Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776

Ophthalmic Devices

2

No

US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

LOT numbers:  072314-2328;  072314-2329;  072314-2330;  081314-2365;  081314-2366;  081314-2367;  091814-2345; 091814-2350;  100614-2344;   EXPIRATION DATES:  2018-05-15; 2018-07-23; 2018-08-13; 2018-08-14; 2018-09-14; 2018-09-14; 2018-09-25; 2018-10-06;

Ophthalmic Devices

Unclassified

No

Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and United Kingdom.

VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. || This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. || Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.

Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076

Ophthalmic Devices

2

No

Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.

MC-500 Multicolor Laser Photocoagulator; || Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.

Lot 1490288

Ophthalmic Devices

1

No

Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.

ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. || ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1)

Ophthalmic Devices

2

No

Nationwide Distribution.

FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). || Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) || 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); || 000000-2084-928 (USB drive with FORUM 3.2.1) || Ophthalmic image management system.

Serial numbers: 80007 80008 80009 80010 80011 80012 80013 80014 80015 80016 80017 80018 80019 80020 80021 80042 80043 80044 80045 80046 80047 80048 80049 80050 80051 80052 80053 80054 80055 80056 80077 80078 80079 80080 80081 80082 80083 80084 80085 80086 80087 80088 80089 80090 80091 80113 80114 80115 80116 80117 80118 80119 80120 80121 80122 80123 80124 80125 80129 80154 80155 80156 80157 80158 80159 80160 80161 80162 80163 80185 80186 80187 80188 80189 80190 80191 80192 80218 80219 80220 80221 80223 80224 80225 80255 80256 80257 80258 80259 80260 80261 80262 80263 80264 80290 80291 80292 80293 80294 80295 80296 80297 80327 80328 80329 80330 80331 80332 80333 80334 80335 80336 80337 80338 80339 80340 80341 80384 80385 80386 80387 80388 80389 80390 80391 80392 80393 80395 80417 80418 80419 80420 80421 80440 80441 80442 80443 80444 80445 80446 80501 80522 80523 80524 80525 80526 80527 80540 80541 80542 80543 80544 80545 80546 80547 80548 80549 80552 80553 80554 80555 80556 80573 80574 80575 80576 80577 80578 80579 80580 80581 80582 80583 80584 80585 80586 80587 80615 80616 80617 80618 80619 80620 80621 80622 80623 80624 80625 80626 80627 80628 80629 80649 80650 80651 80652 80653 80654 80655 80656 80657 80658 80659 80660 80661 80662 80663 80689 80690 80691 80692 80693 80694 80695 80696 80697 80698 80731 80732 80733 80734 80735 80736 80737 80738 80739 80740 80741 80770 80771 80772 80773 80774 80775 80776 80777 80778 80779 80780 80809 80810 80811 80812 80813 80814 80815 80816 80817 80818 80819 80820 80821 80822 80823 80846 80847 80848 80849 80850 80851 80852 80959 80960 80961 80962 80963 80996 80997 80998 81037 81038 81039 81040 81041 81042 81043 81044 81045 81046 81081 81082 81083 81084 81085 81086 81087 81088 81089 81090 81092 81093 81094 81095 81122 81123 81124 81125 81126 81127 81128 81129 81130 81131 81170 81171 81172 81173 81174 81175 81176 81177 81178 81179 81180 81181 81182 81183 81184 81226 81227 81228 81229 81230 81231 81232 81279 81280 81281 81338 81339 81340 81343 81344 81345 81372 81373 81374 81375 81376 81419 81420 