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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 86-Ophthalmic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AYF-0061899-7/10/1 30-Sep-2013 86HLF 3010328167 3t Company China
 
256-0153946-0/1/1 03-Sep-2013 86HLI 3010244180 Taichi Corporation Japan
 
256-0153946-0/1/2 03-Sep-2013 86HLI 3010244180 Taichi Corporation Japan
 
256-0153946-0/1/3 03-Sep-2013 86HLI 3010244180 Taichi Corporation Japan
 
799-0469267-4/1/1 17-Sep-2013 86HLM 3010163465 Ninbgo Flo Optical Technology Develoopment China
 
AYF-0061899-7/13/1 30-Sep-2013 86HLN 3010328167 3t Company China
 
UPS-4847594-5/14/1 13-Sep-2013 86HOI 3004101655 Lanson Optical Co., Ltd. China
 
799-0925632-7/1/1 26-Sep-2013 86HOI 3010374635 Nunettes France
 
799-0507037-5/1/1 26-Sep-2013 86HOX 3005619472 T.M.I. Company, Limited Japan
 
DSV-7001324-5/14/1 25-Sep-2013 86HOY 3004673044 Martin Professional A/S Denmark
 
UPS-1879973-6/1/1 17-Sep-2013 86HQD 3011063182 Polytouch Co Ltd Korea, Republic Of (South)
 
APS-0104214-4/6/1 04-Sep-2013 86HQY 3002719961 Marcolin S.p.A. Italy
 
APS-0104214-4/5/1 04-Sep-2013 86HQY 3001654059 Luxottica SRL Italy
 
APS-0104214-4/4/1 04-Sep-2013 86HQY 3003116697 Safilo Group S.p.A. Italy
 
DO7-8292912-2/3/1 05-Sep-2013 86HQY 3010149383 Capital Logistics United Kingdom
 
BNW-0134583-5/19/1 05-Sep-2013 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
AEK-9207833-2/1/1 05-Sep-2013 86HQY 3009836713 Prescription Eyewear Limited United Kingdom
 
799-0309874-1/2/1 06-Sep-2013 86HQY 3005334925 Parasite Design France
 
799-0472386-7/1/1 09-Sep-2013 86HQY 3010297528 Huaan China
 
799-0471892-5/1/1 09-Sep-2013 86HQY 3010297528 Huaan China
 
799-0473581-2/1/1 10-Sep-2013 86HQY 3010286588 Shenzhen Smartlink Technology Co China
 
799-0490637-1/1/1 13-Sep-2013 86HQY 3010338252 Wenzhou Phisense Optical Co Ltd China
 
UPS-4847594-5/18/1 13-Sep-2013 86HQY 3004101655 Lanson Optical Co., Ltd. China
 
799-0473676-0/1/1 16-Sep-2013 86HQY 3010336267 Weiyi Glasses Factory China
 
R12-0047022-6/1/1 17-Sep-2013 86HQY 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
R12-0047022-6/2/1 17-Sep-2013 86HQY 2083323 Oakley Inc United States
 
R12-0047022-6/3/1 17-Sep-2013 86HQY 3009447717 Luxottica Srl Italy
 
R12-0047022-6/4/1 17-Sep-2013 86HQY 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
R12-0047022-6/5/1 17-Sep-2013 86HQY 2083323 Oakley Inc United States
 
UPS-2457788-6/2/1 23-Sep-2013 86HQY 3006737843 Lakeside Logistics Canada
 
AEK-9209234-1/1/1 23-Sep-2013 86HQY 3004215865 Feiyue Optical Co., Ltd. China
 
175-3117479-9/1/1 23-Sep-2013 86HQY 3003499479 Wenzhou M & C Foreign Trade Co., Ltd. China
 
