Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z LWN1513Z LWN1522Z LWN1626Z LWN1629Z LWN1647Z LWN1748Z LWN1796Z LWN1805Z LWN1817Z LWN1820Z LWN1821Z LWN1822Z LWN1823Z LWN1843Z LWN1846Z LWN1944Z LWN1945Z LWN1946Z LWN1947Z LWN1949Z LWN1950Z LWN1952Z LWN1953Z LWN1954Z LWN1955Z LWN1956Z LWN1957Z LWN1958Z LWN1959Z LWN1961Z LWN2187Z LWN2188Z LWN2189Z LWN2190Z LWN2191Z LWN2192Z LWN2193Z LWN2194Z LWN2197Z LWN2198Z LWN2199Z LWN2200Z LWN2262Z LWN2263Z LWN2264Z LWN2265Z LWN2267Z LWN2268Z LWN2269Z LWN2270Z LWN2271Z LWN2272Z LWN2273Z LWN2276Z LWN2277Z LWN2278Z LWN2279Z LWN2280Z LWN2342Z LWN2343Z LWN2344Z LWN2345Z LWN2346Z LWN2347Z LWN2348Z LWN2349Z LWN2350Z LWN2351Z LWN2352Z LWN2353Z LWN2355Z LWN2356Z LWN2357Z LWN2403S LWN2404S LWN2405S LWN2406S LWN2414Z LWN2415Z LWN2416Z LWN2417Z LWN2420Z LWN2421Z LWN2427S LWN2428S LWN2464Z LWN2465Z LWN2466Z LWN2467Z LWN2468Z LWN2469Z LWN2470Z LWN2471Z LWN2472Z LWN2473Z LWN2475Z LWN2476Z LWN2477Z LWN2478Z LWN1609Z LWN1951Z

Ophthalmic Devices

109 U.S. customers and 48 international device locations. There were 12 devices on-hand.

Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91

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.

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.

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.

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.

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.