81421 81422 81423 81424 81425 81426 81427 81428 81449 81450 81451 81452 81453 81454 81455 81456 81457 81458 81459 81460 81461 81462 81463 81485 81486 81487 81488 81489 81490 81491 81492 81493 81494 81495 81496 81497 81498 81499 81524 81525 81526 81527 81559 81560 81561 81562 81563 81564 81565 81566 81637 81638 81660 81661 81662 81663 81665 81666 81667 81668 81669 81680 81681 81682 81683 81684 81705 81706 81707 81708 81709 81710 81711 81732 81733 81755 81756 81777 81778 81779 81780 81781 81782 81783 81784 81785 81786 81806 81807 81808 81809 81810 81811 81812 81813 81814 81815 81816 81818 81819 81820 81821 81840 81841 81842 81843 81844 81845 81846 81847 81848 81849 81850 81851 81852 81853 81854 81874 81875 81876 81877 81878 81945 81947 81948 81971 81972 81973 82009 82010 82011 82012 82013 82014 82037 82039 82040 82041 82042 82060 82061 82062 82063 82064 82065 82066 82067 82068 82069 82070 82097 82098 82099 82100 82101 82102 82103 82104 82106 82107 82109 82111 82112 82113 82114 82127 82128 82129 82130 82131 82132 82133 82134 82138 82139 82140 82141 82142 82143 82144 82170 82171 82172 82173 82174 82175 82181 82182 82183 82184 82185 82186 82187 82188 82189 82205 82206 82207 82208 82213 82214 82215 82216 82217 82218 82233 82234 82235 82236 82245 82246 82247 82248 82249 82250 82268 82269 82270 82271 82272 82301 82302 82303 82304 82305 82306 82307 82325 82326 82327 82328 82329 82330 82331 82332 82353 82354 82355 82356 82357 82358 82359 82360 82384 82385 82386 82412 82413 82414 82440 82441 82442 82443 82444 82445 82446 82472 82473 82474 82475 82476 82477 82478 82479 82480 82481 82507 82508 82509 82510 82511 82512 82513 82514 82515 82516 82534 82536 82537 82538 82539 82540 82541 82559 82560 82561 82562 82563 82564 82585 82586 82587 82588 82589 82613 82614 82615 82616 82663 82664 82665 82666 82667 82707 82708 82709 82710 82711 82736 82737 82738 82739 82740 82741 82742 82743 82769 82770 82771 82772 82773 82774 82775 82776 82777 82778 82799 82800 82801 82802 82803 82804 82805 82806 82807 82808 82809 82810 82832 82833 82834 82835 82836 82837 82838 82839 82845 82846 82847 82848 82849 82854 82855 82856 82857 82858 82864 82865 82866 82867 82882 82883 82884 82886 82895 82896 82897 82898 82899 82900 82930 82931 82933 82934 82935 82987 82988 83011 83012 83034 83035 83036 83063 83064 83065 83087 83088 83089 83090 83091 83094 83095 83101 83103 83111 83112 83113 83114 83115 83116 83117 83118 83132 83133 83134 83135 83146 83147 83148 83149 83151 83167 83168 83169 83170 83171 83172 83181 83182 83183 83184 83186 83187 83188 83312 83313 83314 83315 83327 83328 83341 83342 83346 83347 83348 83349 83350 83351 83352 83353 83354 83373 83374 83375 83376 83377 83398 83400 83401 83402 83431 83433 83435 83439 83501 83502 83503 83505 80222 80394 81091 82558 82863 82885 83102 83150 83185 83432 83434 83436 83437 83438 83505 83506 83507 83508 83509 83510 83511 83512 83513 83514 83515 83516 83517 83518 83519 83520 83521 83522 83523 83528 83529 83530 83531 83536 83537 83538 83539 83540 83541 83542 83543 83544 83548 83549 83550 83551 83552 83553 83554 83555 83592 83593 83594.

Ophthalmic Devices

2

No

Nationwide Distribution.

YC-1800 OPHTHALMIC YAG LASER SYSTEM; || The YC-1800 allows the safe and bloodless treatment of intraocular || diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.

Lot 40905AQ and 40601C

Ophthalmic Devices

1

No

Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.

LIS27T - Lacrimal Intubation Set RX Only Sterile || Used in various ophthalmology procedures.

