as manufacturer: IOLs with power of 17.0 D (26 units): 613170E031000640207, 613170E031000650207, 613170E031000660207, 613170E031000670207, 613170E031000680207, 613170E031000690207, 613170E031000700207, 613170E031000710207,613170E031000720207, 613170E031000730207, 613170E031000740207, 613170E031000750207, 613170E031000760207, 613170E031000770207, 613170E031000780207, 613170E031000790207, 613170E031000800207, 613170E031000810207, 613170E031000820207, 613170E031000830207, 613170E031000840207, 613170E031000851207, 613170E031000860207, 613170E031000870207, 613170E031000880207, 613170E031000890207; IOLs with power of 22.5 D (22 units): 613225E031000990207, 613225E031001000207, 613225E031001010207, 613225E031001020207, 613225E031001030207, 613225E031001040207, 613225E031001050207, 613225E031001060207, 613225E031001070207, 613225E031001080207, 613225E031001090207, 613225E031001100207, 613225E031001110207, 613225E031001120207, 613225E031001130207, 613225E031001140207, 613225E031001150207, 613225E031001160207, 613225E031001170207, 613225E031001180207, 613225E031001190207, 613225E031001200207.

Ophthalmic Devices

3

Yes

Germany.

TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)

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

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

Lot number: M-50021 Product is not serialized.  Note: Lot code assigned by the contract manufacturing firm.

Ophthalmic Devices

2

Yes

Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.

Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 || The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. || The affected model which is the subject of this recall comes with the flat peg.

Ophthalmic Devices

Yes

Non-active implants - other implants

Lot Number: 110617

Ophthalmic Devices

3

Yes

Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

Intraocular Lens (IOL). || Model: EC-3, || Serial Number: 1169371106, 1169401106, 1169471106 || 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.

Lot Number: 110617

Ophthalmic Devices

3

Yes

Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

Precision Aspheric Lens (PAL) Intraocular Lens || Model: EC-3 PAL, || Serial Number: 1169381106, 1169391106, 1169421106 || 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.

Lot Number: 110617

Ophthalmic Devices

3

Yes

Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

UV-Absorbing Posterior Chamber IOL || Model: RS-55B, || Serial Number: || 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 1167231106, 1167241106, 1167251106, 1167261106, 1167271106, 1167281106, 1167291106, 1167301106, 1167311106, 1167321106, 1167331106, 1167341106, 1167351106, 1167361106, 1167371106, 1167381106, 1167391106, 1167401106, 1167411106, 1167421106, 1167431106, 1167441106, 1167451106, 1167461106, 1167471106, 1167481106, 1167491106, 1167501106, 1167511106, 1167521106, 1167531106, 1167541106, 1167551106, 1167561106, 1167571106, 1167581106, 1167591106, 1167601106, 1167611106, 1167621106, 1167631106, 1167641106, 1167651106, 1167661106, 1167671106, 1167681106, 1167691106, 1167701106, 1167711106, 1167721106, 1167731106, 1167741106, 1167751106, 1167761106, 1167771106, 1167781106, 1167791106, 1167801106, 1167811106, 1167821106, 1167831106, 1167841006, 1167851106, 1167861106, 1167871106, 1167881106, 1167891106, 1167901106, 1167911106, 1167921106, 1167931106, 1167941106, 1167951106, 1167961106, 1167971106, 1167981106, 1167991106, 1168001106, 1168011106, 1168021106, 1168031106, 1168041106, 1168051106, 1168061106, 1168071106, 1168081106, 1168091106, 1168101106, 1168111106, 1168121106, 1168131106, 1168141106, 1168151106, 1168161106, 1168171106, 1168181106, 1168191106, 1168201106, 1168211106, 1168221106, 1168231106, 1168241106, 1168251106, 1168261106, 1168271106, 1168281106, 1168291106, 1168301106, 1168311106, 1168321106, 1168331106, 1168341106, 1168351106, 1168361106, 1168371106, 1168381106, 1168391106, 1168401106, 1168411106, 1168421106, 1168431106, 1168441106, 1168451106, 1168461106. || 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.

Lot Number: 110617

Ophthalmic Devices

3

Yes

Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

UV-Absorbing Posterior Chamber IOL || Model: SP-65A2, || Serial Number: || 1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, 1168581106, 1168591106, 1168601106, 1168611106. || 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.

Item number 37-0000-08  Lot number of the recalled products: LOT121402

Ophthalmic Devices

3

Yes

Nationwide Distribution.

Product Name: nanoPOINT Injector System, item number 37-0000-08. || Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.

Model Numbers: SN6AD1, SN6AD3, SV25T0, MN6AD1,SND1T3, SND1T4, SND1T5 and SND1T6 and all lot numbers.

Ophthalmic Devices

3

Yes

Distribution Japan, No US distribution.

ReSTOR intraocular lens and ReSTOR Toric intraocular lens. || The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

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.

SN: U07310001 thru U07310040 , 07310050 thru U07310059

Ophthalmic Devices

3

Yes

Internationally to Vietnam.

TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Krupin Eye Valve, P/N 6003

Serial numbers: 10727A, 10733A, 10734A, 10735A, 10736A, 10737A, 10744A, 10745A, 10746A, 10747A, 10748A, 10749A, 10750A, 10751A, 10794A, 107795A, 10796A, 10797A, 10798A, 10799A, 10806A, 11056A through 11101A, and 11443A through 11456A.

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V

Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A, 11518A, 11550A, 11551A, 11554A, 11556A, and 11559A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V