Serial Numbers:  FLM4455 FLM2313 FLM4499 FLM3230 FLM2855 FLM3097 FLM4493 FLM3178 FLM4441 FLM1592 FLM2595 FLM1225 FLM4542 FLM3771 FLM1464 FLM3999 FLM2408 FLM1995 FLM4409 FLM2185 FLM2679 FLM4987 FLM3815 FLM3904 FLM1958 FLM1179 FLM2869 FLM2584 FLM4860 FLM3766 FLM2318 FLM3406 FLM4626 FLM2324 FLM1326 FLM2053 FLM2096 FLM4222 FLM4450 FLM2266 FLM4588 FLM4175 FLM4764 FLM4902 FLM4227 FLM2457 FLM1767 FLM4132 FLM4896 FLM3007 FLM1274 FLM1009 FLM1320 FLM2537 FLM3278 FLM2508 FLM3905 FLM4043 FLM4133 FLM4314 FLM1819 FLM2186 FLM3135 FLM2627 FLM4271 FLM1092 FLM4759 FLM1724 FLM2589 FLM4770 FLM2038 FLM1188 FLM1640 FLM1915 FLM4317 FLM1814 FLM2812 FLM1003 FLM4859 FLM1135 FLM4807 FLM1502 FLM3183 FLM1182 FLM4954 FLM4000 FLM4531 FLM2551 FLM1554 FLM3539 FLM1046 FLM2765 FLM4897 FLM2913 FLM1093 FLM4632 FLM1686 FLM2912 FLM1782 FLM1545 FLM3359 FLM4908 FLM2085 FLM1407 FLM1863 FLM4308 FLM3677 FLM2636 FLM1008 FLM4361 FLM4669 FLM4498 FLM3729 FLM1773 FLM1364 FLM1591 FLM1824 FLM2229 FLM2450 FLM2722 FLM3676 FLM3861 FLM4593 FLM3040 FLM2001

Ophthalmic Devices

2

No

Worldwide Distribution: US (nationwide) including states of: AL, CA, FL, GA, IL, IN, MN, OR, TN, TX, VA, and WA; and countries of: Argentina, Austria, Belgium, Brazil, Canada, France, Germany, India, Iraq, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Namibia, Pakistan, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, South Africa, Switzerland, Taiwan, and United Arab Emirates.

The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser || The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

Lot Numbers: AH01257.

Ophthalmic Devices

2

No

International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.

AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). || Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

All Serial Numbers on the market

Ophthalmic Devices

2

No

Worldwide: USA, Canada and India

Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.

122590, 123372, 123215, 122309.

Ophthalmic Devices

2

No

Nationwide Distribution.

- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 || - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 || - TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 || Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 || Phacofragmentation system.

Lot numbers: M264400, M265330, and M270010

Ophthalmic Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

Lot number: GH0078

Ophthalmic Devices

2

No

Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil

Up&Up; Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403 || Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

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.

All lots manufactured September 01, 2011 to September 19, 2013.

Ophthalmic Devices

3

No

Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.

Viscocel and Viscocel Plus. || These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

2010-10-14, 2010-12-02, 2012-02-03, 2012-03-17, 2012-04-14, 2012-06-23, 2012-07-20, 2012-10-12, 2012-11-30, 2013-03-12, 2013-04-08, 2013-04-22, 2013-07-28, 2013-09-01.

Ophthalmic Devices

1

No

Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.

Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.

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.

Lot Number: 6181868

Ophthalmic Devices

1

No

Nationwide.

BD Visitec Irrigating Cytosome, for use in cataract surgery. || Ref 581618

Lot number: 3079324

Ophthalmic Devices

1

No

Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.

Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) || REF 585006 || Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth

P/N 1462-333, Size M, Lot # M130010

Ophthalmic Devices

2

No

US Distribution: NV only.

Treatment packs used on the VisuMax Laser Keratome. || Size M || Manufactured by Carl Zeiss Meditec AG, || Jena, Germany. || The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

Lot number: M274760

Ophthalmic Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

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 #: 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

2013-01-12, 2013-09-13.

Ophthalmic Devices

1

No

Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.

Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.

System Serial Numbers affected include: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041

Ophthalmic Devices

3

No

Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.

Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.

Lot number: M264060

Ophthalmic Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.

Ophthalmic Devices

2

No

Nationally

Widefield OCT software feature for the Spectralis HRA+OCT and variants

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.

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.

All lots

Ophthalmic Devices

1

No

Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.

Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. || The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

All lots

Ophthalmic Devices

1

No

Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.

Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. || The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

Ophthalmic Devices