Software version 3.00.05: Serial numbers - US:  44066413 44063113 44065413 44066213 44102714 44060012 44064813 44061012 44061812 44101614 44068314 44056612 44063713 44102614 44068914 44073514 44074814 44061612 44073714 44056312 44061412 44066613 44069414 44069814 44070914 44072714 44073014 44073114 44074514 44074614 44100714 44068014 44060612 44062813 44066914 44056012 44062213 44064513 44101014 44100814 44060312 44060412 44063513 44056712 44063313 44063913 44073314 44065613 44058312 44065013 44072114 44072414 44071914 44062613 44065213 44059912 44057312 44059712 44058212 44072814 44060712 44060112 44057812 44058012 44059612 44069114  Serial numbers - OUS:  44055211 44055411 44055711 44056112 44056212 44056412 44056512 44056912 44057112 44057212 44057412 44057512 44057712 44057912 44058512 44058612 44058912 44059012 44059112 44059412 44059512 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44063213 44064013 44064213 44065513 44066313 44066813 44067214 44067414 44067514 44067714 44068114 44068414 44068614 44069214 44069514 44069914 44070014 44070114 44070614 44070714 44071014 44071214 44071314 44071414 44071514 44071714 44071814 44072214 44072314 44072614 44073414 44074014 44074214 44074414 44074714 44074914 44100114 44100614 44101714 44101814 44101914 44102014.

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada.

Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 || The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

Product #s: 157400; 257400; 157500; 257500

Ophthalmic Devices

1

No

Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.

Steriseal-Cannula Ophthalmic; || Bi-Manual Irrigating/Aspirating Handpiece.

Device Serial No. (U.S.) 44055311 44055611 44055811 44056012 44056312 44056612 44056712 44056812 44057312 44057812 44058012 44058212 44058312 44059212 44059312 44059612 44059712 44059812 44059912 44060012 44060112 44060312 44060412 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062413 44062613 44062813 44063113 44063313 44063413 44063513 44063613 44063713 44063813 44063913 44064113 44064313 44064413 44064513 44064613 44064713 44064813 44065013 44065113 44065213 44065313 44065413 44065613 44066213 44066413 44066613 44066914 44067014 44068014 44068314 44068914 44069114 44069414 44069814 44070414 44070914 44071914 44072114 44072414 44072714 44072814 44072914 44073014 44073114 44073214 44073314 44073514 44073714 44074114 44074514 44074614 44074814 44100714 44100814 44101014 44101114 44101414 44101614 44102514 44102614 44102714  Device Serial No. (Outside U.S.) 44055211 44055411 44055711 44055911 44056112 44056212 44056412 44056512 44056912 44057112 44057212 44057412 44057512 44057612 44057712 44057912 44058112 44058512 44058612 44058912 44059012 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062913 44063013 44063213 44064013 44064213 44065513 44065713 44065813 44065913 44066313 44066513 44066713 44066813 44067114 44067214 44067414 44067514 44067614 44067714 44067914 44068114 44068214 44068414 44068514 44068614 44069014 44069214 44069314 44069514 44069914 44070014 44070114 44070214 44070314 44070514 44070614 44070714 44070814 44071014 44071114 44071214 44071314 44071414 44071514 44071614 44071714 44071814 44072014 44072214 44072314 44072514 44072614 44073414 44073614 44073814 44073914 44074014 44074214 44074314 44074414 44074714 44074914 44100114 44100214 44100614 44100914 44101314 44101514 44101714 44101814 44101914 44102014 44102114 44064913R

Ophthalmic Devices

2

No

Worldwide Distribution - US Nationwide and the countries of, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand, Colombia, Ecuador, Italy, Brazil, Egypt, Tunsia, Belgium, Mexico, Greece, Guatemala, Chile, Turkey, Peru, Hong Kong, Saudi Arabia, Bangladesh, and Dominican Rep.

OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). || Product Usage: || Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

Model #V25LC, Lot: BE09243

Ophthalmic Devices

2

No

Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Model: L90C, Lot: BE03356.