1281706, 1282812

Ophthalmic Devices

1

No

US

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

none

Ophthalmic Devices

1

No

US Nationwide Distribution

LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only || Product Usage: || The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Serial numbers: C5013,C5014,C5015,C5016,C5017,C5018,C5019,C5020,C5021,C5023,C5024,C5025,C5026,C5027,C5028,C5029,C5030,C5031,C5032,C5033,C5034,C5035,C5036,C5038,C5039,C5040,C5041,C5042,C5043,C5044, C5045,C5046,C5047,C5048,C5049,C5050,C5051,C5053,C5054,C5055,C5059,C5060,C5061,C5062,C5064, C5065,C5066,C5069,C5071,C5075,C5076,C5077,C5078,C5079,C5080,C5081,C5082,C5083,C5090,C5093, C5094,C5097,C5098,C5101,C5102,C5105,C5106,C5107,C5108,C5109,C5110,C5111,C5112,C5113,C5116, C5117,C5119,C5120,C5121,C5122,C5125,C5126,C5127,C5128,C5129,C5130,C5131,C5132,C5133,C5134, C5136,C5137,C5138,C5139,C5140,C5141,C5142,C5143,C5144,C5146,C5147,C5148,C5149,C5150,C5151, C5152,C5153,C5154,C5155,C5156,C5157,C5158,C5159,C5160,C5161,C5163,C5164,C5165,C5166,C5167, C5168,C5169,C5170,C5171,C5173,C5174,C5175,C5176,C5177,C5178,C5179,C5180,C5181,C5182,C5183, C5184,C5185,C5186,C5187,C5188,C5189,C5190,C5191,C5192,C5193,C5194,C5195,C5196,C5197,C5198, C5199,C5200,C5201,C5202,C5203,C5204,C5205,C5207,C5214,C5215,C5216,C5217,C5218,C5219,C5220, C5221,C5222,C5223,C5224,C5225,C5226,C5227,C5228,C5229,C5230,C5231,C5232,C5233,C5238,C5239, C5240,C5241,C5242,C5243,C5244,C5245,C5246,C5248,C5249,C5250,C5251,C5252,C5253,C5255,C5256, C5257,C5258,C5259,C5260,C5261,C5262,C5263,C5264,C5265,C5266,C5267,C5268,C5269,C5270,C5271, C5272,C5273,C5274,C5276,C5277,C5278,C5279,C5280,C5281,C5282,C5283,C5284,C5285,C5286,C5287, C5288,C5289,C5290,C5291,C5292,C5293,C5294,C5295,C5296,C5297,C5298,C5299,C5300,C5301,C5302, C5303,C5304,C5305,C5306,C5307,C5308,C5309,C5310,C5311,C5312,C5313,C5314,C5315,C5316,C5317, C5318,C5319,C5320,C5321,C5322,C5323,C5326,C5328,C5329,C5330,C5334,C5335,C5336,C5339,C5340, C5341,C5343,C5348,C5349,C5350,C5352,C5353,C5354,C5355,C5356,C5357,C5358,C5359,C5360,C5361, C5362,C5363,C5364,C5365,C5366,C5368,C5369,C5370,C5371,C5372,C5373,C5374,C5375,C5376,C5377, C5378,C5379,C5380,C5381,C5382,C5383,C5384,C5385,C5386,C5387,C5388,C5389,C5390,C5391,C5392, C5393,C5394,C5395,C5396,C5397,C5398,C5399,C5400,C5401,C5402,C5403,C5404,C5405,C5406,C5407, C5408,C5409,C5410,C5411,C5412,C5413,C5414,C5415,C5416,C5417,C5418,C5434,C5435,C5436,C5437, C5438,C5439,C5440,C5441,C5442,C5443,C5444,C5446,C5448,C5449,C5451,C5452,C5453,C5454,C5456, C5458,C5462,C5463,C5464,C5465,C5466,C5467,C5469,C5471,C5473,C5475,C5476,C5477,C5478,C5479, C5484,C5485,C5486,C5487,C5488,C5489,C5490,C5493,C5494,C5495,C5496,C5497,C5499,C5500,C5501, C5502,C5503,C5507,C5508,C5509,C5510,C5511,C5512,C5515,C5516,C5517,C5518,C5519,C5520,C5521, C5522,C5524,C5525,C5526,C5527,C5528,C5529,C5530,C5532,C5533,C5534,C5535,C5536,C5537,C5538, C5539,C5544,C5545,C5546,C5547,C5549,C5550,C5553,C5555

