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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
799-1587123-4/61/1 13-Dec-2013 86HJX 3003109041 Well Arts Optical Mfy China
 
799-1830186-6/1/1 27-Dec-2013 86HKN 3004784203 Towa Medical Instruments Co Ltd Japan
 
DU2-0014942-3/1/1 30-Dec-2013 86HKX 3007463982 Lianyungang Tiannuo Optical Inst China
 
799-1458528-0/1/1 13-Dec-2013 86HLC 3003899818 Gentec Electro-Optique Canada
 
D53-1313058-0/18/1 03-Dec-2013 86HLM 3003441816 Shanghai Poly Technologies Co., Ltd. China
 
799-1587123-4/62/1 13-Dec-2013 86HNR 3003408840 Geuder AG Germany
 
799-1587123-4/63/1 13-Dec-2013 86HNR 3003408840 Geuder AG Germany
 
UPS-0704568-7/1/1 03-Dec-2013 86HOI 3007353757 EYEBUYDIRECT DYOPTICAL CO. LTD. China
 
D05-0213729-8/1/1 10-Dec-2013 86HOI 3009736681 Champion Beta Co Ltd China
 
AEK-1735798-5/1/1 24-Dec-2013 86HOI 3010485880 Yiwi Shunghi Import&Export China
 
799-1195385-3/1/1 18-Dec-2013 86HOY 3004782462 Ophtechnics Unlimited India
 
799-1167376-6/1/1 09-Dec-2013 86HPZ 3004553541 Zoom International Venezuela
 
UPS-2944235-9/1/1 09-Dec-2013 86HQD 3010463410 Rossana Meneghello C/O Mbe Italy
 
UPS-3114296-3/1/2 27-Dec-2013 86HQD 3010495325 Pts Worldwide Express Turkey
 
799-1702246-3/1/1 12-Dec-2013 86HQG 3010321731 Novoa Tony Costa Rica
 
231-3863200-9/1/2 27-Dec-2013 86HQG 3009776244 Global Best Way Co.,Ltd. China
 
231-3863200-9/1/1 27-Dec-2013 86HQG 3009776244 Global Best Way Co.,Ltd. China
 
799-1587123-4/12/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/14/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/34/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/11/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/42/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/38/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/43/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/37/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/35/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/27/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/10/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/65/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/33/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/23/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/19/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/13/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/31/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/29/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/18/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/20/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/46/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/44/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/36/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/28/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/26/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/6/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/2/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/47/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/40/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/3/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/5/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/7/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/16/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/17/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/39/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/45/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/15/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/9/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/8/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/4/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/1/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/22/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/30/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/24/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/21/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/32/1 13-Dec-2013 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
UPS-3195908-5/2/1 03-Dec-2013 86HQY 3004865488 Bensol Srl Italy
 
UPS-3195908-5/1/1 03-Dec-2013 86HQY 3003915547 Plastinax Austral Mauritius
 
UPS-3195908-5/4/1 03-Dec-2013 86HQY 3005543139 Argus Vision International Limit Taiwan
 
UPS-3195908-5/3/1 03-Dec-2013 86HQY 3003414205 Heng Gang Glover Optical Manufactory China
 
UPS-3195879-8/1/1 03-Dec-2013 86HQY 3003915547 Plastinax Austral Mauritius
 
UPS-3195879-8/2/1 03-Dec-2013 86HQY 3004865488 Bensol Srl Italy
 
UPS-3195879-8/3/1 03-Dec-2013 86HQY 3003414205 Heng Gang Glover Optical Manufactory China
 
UPS-3195879-8/4/1 03-Dec-2013 86HQY 3005543139 Argus Vision International Limit Taiwan
 
799-1816388-6/1/1 03-Dec-2013 86HQY 3010488559 Wenzhou Changhong Imp & Exp Co China
 
315-3207884-2/4/1 04-Dec-2013 86HQY 3003206030 Dfass Jamaica Limited Jamaica
 
UPS-2197420-1/1/1 04-Dec-2013 86HQY 3006779222 Carl Zeiss Vision Hong Kong SAR
 
UPS-2283014-7/2/1 04-Dec-2013 86HQY 3008784907 Lindberg Ag A4-Branch Philippines
 
AEK-1734033-8/1/1 05-Dec-2013 86HQY 3010483775 Guangzhou J&T Glasses China
 
799-0945274-4/1/1 09-Dec-2013 86HQY 1000543504 Peter'S Eyes Product Inc Taiwan
 
QI3-0096362-9/4/1 09-Dec-2013 86HQY 3008252166 Taizhou City Jiaojiang Dongda Glasses Factory China
 
JF7-0108639-5/2/1 12-Dec-2013 86HQY 3002851271 Luxottica Group Spa Italy
 
UPS-2912882-6/2/1 12-Dec-2013 86HQY 3006045530 NINGBO B&B INTERNATIONAL TRADING CO., LTD China
 
799-1074194-5/14/1 18-Dec-2013 86HQY 3008252124 Wenzhou Savvy Import & Export Co., Ltd. China
 
799-1074194-5/14/2 18-Dec-2013 86HQY 3006755664 Wenzhou Royal Optical Co., Ltd China
 