Ophthalmic Devices

1

No

Distribution to VA only

Lombart 90D Clear with case || Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

Alll devices currently in use by consignees.

Ophthalmic Devices

3

No

Us distribution only.

EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. || Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.

Accurus 23 GA Standalone Vitreous Probe: Lot Number: 14010428X, Expiration Date: 1/14/2017; Lot Number: 14012987X, Expiration Date: 2/17/2017; Lot Number: 14014736X, Expiration Date: 3/11/2017; Lot Number: 14016577X, Expiration Date: 3/26/2017; Lot Number: 14017912X, Expiration Date: 4/27/2017; Lot Number: 14020280X, Expiration Date: 5/21/2017; Lot Number: 14022920X, Expiration Date: 6/19/2017; Lot Number: 14024168X, Expiration Date: 6/22/2017; Lot Number: 14026031X, Expiration Date: 7/27/2017; Lot Number: 14028553X, Expiration Date: 8/12/2017; Lot Number: 14029477X, Expiration Date: 8/26/2017; Lot Number: 14033830X, Expiration Date: 10/14/2017; Lot Number: 14036315X, Expiration Date: 11/17/2017;  Accurus 25+ 2500 CPM Stand-Alone Vitreous Probe: Lot Number: 14010429X, Expiration Date: 1/14/2014; Lot Number: 14012985X, Expiration Date: 2/17/2017; Lot Number: 14014737X Expiration Date: 3/11/2017; Lot Number: 14016477X Expiration Date: 3/26/2017; Lot Number: 14018320X Expiration Date: 4/27/2017; Lot Number: 14020282X Expiration Date: 5/21/2017; Lot Number: 14022922X Expiration Date: 6/19/2017; Lot Number: 14026032X Expiration Date: 7/27/2017; Lot Number: 14028554X Expiration Date: 8/12/2017; Lot Number: 14033831X Expiration Date: 10/15/2017; Lot Number: 14036315X Expiration Date: 11/16/2017;   Anterior Accurus Probe with Infusion Needle: Lot Number: 14010430X Expiration Date: 1/14/2017; Lot Number: 14012984X Expiration Date: 2/17/2017; Lot Number: 14014739X Expiration Date: 3/11/2017; Lot Number: 14017451X Expiration Date: 4/15/2017; Lot Number: 14020283X Expiration Date: 5/21/2017; Lot Number: 14022923X Expiration Date: 6/19/2017; Lot Number: 14024219X Expiration Date: 6/22/2017; Lot Number: 14026034X Expiration Date: 7/27/2017; Lot Number: 14028555X Expiration Date: 8/12/2017; Lot Number: 14031264X Expiration Date: 9/22/2017; Lot Number: 14033832X Expiration Date: 10/15/2017;  Accurus 2500 Stand-Alone Vitreous Probe: Lot Number: 14014738X Expiration Date: 3/11/2017; Lot Number: 14017452X Expiration Date: 4/15/2017; Lot Number: 14020246X Expiration Date: 5/21/2017; Lot Number: 14022921X Expiration Date: 6/19/2017; Lot Number: 14026030X Expiration Date: 7/27/2017; Lot Number: 14028440X Expiration Date: 8/6/2017; Lot Number: 14031263X Expiration Date: 9/22/2017; Lot Number: 14033833X Expiration Date: 10/15/2017; Lot Number: 14036297X Expiration Date: 11/16/2017

Ophthalmic Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, International APL, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. || Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.

Ophthalmic Devices

1

No

Nationwide Distribution.

OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic || Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. || Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.

Code:9001611 Lots: 141015771 exp. 8/30/18 141216412 exp. 12/31/15 150116994 exp. 2/28/16 150418309 exp. 4/30/16 150619176 exp. 6/30/16

Ophthalmic Devices

2

No

Distributed Only in Puerto Rico.