799-0590919-2/1/1 24-Sep-2013 86HQY 3010350255 China Oken Group Co Ltd China
 
799-0548303-2/1/1 24-Sep-2013 86HQY 3010359322 Yi Wu Dhgate Company China
 
UPS-8222364-8/2/1 24-Sep-2013 86HQY 3010314910 Yiwu Demeiya Apparel Co Ltd China
 
JF7-0106595-1/2/1 26-Sep-2013 86HQY 3002851271 Luxottica Group Spa Italy
 
799-0908132-9/3/1 27-Sep-2013 86HQY 3005051914 Actra Intl Co Ltd Taiwan
 
799-0499004-5/1/1 30-Sep-2013 86HQY 3010339262 Jiaojiang Glasses Factory China
 
315-8162324-1/1/1 30-Sep-2013 86HQY 3007304915 SOLAR ZONE OPTICAL INC. China
 
112-3787917-2/1/1 03-Sep-2013 86HQZ 3004049933 Forbes View Limited China
 
APS-0104214-4/1/1 04-Sep-2013 86HQZ 3003116697 Safilo Group S.p.A. Italy
 
APS-0104214-4/3/1 04-Sep-2013 86HQZ 3002719961 Marcolin S.p.A. Italy
 
APS-0104214-4/2/1 04-Sep-2013 86HQZ 3001654059 Luxottica SRL Italy
 
799-0295678-2/1/1 05-Sep-2013 86HQZ 3004535542 Schnuchel Germany
 
799-0275518-4/1/1 05-Sep-2013 86HQZ 3004535542 Schnuchel Germany
 
799-0274912-0/1/1 05-Sep-2013 86HQZ 3004535542 Schnuchel Germany
 
112-3614725-8/1/1 05-Sep-2013 86HQZ 3009305521 Reiz Germany Germany
 
DO7-8293801-6/2/1 05-Sep-2013 86HQZ 3003191457 Wood Optic Diffusion Luxembourg
 
DO7-8293801-6/4/1 05-Sep-2013 86HQZ 3003191457 Wood Optic Diffusion Luxembourg
 
799-0309874-1/1/1 06-Sep-2013 86HQZ 3005334925 Parasite Design France
 
799-0461227-6/1/1 13-Sep-2013 86HQZ 3004535542 Schnuchel Germany
 
UPS-4847594-5/12/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/11/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/10/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/13/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/2/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/3/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/5/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/6/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/1/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/9/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/8/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/7/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
UPS-4847594-5/4/1 13-Sep-2013 86HQZ 3004101655 Lanson Optical Co., Ltd. China
 
799-0643957-9/1/1 20-Sep-2013 86HQZ 3002646404 Irene Corporation Taiwan
 
799-0564327-0/1/1 23-Sep-2013 86HQZ 3009818927 Occhiale Italiano Italy
 
799-0610383-7/1/1 23-Sep-2013 86HQZ 3010094469 Epathchina Technology Co Ltd China
 
AEK-9209919-7/1/1 23-Sep-2013 86HQZ 3010354504 Yingling Optical Co Ltd China
 
JF7-0106595-1/1/1 26-Sep-2013 86HQZ 3002851271 Luxottica Group Spa Italy
 
799-0535548-7/1/1 30-Sep-2013 86HQZ 3008203195 Herrlicht Germany
 
224-4520230-6/1/1 30-Sep-2013 86HQZ 3004160225 Miraflex Ltda Colombia
 
112-3662623-6/1/1 05-Sep-2013 86LPL 3001018555 CENTRO STYLE S.P.A. Italy
 
799-0622825-3/1/1 20-Sep-2013 86LPL 1053053 Alcon Laboratories, Inc. United States
 
H77-0137684-7/7/1 05-Sep-2013 86LPN 3008338620 LUCKY SEVEN INDUSTRIES (PVT) LTD Pakistan
 
AEK-9206175-9/2/1 23-Sep-2013 86MVN 3010343076 Sin Chew Optics Contact Lens Centre Singapore
 
799-0556409-6/1/1 30-Sep-2013 86ORZ 3010346431 Teod Science Canada
 
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