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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
112-2685769-1/1/1 13-Jul-2011 86HIT 3003342835 C.H. Electronics United Kingdom
 
286-1652864-3/2/1 18-Jul-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1653058-1/3/1 15-Jul-2011 86HLM 3002680900 Tomey Corporation Japan
 
286-1653058-1/2/1 15-Jul-2011 86HLM 3002680900 Tomey Corporation Japan
 
112-9270350-4/1/1 08-Jul-2011 86HQD 1000123221 Visionary Optics, LLC United States
 
112-2687909-1/1/1 11-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2687957-0/1/1 11-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2687973-7/1/1 11-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2687850-7/1/1 11-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3175698-7/1/1 18-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2836227-8/1/1 26-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2936227-7/1/1 27-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2937858-8/1/1 27-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2877001-7/1/1 27-Jul-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
AEK-8458809-0/2/1/A 21-Jul-2011 86HQL 3005284987 Henan Universe Iol R&M Co Ltd China
 
AVB-1046026-5/1/1 08-Jul-2011 86HQY 3004826952 Max Mara Italy
 
112-2881796-6/17/1 08-Jul-2011 86HQY 3008987464 Yicheng Glasses China
 
112-2653065-2/1/1 11-Jul-2011 86HQY 3003522674 Architectures France
 
R12-0043111-1/1/1 19-Jul-2011 86HQY 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
R12-0043111-1/2/1 19-Jul-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0043111-1/3/1 19-Jul-2011 86HQY 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
R12-0043111-1/4/1 19-Jul-2011 86HQY 3001654059 Luxottica SRL Italy
 
U16-4652441-7/3/1 19-Jul-2011 86HQY 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
U16-4652445-8/5/1 19-Jul-2011 86HQY 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
NV3-0041069-7/3/1 19-Jul-2011 86HQY 3008866082 Shenzhen Yululai Trading Co., Ltd. China
 
DP6-0135859-2/2/1 19-Jul-2011 86HQY 3003117010 Argent Optical Manufactory Limited China
 
AEK-8786145-2/1/1 20-Jul-2011 86HQY 3008987914 Sheng Huihuang Electronics Hong Kong SAR
 
AEK-8402623-2/1/1 21-Jul-2011 86HQY 3008549217 Qihang Technology China
 
112-2961243-2/1/1 26-Jul-2011 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
144-4092639-5/1/1 27-Jul-2011 86HQY 3007878105 Wenzhou Oriental Import And Export China
 
112-3278153-9/6/1 29-Jul-2011 86HQY 3009047357 General Textile And Garment Wu Xi Co Ltd China
 
112-2653065-2/2/1 11-Jul-2011 86HQZ 3003522674 Architectures France
 
K51-0072010-8/1/1 18-Jul-2011 86HQZ 3008989050 Hd Importacao E Exportacao Ltda. Brazil
 
EQ6-0013350-6/2/1 18-Jul-2011 86HQZ 3004029025 Viva Eyeware Uk United Kingdom
 
EQ6-0013350-6/1/1 18-Jul-2011 86HQZ 3004029025 Viva Eyeware Uk United Kingdom
 
AEK-8379804-7/1/1 22-Jul-2011 86HQZ 3008903293 Plagg Industries Srl Italy
 
UPS-3008503-5/2/1 28-Jul-2011 86LPL 3009032877 William James United Arab Emirates
 
112-2638671-7/2/1 21-Jul-2011 86LPM 3007189156 Specsavers Optical United Kingdom
 
AEK-8458809-0/2/1/B 21-Jul-2011 86LYL 3005284987 Henan Universe Iol R&M Co Ltd China
 
AEK-8458809-0/1/1 21-Jul-2011 86LZP 3005284987 Henan Universe Iol R&M Co Ltd China
 
XXX-0263616-6/1/1 13-Jul-2011 86MVN 3007564160 Fab Solotica Ind Brazil
 
112-2363643-7/1/1 18-Jul-2011 86MVN 3008930880 Specsavers Uk Limited United Kingdom
 
286-1653058-1/1/1 15-Jul-2011 86NQE 3002680900 Tomey Corporation Japan
 
286-1652864-3/1/1 18-Jul-2011 86NQE 3002680900 Tomey Corporation Japan
 
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