RETINA PACK 7/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9001780 Lots: 141015756 exp. 9/30/16 141216419 exp. 12/31/16 150116978 exp. 2/28/16 150317700 exp. 4/30/16 150317701 exp. 4/30/16 150317702 exp. 4/30/16 150518592 exp. 6/30/16 150518593 exp. 6/30/16 150518594 exp. 6/30/16 150518594 exp. 6/30/16

Ophthalmic Devices

2

No

Distributed Only in Puerto Rico.

OPHTHALMIC PACK 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9001933 Lots: 140814975 exp. 6/30/17 140513118 exp. 6/30/17 141216436 exp. 12/31/15 150116975 exp. 1/31/16 150116781 exp. 2/28/16 150518667 exp. 5/31/16 150619226 exp. 6/30/16

Ophthalmic Devices

2

No

Distributed Only in Puerto Rico.

OPHTHALMIC PACK 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16

Ophthalmic Devices

2

No

Distributed Only in Puerto Rico.

CATARACT PACK 6/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

LOTS: SL15169 (150518594) 30-JUN-16 SL15170 (150518592) 30-JUN-16 SL15199 (150719720) 30-JUN-16 SL15199 (150719719) 30-JUN-16 SL15203 (150719720) 30-JUN-16 SL15230 (150819721) 30-JUN-16 SL15231 (150819722) 30-JUN-16 SL15231 (150820230) 30-JUN-16 SL15243 (150820231) 30-JUN-16 SL15243 (150820229) 30-JUN-16 SL15259 (150920791) 30-JUN-16 SL15259 (150920917) 30-JUN-16

Ophthalmic Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 9001780 || OPHTHALMIC SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15176 (150619390) 30-JUN-16 SL15231 (150819833) 31-AUG-16 SL15233 (150619391) 31-AUG-16 SL15240 (150819834) 31-AUG-16 SL15259 (150920237) 30-SEP-16 SL15259 (150920236) 30-SEP-16

Ophthalmic Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 9001933 || OPHTALMIC SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

LOTS: SL15180 (150619377) 30-JUN-16 SL15184 (150619377) 30-JUN-16 SL15229 (150619378) 31-AUG-16 SL15230 (150819814) 31-AUG-16 SL15231 (150820356) 31-AUG-16 SL15231 (150819816) 31-AUG-16 SL15231 (150819815) 31-AUG-16 SL15259 (150920355) 30-SEP-16 SL15261 (150920357) 30-SEP-16 SL15266 (150920358) 30-SEP-16

Ophthalmic Devices

2

No

Distributed only in Puerto Rico.

Catalog Number: 900944 || CATARACT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Model #: VG4SNF, Lot: BE05200

Ophthalmic Devices

2

No

Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.

Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 || for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.

Ophthalmic Devices

1

No

US Nationwide Distribution

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

Serial Numbers: 1017, 1119, 1123, 1125, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1139, 1142, 1147, 1150, 1153, 1155, 1161, 1165, 1168, 1172, 1178, 1181, 1182, 1183, 1188, 1190, 1191, 1193, 1196, 1197, 1198, 1199, 1201, 1203, 1206, 1207, 1220, 1226, 1228, 1230, 1232, 1250, 1256, 1258, 1259, 1421, 1433, 1435, 1439, 1451, 1452, 1506, 1508, 1509, 1523, 1536, 1548, 1559, 1562, 1565, 1568, 1581, 1597, 1606, 1628, 1632, 1649, 1661, 1663, 1668, 1671, 1694, 1696, 1705, 1716, 1726, 1729, 1798, 1816, 1818, 1820, 1824, 1829, 1921, 1922, 1934, 1937, 1938, 1940, 1942, 1954, 1957, 2057, 2069, 2086, 2092

Ophthalmic Devices

1

No

Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hungary, India, Indoesia, Isreal, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Panama, Philippines, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UK, Ukrain, United Arab Emirates

VERION Reference Unit (Vision Planner) || Product Usage: || The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.