799-1074194-5/14/3 18-Dec-2013 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
799-1074194-5/14/4 18-Dec-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-1074194-5/14/6 18-Dec-2013 86HQY 3009103030 WENZHOU SUNRISE INDUSTRIAL AND TRADING CO. LTD. China
 
799-1074194-5/14/7 18-Dec-2013 86HQY 3004868401 Wenzhou Union Eyewear Co., Ltd. China
 
799-0929746-1/3/1 18-Dec-2013 86HQY 3009549392 Linhai Tianma Glasses Factory China
 
97U-0001481-3/3/1 19-Dec-2013 86HQY 3007475580 Luxin Optical China
 
799-1078985-2/1/1 20-Dec-2013 86HQY 3007151659 Sel Optical Divi.Filtri Solari Italy
 
799-1005039-6/1/1 20-Dec-2013 86HQY 3010397685 Alex Palencia Perez Spain
 
231-3864262-8/1/1 23-Dec-2013 86HQY 3007124039 BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD Taiwan
 
AEK-1740749-1/3/1 24-Dec-2013 86HQY 3010489971 Custom 6 Srl Italy
 
799-0745846-1/1/1 24-Dec-2013 86HQY 3010336232 Usa111 China
 
UPS-0709444-6/1/1 26-Dec-2013 86HQY 3010146080 Ghetaldus Costa Rica
 
315-3205609-5/1/1 26-Dec-2013 86HQY 3010418091 Premier Portfolio Int United Kingdom
 
315-3205609-5/2/1 26-Dec-2013 86HQY 3010418091 Premier Portfolio Int United Kingdom
 
799-1031450-3/1/1 27-Dec-2013 86HQY 3010401071 Zhejiang Weekmorning Commodity C China
 
UPS-3204515-7/1/1/A 31-Dec-2013 86HQY 3003689913 Iwear Inc Canada
 
UPS-3204515-7/1/1/B 31-Dec-2013 86HQY 3003689913 Iwear Inc Canada
 
K80-2010227-4/63/1 31-Dec-2013 86HQY 3010283952 Dragonmarts Trading Co Ltd China
 
UPS-2283014-7/1/1 04-Dec-2013 86HQZ 3008784907 Lindberg Ag A4-Branch Philippines
 
JF7-0108639-5/1/1 12-Dec-2013 86HQZ 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
799-1702246-3/2/1 12-Dec-2013 86HQZ 3010321731 Novoa Tony Costa Rica
 
799-1031279-6/1/1 13-Dec-2013 86HQZ 3008358381 Framers Gmbh Germany
 
AEK-1140571-5/1/1 19-Dec-2013 86HQZ 3010185811 Buldey Co Sa Uruguay
 
799-1160374-8/1/1 20-Dec-2013 86HQZ 3005024032 Wenzhou Grand Optical Co., Ltd. China
 
AEK-1740749-1/1/1 24-Dec-2013 86HQZ 3010489971 Custom 6 Srl Italy
 
799-1210594-1/1/1 09-Dec-2013 86LPL 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
AEK-7843538-1/1/1/A 11-Dec-2013 86LPL 3002806417 Coopervision Manufacturing, Ltd. United Kingdom
 
AEK-7843538-1/1/1/B 11-Dec-2013 86LPL 1053053 Alcon Laboratories, Inc. United States
 
XXX-0196802-4/1/3 27-Dec-2013 86LPL 3006275055 Coopervision United Kingdom
 
799-1230165-6/1/1 09-Dec-2013 86LPM 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
799-1424488-8/1/1 12-Dec-2013 86LPM 3009848126 Aargee United Kingdom
 
799-1159225-5/1/1 18-Dec-2013 86LPM 3010340706 Newbio Co Ltd Korea, Republic Of (South)
 
799-1156836-2/1/1 18-Dec-2013 86LPM 3010340706 Newbio Co Ltd Korea, Republic Of (South)
 
799-1443608-8/1/1 18-Dec-2013 86LPM 3009674807 Neo Vision Co Ltd Korea, Republic Of (South)
 
799-1624048-8/1/1 27-Dec-2013 86LPM 3005473668 Lab Pfortner Argentina
 
799-1587123-4/55/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/54/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/60/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/52/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/49/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/51/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/57/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/59/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/56/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/50/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/48/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/58/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1587123-4/53/1 13-Dec-2013 86MML 3002807445 Labtician Ophthalmics Inc. Canada
 
799-1420341-3/1/1 20-Dec-2013 86MSR 3008945575 Infushion Equipments Inc India
 
UPS-2888279-5/1/1 13-Dec-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
799-1043788-2/1/1 13-Dec-2013 86MVN 3002806704 Ciba Vision GmbH Germany
 
799-1134110-9/1/1 20-Dec-2013 86MVN 3010340706 Newbio Co Ltd Korea, Republic Of (South)
 
799-1252657-5/1/1 09-Dec-2013 86MWL 3010425830 Scotlens Limited United Kingdom
 
UPS-2891063-8/1/1 13-Dec-2013 86MWL 3010313540 Navsarka ltd United Kingdom
 
UPS-2888240-7/1/1 13-Dec-2013 86MWL 3010313540 Navsarka ltd United Kingdom
 
799-1093462-3/1/1 20-Dec-2013 86MWL 3008845532 Wave Contact Lens System Llc United States
 
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