Ophthalmic Devices

1

No

Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom

ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

Serial Numbers: C0002,C2006,C2020,C2026,C2054,C3009R,C3010R,C3024,C3036,C3066,C3067,C3085R,C3090,C3093,C3108,C3136,C3153,C4001,C4003,C4005,C4006,C4007,C4009,C4010,C4011,C4012,C4013,C4014,C4015,C4016,C4017,C4019,C4020,C4021,C4022,C4023,C4024,C4025,C4026,C4027,C4028,C4029,C4030,C4031,C4035,C4036,C4037,C4038,C4039,C4040,C4043,C4045,C4046R,C4047R,C4049R,C4050R,C4052R,C4053R,C4054R,C4055R,C4056R,C4057R,C4058R,C4059R,C4060R,C4061R,C4062R,C4065R,C4066R,C4067R,C4068R,C4069R,C4070R,C4071R,C4072R,C4073R,C4074R,C4075R,C4076R,C4077R,C4078R,C4079R,C4080R,C4083R,C4085R,C4086R,C4087RC4088R,C4089R,C4090R,C4091R,C4092R,C4093R,C4094R,C4095R,C4096R,C4097R,C4098R,C4099R,C4100R,C4101R,C4102R,C4103R,C4104R,C4105R,C4106R,C4107R,C4108R,C4109R,C4110R,C4111R,C4112R,C4113R,C4115R,C4117R,C4118R,C4119R,C4120R,C4121R,C4122R,C4123R,C4124R,C4126R,C4127R,C4128R,C4129R,C4130R,C4132R,C4133R,C4134R,C4135R,C4136R,C4138R,C4140,C4142,C4143,C4144,C4145,C4146,C4147,C4148,C4149,C4150,C4151,C4152R,C4153,C4154,C4155,C4156,C4157R,C4158,C4159,C4160R,C4161R,C4162R,C4163R,C4164R,C4165R,C4166R,C4167R,C4168R,C4169R,C4170R,C4173R,C4174R,C4175,C4177R,C4178R,C4179R,C4180R,C4181R,C4182R,C4183R,C4184R,C4185R,C4186R,C4187R,C4188R,C4189R,C4190R,C4191R,C4192R,C4193R,C4195R,C4196R,C4197R,C4198,C4199R,C4200R,C4201,C4202R,C4203R,C4204R,C4205R,C4206R,C4207R,C4208R,C4209R,C4210R,C4211R,C4212R,C4213R,C4214R,C4215R,C4216R,C4217R,C4218R,C4219R,C4220R,C4221R,C4222R,C4223R,C4224R,C4225R,C4226R,C4227R,C4228R,C4229R,C4230R,C4231R,C4232R,C4233R,C4234R,C4235R,C4238R,C4239R,C4240R,C4241R,C4242R,C4243R,C4244R,C4245R,C4246R,C4247R,C4248R,C4249R,C4251R,C4252R,C4253R,C4254R,C4255R,C4256R,C4257R,C4258R,C4259R,C4260R,C4261R,C4262R,C4264R,C4266R,C4267R,C4268R,C4269R,C4271R,C4272R,C4273R,C4274R,C4275R,C4276R,C4278R,C4279R,C4280R,C4283R,C4284R,C4285R,C4286R,C4287R,C4288R,C4289R,C4290R,C4291R,C4292R,C4293R,C4294R,C4295R,C4296R,C4297R,C4298R,C4299R,C4300R,C4301R,C4302R,C4303R,C4304R,C4305R,C4306R,C4307R,C4308R,C4309R,C4310R,C4311R,C4312R,C4315R,C4316R,C4317R,C4318R,C4319R,C4320R,C4321R,C4323R,C4324R,C4326R,C4327R,C4328R,C4331R,C4332R,C4334R,C4337R,C4339R,C4340R,C4341R,C4342R,C4343R,C4344R,C4345R,C4346R,C4347R,C4348R,C4349R,C4352R,C4354R,C4355R,C4356R,C4357R,C4358R,C4359R,C4360R,C4361R,C4363R,C4364R,C4365R,C4366R,C4367R,C4368R,C4371R,C4372R,C4373R,C4374R,C4376R,C4377R,C4378R,C4379R,C4380R,C4381R,C4382R,C4383R,C4384R,C4385R,C4387R,C4388R,C4389R,C4394,C4396,C4397,C4399,C4406R,C4407R,C4408R,C4415,C4418,C4420,C4421,C4422,C4423,C4424,C4425,C4426

Ophthalmic Devices

1

No

Worldwide distribution. US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom

ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.

Ophthalmic Devices

1

No

Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.

AUTO REF/KERATOMETER ARK-1s

Model Number: 525004, 05 and 525006, 07

Ophthalmic Devices

1

No

Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.

Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) || The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.

All codes are affected by Safety Alert: 98-3002-005; 98-3002-01-017; 98-3002-02-001; 98-3002-02-002; 98-3002-02-007-03; 98-3002-03-001; 98-3002-03-003; 98-3002-03-004; 98-3002-03-006; 98-3002-03-007; 98-3002-03-010; 98-3002-03-013; 98-3002-03 018; 092K14; 98-3002-04-001; 98-3002-04-002; 98-3002-04-003; 98-3002-04-004; 98 3002-04-005; 98-3002-04-006; 98-3002-04-007; 98-3002-04-008; 98-3002-04-009; 98-3002-04-010; 98-3002-04-011; 98-3002-04-012; 98-3002-04-013; 98-3002-04-014; 98-3002-04-015; 98-3002-04-016; 98-3002-04-017; 98-3002-04-018; 98-3002-04-019; 98-3002-04-020; 98-3002-04-021; 98-3002-04-022; 98-3002-04-023; 98-3002-04-024; 98-3002-04-025; 98-3002-04-026; 98-3002-04-027; 98-3002-04-028; 98-3002-04-029; 98-3002-04-030; 99-0204-001-IR; 99-0204-002-IR; 99-0304-003-IR; 99-0304-004-IR; 99-0304-005-IR; 99-0304-006-IR; 99-0304-007-IR; 99-0304-008-IR; 99-0304-009-IR; 99-0304-010-IR; 99-0504-011 -IR; 99-0404-001-GE; 99-0404-002-GE; 99-0404-003-GE; 99-0404-004-GE; 99-0404-005-GE; 99-0404-006-GE; 99-0404-007-GE; 99-0404-011-IR; 99-0404-012-IR; 99-0404-013-IR; 99-0404-014-IR; 99-0404-015-IR; 99-0404-016-IR; 99-0404-017-IR; 99-0404-018-IR; 99-0504-001-GE; 99-0504-002-GE; 99-0504-003-GE; 99-0504-004-GE; 99-0504-005-GE; 99-0504-006-GE; 99-0504-007 GE; 99-0504-008-GE; 99-0504-009- GE; 99-0504-010-GE; 99-0504-019-IR; 99-0504-020-IR; 99-3002-04-001; 99-3002-04-002; 99-3002-04-003; 99-3002-04-004; 99-3002-04-005; 99-3002-04-006; 99-3002-04-007; 99-3002-04-008; 99-3002-04-009; 99-3002-04-010; 99-3002-04-011; 99-3002-04-012; 99-3002-04-013; 99-3002-04-014; MK31001; MK31002; MK31003; MK31004; MK31005; MK31006; MK31007; MK31008; MK31009; MK31010; MK31011; MK31012; MK31013; MK31014; MK31015; MK31016; MK31017; MK31018; MK31019; MK31020; MK31021; MK31022; MK31023; MK31024; MK31025; MK31026; MK31027; MK31028; MK31029; MK31030; MK31031; MK31032; MK31033; MK31034; MK31035; MK31036; MK31037; MK31038; MK31039; MK31040; MK31041; MK31042; MK31043; MK31044; MK31045; MK31046; MK31047; MK31048; MK31049; MK31050; MK31051; MK31052; MK31053; MK31054; MK31055; MK31056; MK31057; MK31058; MK31059; MK31060; MK31061; MK31062; MK31063; MK31064; MK31065; MK31066; MK31067; MK31068; MK31069; MK31070; MK31071; MK31072; MK31073; MK31074; MK31075; MK31076; MK31077; MK31078; MK6021/G; MK6022/G; MK6023/G; MK6024/G; MK6025/G; MK6026/G; MK6027/G; MK6028/G; MK6029/G; MK6030/G; MK6031/G; MK6032/G; MK6033/G; MK6034/G; MK6035/G; MK6036/G; MK6037/G; MK6038; MK6039; MK6040; MK6041/J; MK6042; MK6043/G; MK6044; MK6045; MK6046; MK6047; MK6048; MK6060E; MK7000; MK7001; MK7002; MK7003; MK7004; MK7005; MK7006; MK7007; MK7008; MK7009; MK7010; MK7011; MK7012; MK7013; MK7014; MK7015; MK7016; MK7017; MK7018; MK7019; MK7020; MK7021; MK7022; MK7023; MK7024; MK7025; MK7026; MK7027; MK7028; MK7029; MK7030; MK7031; MK7032; MK7033; MK7034; MK7035; MK7036; MK7037; MK7038; MK7039; MK7040; MK7041; MK7042; MK7043; MK7044; MK7045; MK7046; MK7047; MK7048; MK7049; MK7050; MK7051; MK7052; MK7053; MK7054; MK7055; MK7056; MK7057; MK7058; MK7059; MK7060; MK7061; MK7062; MK7063; MK7064; MK7065; MK7066; MK7067; MK7068; MK7069; MK7070; MK7071; MK7072; MK7073; MK7074; MK7075; MK7076; MK7077; MK7078; MK7079; MK7080; MK7081; MK7082; MK7083; MK7084; MK7085; MK7086; MK7087; MK7088; MK7089; MK7090; MK7091; MK7092; MK7093; MK7094; MK7095; MK7096; MK7097; MK7098; MK7099; MK7100; MK7101; MK7102; MK7103; MK7104; MK7105; MK7106; MK7107; MK7108; MK7109; MK7110; MK7111; MK7112; MK7113; MK7114; MK7115; MK7116; MK7117; MK7118; MK7119; MK7120; MK7121; MK7122; MK7123; MK7124; MK7125; MK7126; MK7127; MK7128; MK7129; MK7130; MK7131; MK7132; MK7133; MK7134; MK7135; MK7136; MK7137; MK7138; MK7139; MK7140; MK7141; MK7142; MK7143; MK7144; MK7145; MK7146; MK7147; MK7148; MK7149; MK7150; MK7151; MK7152; MK7153; MK7154; MK7155; MK7156; MK7157; MK7158; MK7159; MK7160; MK7161; MK7162; MK7163; MK7164; MK7165; MK7166; MK7167; MK7168; MK7169; MK7170; MK7171; MK7172; MK7173; MK7174; MK7175; MK7176; MK7177; MK7178; MK7179; MK7180; MK7181; MK7182; MK7183; MK7184; MK7185; MK7186; MK7187; MK7188; MK7189; MK7190; MK7191; MK7192; MK7193; MK7194; MK7195; MK7196; MK7197; MK7198; MK7199; MK7200; MK7201; MK7202; MK7203; MK7204; MK7205; MK7206; MK7207; MK7208; MK7209; MK7210; MK7211; MK7212; MK7213; MK7214; MK7215; MK7216; MK7217; MK7218; MK7219; MK7220; MK7221; MK7222; MK7223; MK7224; MK7225; MK7226; MK7227; MK7228; MK7229; MK7230; MK7231; MK7232; MK7233; MK7234; MK7235; MK7236; MK7237; MK7238; MK7239; MK7240; MK7241; MK7242; MK7243; MK7244; MK7245; MK7246; MK7247; MK7248; MK7249; MK7250; MK7251; MK7252; MK7253; MK7254; MK7255; MK7256; MK7257; MK7258; MK7259; MK7260; MK7261; MK7262; MK7263; MK7264; MK7265; MK7266; MK7267; MK7268; MK7269; MK7270; MK7271; MK7272; MK7273; MK7274; MK7275; MK7276; MK7277; MK7278; MK7279; MK7280; MK7281; MK7282; MK7283; MK7284; MK7285; MK7286; MK7287; MK7288; MK7289; MK7290; MK7291; MK7292; MK7293; MK7294; MK7295; MK7296; MK7297; MK7298; MK7299; MK7300; MK7301; MK7302; MK7303; MK7304 MK7305; MK7306; MK7307; MK7308; MK7309; MK7310; MK7311; MK7312; MK7313; MK7314; MK7315; MK7316; MK7317; MK7318; MK7319; MK7320; MK7321; MK7322; MK7323; MK7324; MK7325; MK7326; MK7327; MK7328; MK7329; MK7330; MK7331; MK7332; MK7333; MK7334; MK7335; MK7336; MK7337; MK7338; MK7339; MK7340; MK7341; MK7342; MK7343; MK7344; MK7345; MK7346; MK7347; MK7348; MK7349; MK7350; MK7351; MK7352; MK7353; MK7354; MK7355; MK7356; MK7357; MK7358; MK7359; MK7360; MK7361; MK7362; MK7363; MK7364; MK7365; MK7366; MK7367; MK7368; MK8000; MK8001; MK8002; MK8003; MK8004; MK8005; MK8006; MK8007; MK8008; MK8074; MK8075; MK8076; MK8077; MK8078; MK8079; MK8080; MK8081; MK8082; MK8083; MK8084; MK8085; MK8086; MK8087; MK8088; MK8089; MK8090; MK8091; MK8092; MK8093; MK8094; MK8095; MK8096; MK8097; MK8098; MK8099; MK8100; MK8101; MK8102; MK8103; MK8104; MK8105; MK8106; MK8107; MK8108; MK8109; MK8110; MK8111; MK8112; MK8113; MK8114; MK8115; MK8116; MK8117; MK8118; MK8119; MK8120; MK8121; MK8122; MK8123; MK8124; MK8125; MK8127; MK9001; MK9002; MK9003; MK9004; MK9005; MK9006; MK9007; MK9008; MK9009; MK9010; MK9012; MK8009; MK8010; MK8011; MK8012; MK8013; MK8014; MK8015; MK8016; MK8017; MK8018; MK8019; MK8020; MK8021; MK8022; MK8023; MK8024; MK8025; MK8026; MK8027; MK8028; MK8029; MK8030; MK8031; MK8032; MK8033; MK8034; MK8035; MK8036; MK8037; MK8038; MK8039; MK8040; MK8041; MK8042; MK8043; MK8044; MK8045; MK8046; MK8047; MK8048; MK8049; MK8050; MK8051; MK8052; MK8053; MK8054; MK8055; MK8056; MK8057; MK8058; MK8059; MK8060; MK8061; MK8062; MK8063; MK8064; MK8065; MK8066; MK8067; MK8068; MK8069; MK8070; MK8071; MK8072; MK8073

Ophthalmic Devices

1

No

Distribution was nationwide and to the following foreign countries: Spain, Taiwan, UK, Mexico, Brazil, India, France, Ireland, China, Lebanon, Germany, Australia, Italy, Saudi Arabia, Greece, Japan, Netherland, Turkey, Korea, Romania, Latvia, Belgium, Switzerland, Malaysia, Thailand, Portugal, Phillipines, Canada, Sweden, Hungary, Argentina, Poland, Norway, Peru, Russia, Venezuela, Vietnam, Ecuador, Ukraine, Cyprus, Singapore, Chile, Nepal, Honduras, Colombia, and the Czech Republic.

SKBM Microkeratome cutting tool

Manufacturing Lot Numbers: 959, 962, 964, 965, and 966

Ophthalmic Devices

1

No

Nationwide

BD K-3000 Microkeratome Blade || REF 378607

Model # 75-2525, Lot #M118200

Ophthalmic Devices

1

No

The product was shipped to 2 wholesale accounts in PA and LA.

Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.

Model number: 52-2761  Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 3/2008

Ophthalmic Devices

1

No

Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.

2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''

Product is not coded.

Ophthalmic Devices

1

No

Product was distributed to a a wholesaler in Florida.

Product is Magnivision UltraLights reading glasses which have the dioptic power on the label and ''MAGNIVISION AN AMERICAN GREETINGS COMPANY Miramar, FL 33025''

M190500 exp 11/2007 and M203840 exp 12/2007

Ophthalmic Devices

1

No

The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.

Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

Lots: #5047293 and #5048892

Ophthalmic Devices

1

No

The product was distributed to customers in OH and PA.

Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.

SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.

Ophthalmic Devices

1

No

Nationwide, Canada and Australia

MicroSTAAR Injector Cartridges Models: || SFC-25 (utilized with plate haptic Collamer lens) || MTC-60 (utilized with plate haptic Silicone lens)

Lot 11853090.   Sterility Date : 11/18/2003 Expiration Date: 10/31/2006

Ophthalmic Devices

1

No

Nationwide.

MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

Model No. Lot # Exp. date 52-2835 M454660 2/2009 52-2835 M317210 7/2008

Ophthalmic Devices

1

No

Distribution was nationwide and internationally

Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm

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.

Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361 M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510 1/2009 56-5161 M317030 6/2008

Ophthalmic Devices

1

No

Distribution was nationwide and internationally

Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm